CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Prostaglandinsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03292796
NCT03292796Phase 2Completed

A Randomised Control Study to Investigate if the Continuation of Prostaglandin Analogue Treatments in the Post-operative Phase of Glaucoma Patients Undergoing Cataract Surgery Increases the Incidence of Cystoid Macular Oedema.

Julie Dawson·interventional·Posted Sep 26, 2017·Updated Oct 8, 2020

In Brief

A Phase 2 clinical trial evaluating Prostaglandins for Open Angle Glaucoma and Cataract. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss following routine cataract surgery. This complication is more prevalent in eyes with excessive inflammation as they heal from surgery. Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high pressure in the eye. Prostaglandins are inflammatory mediators. In the post-operative care of glaucoma patients undergoing cataract surgery, there is a clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical practice is completely dichotomized between continuing and stopping PGA treatment in the postoperative period. There is conflicting scientific literature on the effect of PGA on the incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999, 117:34-40), where the post operative regime is not applicable to present practice, compared the incidence of CMO following routine cataract surgery in POAG on PGA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 26, 2017
Enrollment StartDec 7, 2016
Primary CompletionOct 21, 2019
Study CompletionJul 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.8 years ago

Interventions

Prostaglandinsdrug