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Completed

NCT Number: NCT00981435

Steroids After Laser Trabeculoplasty for Glaucoma

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).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bascom Palmer Eye Institute, Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone 1%

Drug

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

Other names: Pred forte

Ketorolac

Drug

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

Other names: Voltaren

Artificial Tears

Drug

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

Other names: saline tears

Primary outcomes

  1. Intraocular Pressure (IOP) Change

    Time frame: Baseline to Week 12

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

Secondary outcomes

  1. Intraocular Inflammation

    Time frame: Up to week 12

    The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Bascom Palmer Eye Institute
  • University of Pittsburgh Medical Center

Registry information

Official study title

Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT

Acronym: SALT

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2009
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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