Rathika Kandasamy 1 , Marios Constantinou 1 , Sophie L Rogers 1 , Sukhpal Singh Sandhu 1 , Sanjeewa Wickremasinghe 1 , Salmaan Al-Qureshi 1 , Lyndell L Lim 2 Show Affiliations »
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AIM: To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB ) 1.25 mg versus triamcinolone acetonide (TA ) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO ). METHODS: Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior ) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT ) from baseline to the 6-month time point of this 12-month study. RESULTS: 61 eyes of 58 patients were enrolled . At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04). CONCLUSIONS: When given as an adjunct to cataract surgery , both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
RCT Entities: Population
Interventions
Outcomes
AIM: To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB ) 1.25 mg versus triamcinolone acetonide (TA ) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO ). METHODS: Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT ) from baseline to the 6-month time point of this 12-month study. RESULTS: 61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04). CONCLUSIONS: When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT , with the majority not requiring any further treatment postoperatively. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
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Keywords:
bevacizumab; cataract surgery; diabetic macular oedema; randomised clinical trial; triamcinolone
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Year: 2019
PMID： 30819688 DOI： 10.1136/bjophthalmol-2018-313437
Source DB: PubMed Journal: Br J Ophthalmol ISSN： 0007-1161 Impact factor: 4.638