Literature DB >> 35312733

Evaluation of ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices.

Boonsong Wanichwecharungruang1,2, Anyarak Amornpetchsathaporn1, Wisakorn Wongwijitsook1, Kittipong Kongsomboon3, Somporn Chantra1.   

Abstract

PURPOSE: To investigate agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in various ocular biometry and intraocular lens (IOL) calculations of primary angle-closure disease (PACD).
SETTING: Rajavithi Hospital, Bangkok, Thailand.
DESIGN: Prospective comparative study.
METHODS: This study conducted in a tertiary eye care center involving biometric measurements obtained with 2 devices in phakic eye with diagnosis of PACD. Mean difference and intraclass correlation coefficient (ICC) with confidence limits were assessed, and calculations of estimated residual refraction of the IOL were analysed using Barrett's formula.
RESULTS: Sixty-nine eyes from 45 PACD patients were enrolled for the study. Excellent agreement of various parameters was revealed, with ICC (confidence limits) of K1 = 0.953 (0.861-0.979), K2 = 0.950 (0.778-0.98), ACD = 0.932 (0.529-0.978), WTW = 0.775 (0.477-0.888), and LT = 0.947 (0.905-0.97). Mean difference of axial length (AL) was -0.01 ± 0.02 mm with ICC of 1.000. IOL calculation was assessed with Barrett's formula, and Bland-Altman plot showed excellent agreement in the results of the 2 devices for the IOL power and estimated post-operative residual refraction (EPR).
CONCLUSIONS: Mean differences of biometric parameters, obtained with IOL Master700 and Anterion, were small, and ICC showed excellent concordance. No clinical relevance in calculation of IOL power was found, and the two devices appeared to be comparably effective in clinical practice.

Entities:  

Mesh:

Year:  2022        PMID: 35312733      PMCID: PMC8936461          DOI: 10.1371/journal.pone.0265844

Source DB:  PubMed          Journal:  PLoS One        ISSN: 1932-6203            Impact factor:   3.240


Introduction

Primary angle-closure glaucoma (PACG) is one of the leading causes of irreversible blindness worldwide. Its global prevalence is showing an upward trend, and it is expected to reach about 66.8 million cases by 2040. Its prevalence is highest in Asia, and people from this regiohave the greatest number of cases of blindness resulting from glaucoma [1]. Primary angle-closure disease (PACD) is a spectrum of this eye condition, including primary angle-closure suspect (PACS), primary angle-closure (PAC) and PACG. PACD is an anatomic disorder, typically of relatively small eye with shallow anterior chamber depth (ACD), thick lens, shorter axial length (AL), small corneal curvature, and relatively anterior lens position. Pupillary block, plateau iris and phacomorphic mechanisms play major roles in the pathophysiology of the disease, and pupillary block is thought to be the most common causal mechanism. Laser peripheral iridotomy (LPI) alleviates the effects of pupillary block; however, in the LIWAN study, 58% of patients were found to still have apposition irido-corneal angle [2]. Irido-corneal angle can be closed by a crowded anterior chamber, leading to intraocular pressure (IOP) elevation and glaucomatous optic neuropathy (GON) resulting in visual field loss and irreversible blindness in these patients. Visual field loss in PACD appears to be worse than in primary open-angle glaucoma (POAG) [3]. For decades, phacoemulsification and intraocular lens implantation (PEI) has been proposed for initial management of PACD [4, 5]. PEI relieves pupillary block, deepening ACD and widening irido-corneal angle [6], while at the same time preserving the conjunctiva for future trabeculectomy if needed. Biometry is essential in evaluating ocular dimensions and calculating IOL power in PACD, and ocular biometers have been evolving in recent years. Optical coherence tomography (OCT) includes partial coherence interferometry (PCI), and swept source OCT (SS-OCT) is in general use in clinical practice. The agreement of the calculations of these devices has been studied by many investigators; however, research into their agreement in PACD patients has been sparse so far. A newer SS-OCT, Anterion, is now available and its performance needs to be evaluated.

Materials and methods

A prospective comparative study of ocular biometry of 2 devices, IOLMaster 700 (Carl Zeiss Meditec, CA, USA) and Anterion (Heidelberg Engineering GmbH, Germany), for use with PACD patients, was conducted in a referral eye center, in Rajavithi Hospital, Ministry of Public Health of Thailand. The research protocol was approved by the Ethics Committee Rajavithi Hospital in April 2020, and the study was performed between May and December 2020 following all of the guidelines for experimental investigation in human subjects required by the Ethics Committee. All investigations were carried out in accordance with the Declaration of Helsinki, and informed consent forms were read and signed by all participants.

Inclusion and exclusion criteria

We enrolled participants from the glaucoma clinic at Rajavithi Hospital, Bangkok, Thailand. Inclusion criteria were age ≥ 40 years old and phakic eye with diagnosis of PACD, including PACS, PAC, and PACG as classified by Foster et al [7]. PACS was defined as Shaffer’s gonioscopic grading ≤ 2 in at least 2 quadrants, with normal IOP and without glaucomatous optic disc and visual field defect; PAC was classified as PACS with IOP > 21 mmHg, presence of PAS and without any glaucomatous changes; and PACG was defined as PAC with glaucomatous changes. Patients who had glaucoma medication or previous laser treatment (iridotomy, iridoplasty, trabeculoplasty) were eligible. Exclusion criteria were patients who had opaque optical media, dense cataract, anterior and/or posterior segment diseases such as advanced pterygium, diabetic retinopathy, or maculopathy. Participants who had previous history of ocular trauma, ocular surgery, e.g., refractive surgery, cataract, glaucoma (trabeculectomy and/or glaucoma tube shunt), and vitreoretinal surgery were also excluded.

Examinations

Ocular examination including Snellen visual acuity with logMar conversion, autorefraction (RC-5000, Tomey, Japan), slit lamp, Goldman applanation tonometry, cup/disc (C/D) and fundus ophthalmoscopy were evaluated. Dynamic gonioscopy was performed for all patients by a senior glaucoma specialist (BW).

Swept source OCT devices

Swept source OCT has been an emerging technology for IOL calculation for a number of years. SS-OCT applies a tunable light source to a beam splitter, diverting one arm of the scanning beam to the ocular structure and the other to a reference mirror. Both of the coherence beams reflect to the point detector, assessing Fourier transformation to calculate ocular dimensions [8]. IOL Master700 applies a 1050 nm light source with 2,000 A scan/sec, capturing scan depth of 44 mm and axial resolution of 22 microns, while Anterion applies a 1,300 nm light source with 50,000 A scan/sec, capturing 32 mm scan depth, 16.5 mm scan width, axial resolution < 10 microns and lateral resolution of 30–45 microns [8]. The 2 devices, IOLMaster700 and Anterion, were scanned in random sequences by trained technicians within the same visit in a standard illuminated room. No pupillary dilation was required. We checked all image quality and segmentation to ensure that the devices were correctly marked. Biometric parameters of ACD, AL, LT, K1, K2, astigmatism, and white to white corneal diameter (WTW) were recorded in Excel and transferred to SPSS (version 20, SPSS inc., IBM, Chicago, USA) for analyses.

Sample size estimation

Sample size calculation was performed using the formula for estimating correlation coefficient with a type I error (α) of 0.05 and type II error (β) of 0.2. The authors estimated the correlation of the devices, using the correlation coefficient (r) of 0.7 for the sample size calculation. The standard normal deviate for α = Zα = 1.9600 The standard normal deviate for β = Zβ = 0.8416 The output indicated that at least 13 subjects should be enrolled. And, in the anticipation of a dropout rate of 30%, the minimum sample size required was 17.

Outcome measurement and statistical analyses

We tested normal distribution of data with Kolmogorov-Smirnov test. Comparison of the biometric parameters were analyzed with independent t-test for parametric datasets, and Mann-Whitney U test was used for non-parametric datasets. Statistical significance was set at p < 0.05. The main outcome measured was agreement of the biometric parameters of the 2 devices. Intraclass correlation coefficient (ICC) and confidence limits were analyzed. ICC was classified as follows: < 0.4, poor; 0.4–0.59, fair; 0.60–0.74, good; and 0.75–1.00, excellent agreement [9]. Subgroup analyses of PACD patients who had ACD < 2.4 mm and > 2.4 mm were performed, and agreement of IOL calculation by the 2 devices was also analyzed. We assessed estimated IOL power and estimated residual post-operative refraction with Barrett Universal II online formula (https://calc.apacrs.org/barrett_universal 2105, accessed July 15, 2021). The formula required AL, K1, K2, and ACD, with option of LT and WTW. We used an IOL model SN60WF (Alcon Laboratories, Fort Worth, TX, USA) with A constant 119.0 for the formula. Bland-Altman plot was constructed for the IOL power and the EPR.

Results

We recruited 50 patients for this research. Two patients were excluded because of dense cataract and failure to be scanned with both devices, and a further three patients were excluded because they had epiretinal membrane (2 patients) and severe dry eye (1 patient). Seventy PACD eyes from 45 patients, 16 males and 29 females, were therefore enrolled in the study. Anterion failed to obtain AL in one eye; therefore, 69 eyes were analyzed. Mean age, visual acuity, spherical equivalent, IOP and cup-to-disc ratio are displayed in Table 1.
Table 1

Number of PACD patients and their demographic data.

DataPACD
Number of patients45
 • Male16 (35.6%)
 • Female29 (64.4%)
 Number of eyes69
Age (years)63.27±8.01 (48–77)
Diagnosis, N eye (%)
 • PACS45 (65.22%)
 • PAC11 (15.94%)
 • PACG13 (18.84%)
Visual acuity (logMAR)0.32±0.48 (0.0–2.7)
Spherical equivalent (D)0.45±1.97 (-4.0–5.5)
Intraocular pressure (mmHg)16.54±4.27 (6–34)
Cup-to-disc ratio0.62±0.19 (0.3–1.0)

PACD: Primary angle closure disease, PACS: Primary angle closure suspect, PAC: Primary angle closure

PACG: Primary angle closure glaucoma, D: diopter(s)

PACD: Primary angle closure disease, PACS: Primary angle closure suspect, PAC: Primary angle closure PACG: Primary angle closure glaucoma, D: diopter(s) Ocular biometry of PACD demonstrated that each biometry carried out, except the EPR of IOL model SN60WF, showed significant differences between the 2 devices (Table 2). Mean difference was small in AL, at—0.01 ± 0.02 mm, and EPR, at 0.01 ± 0.17 D. Intraclass correlation coefficient of all parameters demonstrated excellent agreement between the 2 devices, and ICC of AL was 1.000:
Table 2

Comparison of various biometry and intraclass correlation coefficient between IOLMaster700 and Anterion in PACD.

ParameterIOLMaster 700AnterionMean difference ±SDP valueICCConfident limit
Mean ± SDMean ± SDlowerupper
ACD (mm)2.48 ± 0.372.58 ± 0.33-0.10 ± 0.09<0.001a*0.9320.5290.978
AL (mm)22.94 ± 0.8322.95 ± 0.83-0.01 ± 0.020.003a*1.00011
K1 (D)43.66 ± 1.2243.47 ± 1.180.20 ± 0.29<0.001a*0.9530.8610.979
K2 (D)44.62 ± 1.3744.37 ± 1.280.25 ± 0.27<0.001a*0.9500.7780.98
LT (mm)5.00 ± 0.325.04 ± 0.30-0.04 ± 0.100.003a*0.9470.9050.97
WTW (mm)11.71 ± 0.4411.52 ± 0.510.19 ± 0.28<0.001a*0.7750.4770.888
LAF2.18 ± 0.172.20 ± 0.17-0.02 ± 0.040.005a*0.9670.9410.981
IOL power (D)22.30 ± 2.2322.64 ± 2.34-0.34 ± 0.34<0.001b*0.9780.8310.993
EPR (D)0.00 ± 0.11-0.02 ± 0.110.01 ± 0.170.488 b-0.249-0.461-0.11

Values are presented as mean ± SD,

* = significant P value <0.05

a p-value by independent t-test

b p-value by Mann-Whitney U test

PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Values are presented as mean ± SD, * = significant P value <0.05 a p-value by independent t-test b p-value by Mann-Whitney U test PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Subgroup analysis in PACD

We performed subgroup analysis at cut off ACD of 2.4 mm, obtained with the IOLMaster700. From the 69 eyes, we had 24 with ACD ≤ 2.4 mm and 45 with ACD > 2.4 mm.

Subgroup ACD ≤ 2.4 mm

Ocular biometry of the eyes with ACD equal to or less than 2.4 mm measured by IOLMaster 700 demonstrated that all biometries, except of the LT, LAF and EPR, were significantly different between the 2 devices. Mean difference of EPR was 0 ± 0.11 D. Mean difference of AL was close to zero and ICC was 1.000. The other parameters demonstrated excellent agreement between the 2 devices: (Table 3).
Table 3

Comparison of various biometry and intraclass correlation coefficient in PACD with ACD ≤ 2.4 mm, between IOLMaster700 and Anterion.

ParameterIOLMaster 700AnterionMean difference ±SDP valueICCConfident limit
Mean ± SDMean ± SDlowerupper
ACD (mm)2.13 ± 0.272.25 ± 0.18-0.13 ± 0.14<0.001b*0.7010.1760.885
AL (mm)22.75 ± 0.8022.76 ± 0.80-0.01 ± 0.020.017a*1.0000.9991
K1 (D)43.78 ± 1.3843.56 ± 1.340.22 ± 0.25<0.001a*0.9710.8240.991
K2 (D)44.80 ± 1.6844.53 ± 1.610.27 ± 0.23<0.001a*0.9780.7120.994
LT (mm)5.15 ± 0.235.17 ± 0.21-0.02 ± 0.140.583a0.8190.6260.917
WTW (mm)11.54 ± 0.5011.31 ± 0.600.23 ± 0.33<0.001b*0.7640.3990.903
LAF2.27 ± 0.112.28 ± 0.11-0.00 ± 0.060.706a0.8620.7030.939
IOL power (D)22.60 ± 1.5523.00 ± 1.68-0.40 ± 0.36<0.001a*0.9480.5560.985
EPR (D)0.00 ± 0.11-0.02 ± 0.130.02 ± 0.190.584b-0.269-0.6270.159

Values are presented as mean ± SD

* = significant P value <0.05

a p-value by independent t-test,

b p-value by Mann-Whitney U test

PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Values are presented as mean ± SD * = significant P value <0.05 a p-value by independent t-test, b p-value by Mann-Whitney U test PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Subgroup with ACD > 2.4 mm

Ocular biometry of eyes with ACD of more than 2.4 mm measured by IOLMaster 700 demonstrated that all biometries, except the EPR of IOL model SN60WF, were significantly different between the 2 devices. All parameters measured by the two devices demonstrated excellent agreement (Table 4).
Table 4

Comparison of various biometry and intraclass correlation coefficient in PACD with ACD >2.4 mm, between IOLMaster700 and Anterion.

ParameterIOLMaster 700AnterionMean difference ±SDP valueICCConfident limit
Mean ± SDMean ± SDlowerupper
ACD (mm)2.68 ± 0.252.77 ± 0.24-0.08 ± 0.02<0.001b*0.9450.0070.989
AL (mm)23.07 ± 0.8523.07 ± 0.85-0.01 ± 0.020.01a1.00011
K1 (D)43.64 ± 1.1443.45 ± 1.110.19 ± 0.27<0.001b*0.9580.8590.982
K2 (D)44.57 ± 1.1744.32 ± 1.070.25 ± 0.29<0.001a*0.9440.7170.98
LT (mm)4.92 ± 0.344.97 ± 0.32-0.05 ± 0.06<0.001a*0.9730.8640.99
WTW (mm)11.79 ± 0.3811.62 ± 0.430.17 ± 0.25<0.001b*0.7530.4230.884
LAF2.14 ± 0.182.18 ± 0.18-0.02 ± 0.02<0.001a*0.9840.9160.994
IOL power (D)22.03 ± 2.5322.35 ± 2.64-0.31 ± 0.33<0.001b*0.9850.8890.995
EPR (D)0.00 ± 0.10-0.01 ± 0.100.01 ± 0.160.718b-0.226-0.5010.084

Values are presented as mean ± SD

* = significant P value <0.05

a p-value by independent t-test

b p-value by Mann-Whitney U test

PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Values are presented as mean ± SD * = significant P value <0.05 a p-value by independent t-test b p-value by Mann-Whitney U test PACD: Primary angle closure disease, ACD: Anterior chamber depth, AL: Axial length, K: Keratometry, LT: Lens thickness, WTW: White-to-white corneal diameter, LAF: Lens-axial length factor, EPR: Estimated post-operative residual refraction, ICC: intraclass correlation coefficient, IOL: intraocular lens, D: diopter(s)

Intraocular lens calculation and estimation of residual post-operative refraction

We applied the required biometric parameters of both devices to Barrett Universal II formula for IOL calculation. The IOL power differences between the devices’ measurements are shown with Bland-Altman plot (Figs 1A–1C and 2A–2C):
Fig 1

The Bland-Altman plot of the IOL power using parameters from IOLMaster700 and Anterion.

The solid line represents the mean difference, whereas dotted lines on both sides represent the upper and lower 95% LoA. A: In all PACD eyes, The plot demonstrates that only two eyes from total 69 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power. B: In the eyes with ACD≤2.4 mm, The plot demonstrates that only one eye from 24 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power. C: In the eyes with ACD>2.4 mm. The plot demonstrates that only one eye from 45 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power.

Fig 2

The EPR between the devices’ measurements.

The Bland-Altman plot of the EPR using parameters from IOLMaster700 and Anterion of all PACD eyes. The solid line represents the mean difference, whereas dotted lines on both sides represent the upper and lower 95% LoA. A: In all PACD eyes, the plot demonstrates that all cases were within the 95% LoAs, indicating excellent agreement in EPR. B: In the eyes with ACD ≤ 2.4 mm, all cases were within the 95% LoAs, which indicates excellent agreement between the devices. C: In the eyes with ACD > 2.4 mm, the plot demonstrates that only one eye was out of the 95% LoAs, indicating excellent agreement between the devices.

The Bland-Altman plot of the IOL power using parameters from IOLMaster700 and Anterion.

The solid line represents the mean difference, whereas dotted lines on both sides represent the upper and lower 95% LoA. A: In all PACD eyes, The plot demonstrates that only two eyes from total 69 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power. B: In the eyes with ACD≤2.4 mm, The plot demonstrates that only one eye from 24 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power. C: In the eyes with ACD>2.4 mm. The plot demonstrates that only one eye from 45 eyes were out of the 95% LoAs, indicating excellent agreement in IOL power.

The EPR between the devices’ measurements.

The Bland-Altman plot of the EPR using parameters from IOLMaster700 and Anterion of all PACD eyes. The solid line represents the mean difference, whereas dotted lines on both sides represent the upper and lower 95% LoA. A: In all PACD eyes, the plot demonstrates that all cases were within the 95% LoAs, indicating excellent agreement in EPR. B: In the eyes with ACD ≤ 2.4 mm, all cases were within the 95% LoAs, which indicates excellent agreement between the devices. C: In the eyes with ACD > 2.4 mm, the plot demonstrates that only one eye was out of the 95% LoAs, indicating excellent agreement between the devices.

Descriptive data of IOL calculation

IOL power, calculated by IOLMaster700 and Anterion, was shown as: Same IOL power: 24 eyes (34.8%) ±0.5 D: 39 eyes (56.5%) ±1 D: 6 eyes (8.7%)

Discussion

The present study demonstrated excellent agreement between the 2 SS-OCT devices in biometric measurement of PACD and its subgroups. Mean difference of AL in the present study was close to zero, -0.01 ± 0.02 mm, and ICC of AL was 1.000. Since, AL is a key factor for IOL calculation, Bland-Altman plot of the estimated residual refraction with Barrett formula showed that no case was outside the 95% LoA. Excluding dense cataract, both devices had high rates of successful scanning. Only 1 of the eye (1.4%) measurements of AL by Anterion failed; therefore, they appeared to be comparably useful in IOL calculation. Optical biometry has been widely used in ophthalmic clinics for many years, constituting non-contact, non-invasive systems for IOL calculation. IOL Master500 (Carl Zeiss Meditec, CA, USA), a partial coherence interferometry (PCI) biometer, was one of the pioneers in the field. A newer platform of SS-OCT, namely IOL Master700, demonstrates good agreement with IOL Master500 [10], and it is being adopted as a substitute for its predecessor. Anterion, a recent SS-OCT, has been studied for intra-device repeatability of biometric measurement. Ruiz-Mesa et al evaluated the repeatability of Anterion for measurement of ACD, AL, CCT, and LT, resulting in overall ICC > 0.92 [11]. The same investigative group recorded repeatability for anterior segment measurement, e.g., WTW, angle opening distance (AOD), spur to spur (STS), and trabecular iris space area (TISA), achieving overall ICC > 0.97 [12]. In addition, they reported good repeatability for the whole cornea parameters with ICC > 0.98 [13]. Schiano-Lomoriello et al [14] evaluated repeatability of Anterion, showing ICC > 0.98, with coefficient of variation of CCT, corneal diameter (CD), ACD, LT, and AL < 1%. Intra-device repeatability of Anterion indicates its potential for application in IOL calculation and glaucoma evaluation. There have been some comparative studies of agreement between IOL Master700 and Anterion. Fisus et al evaluated biometry measurements taken by the devices in 389 eyes of 209 subjects and found that mean absolute difference of keratometry, ACD, LT, AL were significantly different [15]. However, concordance between the devices was high, with differences that were not clinically relevant in IOL calculation. Oh et al [16] reported mean difference of AL 0.005 mm, with ICC 0.999 in their study of 47 eyes of 29 patients. CCT, ACD and keratometry revealed excellent agreement as well. Tana-Rivero et al reported good concurrence of WTW with mean difference of -0.11 mm [17]. Furthermore, Anterion showed good agreement in various biometric parameters with other biometers, e.g. IOL Master500 (a PCI system) [14, 18], Pentacam (Scheimpflug system) [19], MS 39 (combined placido disk and AS-OCT) [14], and CASIA SS 100 (SS-OCT) [20]. Anterion could be applied for reliable irido-corneal angle evaluation prior to and after LPI in PACD patients [21]. PACD and cataracts commonly occur in elderly patients. Thick or anterior position of the lens can affect the iridocorneal angle, leading to acute PAC (APAC) or chronic PACD [22]. PEI appears to be a potential treatment for PACD, achieving good results in IOP control for APAC. Jacobi et al reported that PEI had high success rates in tonometric control in patients who had high ratios of LAF [23]. The EAGLE study demonstrated that clear lens extraction in PACD with initial IOP > 30 mmHg achieved better IOP control than LPI [24]. PEI not only solves glaucoma problems but also improves vision; therefore, accuracy of IOL calculation must be considered in this group of patients. We applied Barrett formula for IOL calculation in this study. This formula is one of the most accurate and has been widely used, as it has been shown by many studies to achieve better postoperative outcomes than any other formula [25, 26]. The present research demonstrated a significant difference in mean IOL power of 22.30 ± 2.23 D and 22.64 ± 2.34 D from the devices (p< 0.001); however, the arithmetic difference may not have much effect on IOL power selection, since the IOL power is available in 0.5 D increments in every IOL model. We identified that 91.3% of the calculated IOL powers were within ± 0.5 D, and 8.7% were within ± 1 D. As a 1D error in IOL power is equivalent to an error of about 0.67 D in the spectacle plane [27], it appeared to be of no relevance for IOL selection. Prospective evaluation of post-operative IOL accuracy of patients is an ongoing project in our clinic. Anterior chamber depth is an important parameter for PACD evaluation. Shallow ACD cause irido-trabecular contact, leading to PAS formation and IOP elevation. Marked shallow ACD tends to trigger a severe type of acute attack in PACD. Marchini et al reported ACD, obtained with ultrasonic A-scan, of acute/intermittent PACD, chronic PACD and normal controls as 2.41, 2.77, and 3.3 mm respectively [28]. With OCT systems, our study showed mean ACD of 2.49 and 2.58 mm. IOLMaster700 showed shorter ACD than Anterion, with mean difference of -0.10 mm, and Fisus et al demonstrated a similar result in their cataract patients [15]. The difference might be related to the algorithm of segmentation of the anterior segment structure: IOLMaster700 determines ACD with the axial distance of anterior cornea to the anterior lens capsule, whereas Anterion determines ACD with CCT plus the aqueous depth (AQD), the axial distance of the posterior cornea to the anterior lens capsule. ACD is not interchangeable between the devices; however, in subgroup analysis, based on ACD at 2.4 mm, the IOL power showed excellent agreement in both subgroups. LAF is another parameter for prediction of tonometric outcomes of PEI for PACD with higher LAF showing better IOP control. Mean LAF was arithmetically different, at 2.18 vs 2.20 mm, between the devices. However, LAF also demonstrated excellent agreement between them.

Limitations of the study

The present study had some limitations. First, we did not grade cataracts with Lens Opacity Classification System (LOCS), so we did not know how much the SS-OCT could penetrate various types of cataract. Second, we applied only Barrett universal II formula, which is commonly used in our practice, for IOL calculation, and it was not able to prove the agreement of EPR with the other formulas. The accuracy of IOL calculation should, therefore, be evaluated by post-operative PEI evaluation. Third, because of the growing popularity of toric IOL implantation, the axis of astigmatism from different devices also needs to be evaluated further.

Conclusion

In conclusion, PACD presenting with small ACD, AL, keratometry and thick lens, was obtained with 2 SS-OCT devices. The biometric measurement performances of the devices were excellent, with low rates of failure. Even though there were some parameters that were arithmetically different between them, they demonstrated excellent agreement of ocular biometry in PACD. Mean difference of AL, a key factor for determination of IOL power, was close to zero. Both devices provided IOL power within an acceptable range, so they can be applied for clinical use with comparable effectiveness.

Raw data of the study.

(XLSX) Click here for additional data file. 28 Feb 2022
PONE-D-21-35600
Evaluation of ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices
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PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ 3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 4. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The authors present a nice study about the biometry in eyes with primary angle-closure disease with 2 SST-OCT devices. The study is interesting because one of the device is new and the study population is different to others previously studied. I only would like to solve some minor issues: 1. Introduction. The authors state that "Primary angle-closure disease (PACD) is the leading cause of blindness worldwide" and cite a paper (reference #1). This paper does not say that. It says that "glaucoma [not PACD] is the leading cause of global irreversible blindness." The authors are mixing reversible and irreversible blindness. And they mix PACD and primary open angle glaucoma (POAG). Please rewrite again the first 4 lines of the introduction. 2. Please write "United States" after every device in which only the state of the USA appears. 3. Please amend "Barrette" and use "Barrett" (lines 245 and 312). Reviewer #2: This is an interesting study which evaluates ocular biometry in primary angle-closure disease (PACD) with two swept source optical coherence tomography devices. This is probably one of the first study comparing these two systems in PACD eyes. This aspect can be highlighted more. Reviewer #3: Dr. Somporn Chantra evaluated ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices. This is meaningful. However, it is advised to calculate the sample size. ********** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.
4 Mar 2022 We have already checked and ensure that our revision manuscript meet the journal requirements (PLOS ONE's style, ORCID ID of corresponding author, supporting information file, and correct references). 5. Review Comments to the Author Reviewer #1: The authors present a nice study about the biometry in eyes with primary angle-closure disease with 2 SST-OCT devices. The study is interesting because one of the device is new and the study population is different to others previously studied. I only would like to solve some minor issues: 1. Introduction. The authors state that "Primary angle-closure disease (PACD) is the leading cause of blindness worldwide" and cite a paper (reference #1). This paper does not say that. It says that "glaucoma [not PACD] is the leading cause of global irreversible blindness." The authors are mixing reversible and irreversible blindness. And they mix PACD and primary open angle glaucoma (POAG). Please rewrite again the first 4 lines of the introduction. Response: Thank you for your comment. We rephrased them as: Primary angle-closure glaucoma (PACG) is one of the leading causes of irreversible blindness worldwide. Its global prevalence is showing an upward trend, and it is expected to reach about 66.8 million cases by 2040. Its prevalence is highest in Asia, and people from this region have the greatest number of cases of blindness resulting from glaucoma.1 Primary angle-closure disease (PACD) is a spectrum of this eye condition, including primary angle-closure suspect (PACS), primary angle-closure (PAC) and PACG. (lines 49-54, page 3) 2. Please write "United States" after every device in which only the state of the USA appears. Response: We added the USA for every device from that country, e.g. IOLMaster700 (Carl Zeiss Meditec, CA, USA), IOL model SN60WF (Alcon, Fort Worth, TX, USA). (line 77, page 4 and line 142, page 7) 3. Please amend "Barrette" and use "Barrett" (lines 245 and 312). Response: We corrected it as your suggestion. (lines 257 and 325) Reviewer #2: This is an interesting study which evaluates ocular biometry in primary angle-closure disease (PACD) with two swept source optical coherence tomography devices. This is probably one of the first study comparing these two systems in PACD eyes. This aspect can be highlighted more. Response: Thank you for your comment. Reviewer #3: Dr. Somporn Chantra evaluated ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices. This is meaningful. However, it is advised to calculate the sample size. Response: We added sample size estimation as: Sample size estimation Sample size calculation was performed using the formula for estimating correlation coefficient with a type I error (α) of 0.05 and type II error (β) of 0.2. The authors estimated the correlation of the devices, using the correlation coefficient (r) of 0.7 for the sample size calculation. The standard normal deviate for α = Zα = 1.9600 The standard normal deviate for β = Zβ = 0.8416 C = 0.5 * ln[(1+r)/(1-r)] = 0.8673 Total sample size = N = [(Zα + Zβ)/C]2 + 3 = 13 The output indicated that at least 13 subjects should be enrolled. And, in the anticipation of a dropout rate of 30%, the minimum sample size required was 17. (lines 119-128, page 6) Submitted filename: Response to the reviewers.docx Click here for additional data file. 9 Mar 2022 Evaluation of ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices PONE-D-21-35600R1 Dear Dr. Chantra, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Aparna Rao Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: 12 Mar 2022 PONE-D-21-35600R1 Evaluation of ocular biometry in primary angle-closure disease with two swept source optical coherence tomography devices Dear Dr. Chantra: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Aparna Rao Academic Editor PLOS ONE
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Review 1.  The definition and classification of glaucoma in prevalence surveys.

Authors:  Paul J Foster; Ralf Buhrmann; Harry A Quigley; Gordon J Johnson
Journal:  Br J Ophthalmol       Date:  2002-02       Impact factor: 4.638

2.  Intraocular lens power calculation for eyes with an axial length greater than 26.0 mm: comparison of formulas and methods.

Authors:  Adi Abulafia; Graham D Barrett; Michael Rotenberg; Guy Kleinmann; Adi Levy; Olga Reitblat; Douglas D Koch; Li Wang; Ehud I Assia
Journal:  J Cataract Refract Surg       Date:  2015-02-21       Impact factor: 3.351

3.  The severity and spatial distribution of visual field defects in primary glaucoma: a comparison of primary open-angle glaucoma and primary angle-closure glaucoma.

Authors:  Gus Gazzard; Paul J Foster; Ananth C Viswanathan; Joe G Devereux; Francis T S Oen; Paul T K Chew; Peng T Khaw; Steve K L Seah
Journal:  Arch Ophthalmol       Date:  2002-12

4.  Ocular biometric repeatability using a new high-resolution swept-source optical coherence tomographer.

Authors:  Ramón Ruíz-Mesa; Salvador Aguilar-Córcoles; Robert Montés-Micó; Pedro Tañá-Rivero
Journal:  Expert Rev Med Devices       Date:  2020-06-11       Impact factor: 3.166

5.  Agreement between 2 swept-source OCT biometers and a Scheimpflug partial coherence interferometer.

Authors:  Pedro Tañá-Rivero; Salvador Aguilar-Córcoles; Cristina Tello-Elordi; Francisco Pastor-Pascual; Robert Montés-Micó
Journal:  J Cataract Refract Surg       Date:  2021-04-01       Impact factor: 3.351

6.  Laser peripheral iridotomy in primary angle-closure suspects: biometric and gonioscopic outcomes: the Liwan Eye Study.

Authors:  Mingguang He; David S Friedman; Jian Ge; Wenyong Huang; Chenjin Jin; Pak Sang Lee; Peng T Khaw; Paul J Foster
Journal:  Ophthalmology       Date:  2006-11-21       Impact factor: 12.079

7.  Repeatability of whole-cornea measurements using a new swept-source optical coherence tomographer.

Authors:  Pedro Tañá-Rivero; Salvador Aguilar-Córcoles; Ramón Ruiz-Mesa; Robert Montés-Micó
Journal:  Eur J Ophthalmol       Date:  2020-07-18       Impact factor: 2.597

8.  Repeatability of automated measurements by a new anterior segment optical coherence tomographer and biometer and agreement with standard devices.

Authors:  Domenico Schiano-Lomoriello; Kenneth J Hoffer; Irene Abicca; Giacomo Savini
Journal:  Sci Rep       Date:  2021-01-13       Impact factor: 4.379

9.  Intradevice Repeatability and Interdevice Agreement of Ocular Biometric Measurements: A Comparison of Two Swept-Source Anterior Segment OCT Devices.

Authors:  Anmol A Pardeshi; Abe E Song; Naim Lazkani; Xiaobin Xie; Alex Huang; Benjamin Y Xu
Journal:  Transl Vis Sci Technol       Date:  2020-08-07       Impact factor: 3.283

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  1 in total

1.  A systemic review and network meta-analysis of accuracy of intraocular lens power calculation formulas in primary angle-closure conditions.

Authors:  Wenhan Lu; Yu Hou; Hongfang Yang; Xinghuai Sun
Journal:  PLoS One       Date:  2022-10-14       Impact factor: 3.752

  1 in total

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