| Literature DB >> 35134078 |
Takashi Kumanomido1, Kazutaka Kamiya2, Masahide Takahashi1, Tatsuhiko Tsujisawa1, Hideki Hayakawa1, Wakako Ando1, Yoshikazu Utsumi1, Nobuyuki Shoji1.
Abstract
Aspherical- and multi-curve rigid gas-permeable hard contact lenses (HCLs) have a flattened curve in the peripheral zone and are mostly used for patients with keratoconus who cannot wear glasses, soft contact lenses, or spherical HCLs. In this retrospective study, a total of 95 eyes of 77 patients who used aspherical- or multi-curve HCLs (mean age: 40.0 ± 11.0 years) were evaluated. This study examined the types of aspherical- and multi-curve HCLs, best-corrected visual acuity (BCVA) values before and after wearing HCLs, the association with the Amsler-Krumeich classification, duration of wear, corneal/conjunctival disorder, and the frequency of changing HCLs. There were 78 eyes that used aspherical-curve HCLs and 17 that used multi-curve HCLs. BCVA significantly improved from 0.42 logMAR to 0.06 logMAR after wearing either form of HCL. The Amsler-Krumeich classification showed that aspherical-curve HCLs were commonly used for patients with stage 2 keratoconus, and multi-curve HCLs were commonly used for stage 4 patients. The BCVA values were worse when the disease stage was more severe (stages 3 and 4) regardless of HCL type. The mean base curve of the lenses was steeper in multi-curve HCLs than in aspherical-curve HCLs. The more severe the disease stage, the steeper the base curve in both aspherical- and multi-curve HCLs. The duration of wear significantly improved from 2.1 h to 10.2 h, and corneal/conjunctival disorder similarly improved. The mean frequency of changing HCL types was 1.1 times. This study suggests that a flat peripheral curve design with aspherical- and multi-curve HCLs is useful for patients with keratoconus.Entities:
Mesh:
Year: 2022 PMID: 35134078 PMCID: PMC8824338 DOI: 10.1371/journal.pone.0263506
Source DB: PubMed Journal: PLoS One ISSN: 1932-6203 Impact factor: 3.240
Fig 1Rigid gas-permeable hard contact lens (HCL) design.
Specifications of rigid gas-permeable hard contact lenses.
| Aspherical curve HCL | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E3 type | E4 type | E5 type | ||||||||||
|
| 5.0 | 5.0 | 6.0 | |||||||||
|
| 6.00–8.70 | 5.50–8.70 | 6.0–8.70 | |||||||||
|
| 9.6 | 9.6 | 9.8 | |||||||||
|
| 60 ×10−11(cm2/s)∙(mL O2/(mL × mmHg) | |||||||||||
|
| -20.00 to +20.00 (0.25 D step) | |||||||||||
|
| ||||||||||||
| OZD, mm | BC, mm | 2nd curve, mm | 3rd curve, mm | 4th curve, mm | Bevel, mm | Lens size, mm | ||||||
|
|
| 6.0 | 5.00–8.00 | BC +0.5 | BC +1.0 | 0.60 | 8.8 | |||||
|
| 6.0 | 5.00–7.00 | BC +0.5 | BC +1.0 | 0.70 | 8.8 | ||||||
|
| 6.0 | 5.00–6.90 | BC +1.0 | BC +1.5 | 0.70 | 9.0 | ||||||
|
|
| 5.5 | 5.00–8.00 | BC +0.5 | BC +1.0 | BC +1.5 | 0.45 | 8.8 | ||||
|
| 5.5 | 5.00–7.00 | BC +1.0 | BC +1.5 | BC +1.5 | 0.70 | 8.8 | |||||
|
| 60 ×10−11(cm2/s)∙(mL O2/(mL × mmHg) | |||||||||||
|
| 0 to—20.00 (0.25 D step) | |||||||||||
E, eccentricity; OZD, optical zone diameter; BC, base curve; Dk, oxygen permeability: (diffusion coefficient) × (solubility); D, diopter.
Patient demographics of the study population.
| All | Aspherical-curve HCL | Spherical multi-curve HCL | p | |
|---|---|---|---|---|
|
| 95 | 78 | 17 | |
|
| 65:30 | 55:23 | 10:7 | 0.238 |
|
| 40.0 ± 11.0 | 40.1 ± 13.8 | 38.1 ± 11.2 | 0.632 |
|
| 17–71 | 17–71 | 20–58 | |
|
| 19.7 ± 7.9 | 17.5 ± 8.8 | 21.0 ± 7.1 | 0.654 |
|
| 0.06 ± 0.16 | 0.06 ± 0.13 | 0.05 ± 0.06 | 0.943 |
|
| 6.59 ± 0.6 | 7.20 ± 0.5 | 6.13 ± 0.4 | <0.001 |
|
| 10.1 ± 3.7 | 10.2 ± 3.7 | 11.3 ± 3.1 | 0.562 |
|
| (2.1 ± 4.2) | (2.1 ± 4.0) | (2.2 ± 5.2) | 0.016 |
|
| 58.1 ± 4.4 | 57.3 ± 4.8 | 62.5 ± 5.5 | <0.001 |
|
| 4.6 ± 3.2 | 4.6 ± 3.5 | 4.7 ± 1.2 | 0.284 |
|
| 473.3 ± 68.7 | 479.5 ± 68.9 | 440.2 ± 60.1 | 0.454 |
|
| 433.0 ± 82.2 | 445.6 ± 79.1 | 360.2 ± 70.5 | 0.002 |
HCL, hard contact lens; BCVA, best-corrected visual acuity; logMAR, logarithm of the minimum angle of resolution; D, diopter.
Best-corrected visual acuity for aspherical- and spherical multi-curve hard contact lenses according to the Amsler-Krumeich classification.
| Stage | p | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
|
| 0.006 ± 0.13 | 0.02 ± 0.05 | 0.09 ± 0.11 | 0.14 ± 0.20 | 0.017 (ANOVA) |
| 1 | 2 | 3 | 4 | ||
|
| No wear | 0.02 ± 0.06 | 0 | 0.13 ± 0.12 | <0.001 (Stage 2 vs. 4, Mann-Whitney U test) |
ANOVA, analysis of variance; HCL, hard contact lens.
Types of aspherical- and spherical multi-curve hard contact lenses used for keratoconus.
| Lens type | Cases / eyes | |
|---|---|---|
|
| E3 | 3 / 4 |
| E4 | 50 / 65 | |
| E5 | 8 / 9 | |
|
| 3-level normal | 4 / 4 |
| 3-level steep | 1 / 2 | |
| 3-level flat | 3 / 3 | |
| 4-level normal | 2 / 2 | |
| 4-level steep | 6 / 6 | |
|
| 77 / 95 |
HCL, hard contact lens; E, eccentricity.
Lens base curves of aspherical- and spherical multi-curve HCLs according to the Amsler-Krumeich classification.
| Stage | p-value | |||||
|---|---|---|---|---|---|---|
|
| 1 | 2 | 3 | 4 | ||
|
| 7.4 ± 0.4 | 7.2 ± 0.3 | 7.1 ± 0.4 | 6.9 ± 0.5 | <0.001 (ANOVA) | |
|
| 1 | 2 | 3 | 4 | ||
| No wear | 6.2 ± 0.3 | 6.9 | 6.0 ± 0.3 | <0.001 (Stage 2 vs. 4, Mann-Whitney U test) | ||
ANOVA, analysis of variance; BC, base curve; HCL, hard contact lens.
Corneal shape parameters in the aspherical- and spherical multi-curve HCL groups at the final follow-up.
| All | Aspherical-curve HCL | Spherical multi-curve HCL | p | |
|---|---|---|---|---|
|
| 52.5 ± 7.7 | 51.1 ± 6.8 | 62.4 ± 5.9 | 0.002 |
|
| 4.9 ± 3.9 | 4.7 ± 3.3 | 6.7 ± 7.0 | 0.769 |
|
| 474.3 ± 63.3 | 479.8 ± 63.0 | 434.9 ± 54.4 | 0.309 |
|
| 435.8 ± 78.7 | 447.0 ± 69.3 | 348.1 ± 92.6 | 0.005 |
HCL, hard contact lens; D, diopter.
Previous studies on aspherical-curve rigid gas-permeable hard contact lens for keratoconus.
| Current. | Yanai et al. (2010) | Kazanci et al. (2014) | |
|---|---|---|---|
|
| Aspherical tri-curve (HI SANSOα Aspherical lens®) | Aspherical tri-curve (Aphex KC®) | Aspherical (Boston Eqalens®) (Boston7®)(CFKE®) |
|
| 60 × 10−11 | 61.3 × 10−9 (Dk/t) | Not listed |
|
| 5.0–6.0 | 5–7 | Not listed |
|
| 9.6–9.8 | 8.4–9.6 | Not listed |
|
| Optical zone: E 0 | Optical zone: E 0.4–0.45 | Not listed |
| Peripheral zone: E 3,4,5 | Peripheral zone: E 0.6 | ||
|
| 78 | 29 | 155 |
|
| 17.5 ± 8.8 | 40.9 ± 19.7 | 12 |
|
| 0.06 ± 0.13 | 0.2 better | 0.75–0.8 (median) (decimal) |
|
| 10.2 ± 3.7 | 12.6 ± 3.2 | Boston Eqalens® |
| 8.0 ± 1.39 | |||
| Boston7® | |||
| 7.9 ± 1.19 | |||
| CFKE® | |||
| 8.7 ± 2.2 | |||
|
| 98.7% | 86.2% | Not listed |
|
| Stage 1, 13 eyes | <45 D, 5 eyes | <45 D, 0 eye |
| Stage 2, 30 eyes | 45≤, <52 D, 10 eyes | 45≤, <52 D, 92 eyes | |
| Stage 3, 12 eyes | 52≤, <62 D, 7 eyes | 52≤, <62 D, 57 eyes | |
| Stage 4, 18 eyes | ≥62 D, 7 eyes | >62 D, 4 eyes | |
| Not classified, 5 eyes | (Mean K) | (Mean K) |
Dk, (diffusion coefficient) × (solubility) (cm2/s) (mL O2/ (mL × mmHg); t, thickness (cm), E, eccentricity; D, diopter; logMAR, logarithm of the minimum angle of resolution; Mean K, mean keratometry.
Summary of previous studies on multi-curve rigid gas-permeable hard contact lens for keratoconus.
| Current | Yanai et al. (2013) | Kazanci et al. (2014) | Lee et al. (2004) | |
|---|---|---|---|---|
|
| Multi-curve (HI SANSOα Multi-curve lens®) | Multi-curve (TwinbelⅡ®) | Multi-curve (Rose K®) | Multi-curve (YK Lens®) |
|
| 60 × 10−11 | 12.1 × 10−11 | 100 × 10−11 | 47 × 10−11 |
|
| 5.5–6.0 | 7.0–8.0 | Not listed | Not listed |
|
| 8.8–9.0 | 8.5–10.0 | Not listed | 8.7 |
|
| 2nd BC + 0.5 | BC +0.3–0.7 | Not listed | 2nd BC + 0.2 |
| 3rd BC + 1.0, 1.5 | 3rd BC + 0.4 | |||
| 4th BC + 1.5 | 4th BC + 0.6 | |||
|
| 17 | 9 | 74 | 72 |
|
| 21.0 ± 7.21 | 13.3 ± 1.4 | 12 | 11.4 |
|
| 0.05 ± 0.06 | 0.01 ± 0.40 | 0.8 (median) (decimal) | 20/30 |
|
| 11.3 ± 3.1 | 12.6 ± 3.2 | 9.7 ± 0.88 | 11.9 |
|
| 82.3% | 100% | Not listed | 95% |
|
| Stage 1, 0 eye | <45 D, | <45 D, | 47.6 ± 4.5 D |
| Stage 2, 3 eyes | 4 eyes | 0 eye | (Max K) | |
| Stage 3, 1 eye | 45≤, <52 D, | 45≤, <52 D, | ||
| Stage 4, 10 eyes | 1 eye | 42 eyes | ||
| Not classified, 3 eyes | 52≤, <62 D, | 52≤, <62 D, | ||
| 3 eyes | 31 eyes | |||
| >62 D, | >62 D, | |||
| 1 eye | 1 eye | |||
| (Mean K) | (Mean K) |
Dk, (diffusion coefficient) × (solubility): (cm2/s) (mL O2/(mL × mmHg); logMAR, logarithm of the minimum angle of resolution; D, diopter; Mean K, mean keratometry; Max K, maximum keratometry.