Steroids After Laser Trabeculoplasty for Glaucoma

NCT00981435 | Completed Phase 4 Results

• 1 other identifier: 20081142
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

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).

Conditions

Glaucoma

Keywords

Glaucoma; Trabeculoplasty; Selective laser trabeculoplasty; Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) Change

  IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.

  Baseline to Week 12

Secondary Outcomes (1)

• Intraocular Inflammation

  Up to week 12

Study Arms (3)

Artificial Tears

EXPERIMENTAL

Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Drug: Artificial Tears

Non-steroidal anti-inflammatory

EXPERIMENTAL

Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Drug: Ketorolac

Steroid

EXPERIMENTAL

Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.

Drug: Prednisolone 1%

Interventions

Prednisolone 1% DRUG

Prednisolone 1% to lasered eye 4 times/day for 4.5 days

Also known as: Pred forte

Steroid

Ketorolac DRUG

Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days

Also known as: Voltaren

Non-steroidal anti-inflammatory

Artificial Tears DRUG

Artificial saline tears to lasered eye 4 times/day for 4.5 days

Also known as: saline tears

Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Bascom Palmer Eye Institute: collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (2)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone; prednisolone acetate; Ketorolac; Diclofenac; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Stanford University

mnunez1@stanford.edu

6507236995

Study Officials

• Jeffrey L Goldberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 7, 2019
• Results First Posted: April 14, 2017

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)