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Steroids After Laser Trabeculoplasty for Glaucoma (SALT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981435
First Posted: September 22, 2009
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bascom Palmer Eye Institute
University of Pittsburgh
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University
  Purpose
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 Intervention Phase
Glaucoma Drug: Prednisolone 1% Drug: Diclofenac 0.1% Drug: Artificial Tears Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jeffrey L Goldberg, Stanford University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 97
Study Start Date: September 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

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


Locations
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
Investigators
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 Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: December 28, 2016
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:
Glaucoma
Trabeculoplasty
Selective laser trabeculoplasty
Intraocular pressure

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