Steroids After Laser Trabeculoplasty for Glaucoma

NCT ID: NCT00981435

Last Updated: 2019-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Artificial Tears

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

Group Type EXPERIMENTAL

Artificial Tears

Intervention Type DRUG

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

Non-steroidal anti-inflammatory

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Steroid

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

Group Type EXPERIMENTAL

Prednisolone 1%

Intervention Type DRUG

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

Interventions

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Prednisolone 1%

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

Intervention Type DRUG

Ketorolac

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

Intervention Type DRUG

Artificial Tears

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

Intervention Type DRUG

Other Intervention Names

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Pred forte Voltaren saline tears

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bascom Palmer Eye Institute

OTHER

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey L Goldberg

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey L Goldberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20081142

Identifier Type: -

Identifier Source: org_study_id

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