Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma

Abstract

IntroductionTo demonstrate that preoperative treatment for 28 days with topical dorzolamide/timolol is non-inferior (Δ = 4 mm Hg) to oral acetazolamide and topical dexamethasone (standard therapy) in terms of intraocular pressure (IOP) reduction 3 and 6 months after trabeculectomy in glaucoma patients.Materials and methodsSixty-two eyes undergoing trabeculectomy with mitomycin C were included in this monocentric prospective randomized controlled study. IOP change between baseline and 3 months post-op was defined as the primary efficacy variable. Secondary efficacy variables included the number of 5-fluorouracil (5-FU) injections, needlings, suture lyses, preoperative IOP change, hypertension rate and change of conjunctival redness 3 and 6 months post-op. Safety was assessed based on the documentation of adverse events.ResultsPreoperative treatment with topical dorzolamide/timolol was non-inferior to oral acetazolamide and topical dexamethasone in terms of IOP reduction 3 months after trabeculectomy (adjusted means -8.12 mmHg versus -8.30 mmHg; Difference: 0.18; 95% CI -1.91 to 2.26, p = 0.8662). Similar results were found 6 months after trabeculectomy (-9.13 mmHg versus -9.06 mmHg; p = 0.9401). Comparable results were also shown for both groups concerning the classification of the filtering bleb, corneal staining, and numbers of treatments with 5-FU, needlings and suture lyses. More patients reported AEs in the acetazolamide/dexamethasone group than in the dorzolamide/timolol group.DiscussionPreoperative, preservative-free, fixed-dose dorzolamide/timolol seems to be equally effective as preoperative acetazolamide and dexamethasone and has a favourable safety profile.

First-in-human phase I study of ISTH0036, an antisense oligonucleotide selectively targeting transforming growth factor beta 2 (TGF-β2), in subjects with open-angle glaucoma undergoing glaucoma filtration surgery

“…For bleb filtering and bleb morphology there was overall a trend for increase in bleb score over time (except for DL 2; see Table 5 for details). In line with prior observations for trabeculectomy best corrected visual acuity (BCVA) worsened moderately in all patients at all dose levels for the observation period ( Table 6 ), as described in other trabeculectomy outcome analyses, too [ 27 ].…”

“…Glaucoma continues to be a threat to visual function for millions of patients worldwide. Despite multiple medical treatment options, in the US alone more than 120.000 patients have turned bilaterally blind from glaucoma, representing 1/10 of all cases [ 27 ]. So far, the pathophysiology and underlying molecular mechanisms of glaucoma have not been fully understood [ 28 ].…”

Preparing the ocular surface for glaucoma filtration surgery: an unmet clinical need

“…To date, dexamethasone, the most potent steroid, was evaluated only in the study of Lorenz et al. (2017), where topical dexamethasone was administrated one week before surgery five times daily. The authors reported a significant IOP increase the day before surgery, with baseline values increasing by 40% (from 19.7 to 27.6 mmHg).…”

Dorzolamide/Timolol Fixed Combination: Learning from the Past and Looking Toward the Future

“…In a recent 24-h investigation it has been shown that the IOP-lowering effect of PF DTFC administered twice daily is additive to that of PF tafluprost administered once in the evening [ 40 ]. Finally, PF DTFC has been successfully tried for controlling IOP for 3 months temporizing before planned glaucoma filtration surgery, an intervention for which the preservative related ocular irritation may have a negative effect on surgical success [ 43 ].…”