Topical dorzolamide for macular holes: A randomised, double-blind, placebo-controlled trial

Abstract

Background: To assess topical dorzolamide as medical therapy for idiopathic full-thickness macular holes (FTMHs).

Methods: Randomised, double-blinded, placebo-controlled, single-centre clinical trial involving 32 patients with idiopathic small FTMHs (<400 $\mathrm{\mu m}$ ). Participants in both arms used topical dorzolamide 2% or saline thrice daily for 8 weeks with monthly OCT. Those with persisting FTMH underwent vitrectomy with ILM peel and gas tamponade. The primary outcome was the rate of FTMH closure at the end of treatment.

Results: Between 6 March 2020 and 16 June 2023, 32 eligible patients were enrolled: 16 participants in each arm. All participants in both groups were included in the final analysis. At the final visit, 3 of 16 (18.8%) patients in both the topical dorzolamide and placebo group demonstrated closure. There was no statistically significant difference in the proportion of FTMH closure between the control and treatment group (p = 1.00), nor statistically significant difference in the mean change in best corrected visual acuity (BCVA; p = 0.909). There was no difference in the change in FTMH diameter between groups (p = 0.225). No serious adverse events were reported in either group.

Conclusion: Topical dorzolamide was safe but not superior to placebo in the functional and anatomical outcomes of FTMH.

Keywords: clinical trial; macular hole; placebo; topical dorzolamide.