Steroids After Laser Trabeculoplasty for Glaucoma

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Artificial Tears; Drug: Prednisolone 1%; Drug: Ketorolac

• Registration Number: NCT00981435
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

Detailed Description

SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-12-28
• Results First Submitted QC: 2017-02-28
• Results First Posted: 2017-04-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• clinical diagnosis of glaucoma
• clinician has determined that SLT laser is indicated
• IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

Exclusion Criteria

• prior history of uveitis
• prior glaucoma surgery including glaucoma laser surgery
• pregnant or 3 months post-partum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial Tears	Artificial Tears	Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Steroid	Prednisolone 1%	Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Non-steroidal anti-inflammatory	Ketorolac	Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) Change	Baseline to Week 12	IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.

Secondary Outcome Measures

Name	Time	Method
Intraocular Inflammation	Up to week 12	The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.

Trial Locations

Locations (2)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States