Effect of Latanaprost eye drop on retina after cataract surgery in glaucoma patients

Phase 2

Conditions: Cystoid macular edema.
Other specified retinal disorders
H35.8

Registration Number: IRCT2016081329326N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Purpose To evaluate the effect of postoperative latanoprost administration on central macular thickness (CMT) after uneventful cataract surgery in glaucoma patients. Setting Farabi Eye Hospital, Tehran, Iran. Design Prospective randomized clinical trial. Methods In this single-masked trial, glaucoma patients treated with latanoprost who had no other risk factor for the development of pseudophakic macular edema were randomly allocated to continuation of latanoprost or discontinuation of the drop after uneventful cataract surgery. At baseline and postoperatively at 1 month and 3 months, patients had complete ocular examinations and CMT measurements using optical coherence tomography. The main outcome measure was the change in the CMT between baseline measurements and postoperative measurements at 1 month and 3 months. Results One hundred fifty-six eyes (latanoprost 76; discontinuation 80) finished the trial. There were no differences in baseline patient demographics or characteristics, including the CMT, between the two groups. There was transient increase in the mean CMT by 12 µm ± 49 (SD) in the latanoprost group at 1 month (P = .03); however, the value returned to baseline by 3 months (6 ± 55 µm; P = .27). The between-group difference in the mean change in the CMT from baseline was -3.1 µm (95% confidence interval [CI], -18.4 to 12.0; P = .68) after 1 month and -10.5 µm (95% CI, -26.6 to 5.5; P = .19) after 3 months; the differences were not significant. Conclusion Latanoprost administration after cataract surgery had no measurable effect on macular thickness.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 166

Inclusion Criteria

Glaucoma patients with 18 years old or more
Treating with topical latanoprost 0.005% eye drop at least for 6 months with or without other antiglaucoma topical agents
Who needed cataract surgery (phacoemulsification)

Exclusion Criteria

History of any intraocular surgery, intravitreal injections, or retinal laser
History of trauma
Non-glaucomatous optic neuropathy
High myopia
History of diabetic retinopathy, any age-related macular degeneration (AMD), uveitis, retinal detachment (RD), epiretinal membrane (ERM), and retinal vascular disorders
An occurrence of CME in the fellow eye following previous cataract surgery
Recent history of NSAID therapy (topical or oral)
Any abnormality in fundus examination except for glaucomatous changes
Any abnormality in pre-operative macular OCT.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Macular Thickness. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Using OCT-SD imaging.

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Goldmann tonometry.;Visual acuity. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Snellen chart.;Number of medications needed to control the IOP. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Medical records.;Incidence of clinical cystoid macular edema. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Clinical Fundus examination.;Incidence of significant increase in CMT. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Defined as = 50 µm compared to the baseline in OCT imaging.