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Steroids After Laser Trabeculoplasty for Glaucoma (SALT)

This study is currently recruiting participants.
Verified July 2012 by University of Miami
Sponsor:
Collaborators:
Bascom Palmer Eye Institute
University of Pittsburgh
Information provided by (Responsible Party):
Jeffrey L. Goldberg, University of Miami
ClinicalTrials.gov Identifier:
NCT00981435
First received: September 21, 2009
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Intraocular pressure (IOP) lowering [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
    IOP will be measured before and at 6 and 12 weeks after intervention.


Secondary Outcome Measures:
  • Intraocular inflammation [ Time Frame: 1-12 weeks ] [ Designated as safety issue: Yes ]
    The number of patients with persistent inflammation will be measured in each study arm.


Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artificial Tears Drug: Artificial Tears
Artificial saline tears to lasered eye 4 times/day for 4.5 days
Experimental: Non-steroidal anti-inflammatory Drug: Diclofenac 0.1%
Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
Experimental: Steroid Drug: Prednisolone 1%
Prednisolone 1% to lasered eye 4 times/day for 4.5 days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981435

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Jeffrey L. Goldberg, MD, PhD     305-547-3720     BascomPalmerEyeTrials@gmail.com    
Principal Investigator: Jeffrey L Goldberg, MD, PhD            
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Eiyass Albeiruti, MD     412-647-8199        
Principal Investigator: Eiyass Albeiruti, MD            
Sponsors and Collaborators
University of Miami
Bascom Palmer Eye Institute
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Jeffrey L. Goldberg, Associate Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT00981435     History of Changes
Other Study ID Numbers: 20081142
Study First Received: September 21, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Glaucoma
Trabeculoplasty
Selective laser trabeculoplasty
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Anti-Inflammatory Agents
Diclofenac
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013