Background/aims To evaluate the success of Mitomycin C (MMC) augmented trabeculectomy with or without intravitreal bevacizumab in patients with diabetes without neovascular glaucoma.
Methods Fifty-six patients with diabetes who needed trabeculectomy were randomised to either combination of 2.5 mg intravitreal bevacizumab and subconjunctival MMC (group A, 28 eyes) or subconjunctival MMC alone (group B, 28 eyes). The main outcome measures were intraocular pressure (IOP), number of antiglaucoma medications, bleb morphology and success probability. Surgical success was defined as complete according to two levels of IOP (≤18 and <15 mm Hg) and at least 20% reduction from preoperative IOP without antiglaucoma medications and qualified as complete success but with antiglaucoma medications. Total success was the sum of complete and qualified success.
Results The mean age was 65.2±12.9 and 67.4±10.2 years in groups A and B, respectively (p=0.50). All patients completed at least 1 year of follow-up. The mean 1-year IOP decreased from 25.2±12.0 mm Hg to 10.1±2.8 in group A and from 26.4±11.6 mm Hg to 15.2±6.9 in group B (all p<0.001). Overall, postoperative IOP measurement was statistically significantly lower in group A at month 12 (p=0.001). The number of medications in groups A and B at month 12 was 0.3±0.8 and 1.0±1.2, respectively (p=0.02). The cumulative probability of success at month 12 was not statistically significant (89.3% group A, 78.6% group B; p=0.27).
Conclusion In patients with diabetes with primary trabeculectomy, combined administration of intravitreal bevacizumab and subconjunctival MMC resulted in lower IOP and number of antiglaucoma medication compared with subconjunctival MMC alone.
- clinical trial
- intraocular pressure
- treatment surgery
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Contributors NN: main idea, supervision, clinical implementation, manuscript review, revision. AE: data gathering, writing of manuscript. AM: clinical implementation, supervision. NA: data gathering, data analysis, writing of manuscript, revision. MB: data analysis.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The ethics committee of the Iran University of the Medical Sciences approved the study protocol.
Data availability statement Data are available upon reasonable request. Deidentified participant data may be available on reasonable request.