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Steroids After Laser Trabeculoplasty for Glaucoma (SALT)

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ClinicalTrials.gov Identifier: NCT00981435
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Prednisolone 1% Drug: Diclofenac 0.1% Drug: Artificial Tears Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
Study Start Date : September 2009
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Artificial Tears
Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Drug: Artificial Tears
Artificial saline tears to lasered eye 4 times/day for 4.5 days
Other Name: saline tears
Experimental: Non-steroidal anti-inflammatory
Topical diclofenac 0.1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Drug: Diclofenac 0.1%
Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
Other Name: Voltaren
Experimental: Steroid
Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.
Drug: Prednisolone 1%
Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Other Name: Pred forte

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981435

United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Stanford University
Bascom Palmer Eye Institute
University of Pittsburgh
Principal Investigator: Jeffrey L Goldberg, MD, PhD Stanford University
More Information

Responsible Party: Jeffrey L Goldberg, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT00981435     History of Changes
Other Study ID Numbers: 20081142
First Posted: September 22, 2009    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is anticipated to be shared upon publication of results.

Keywords provided by Jeffrey L Goldberg, Stanford University:
Selective laser trabeculoplasty
Intraocular pressure

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Lubricant Eye Drops
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents