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Steroids After Laser Trabeculoplasty for Glaucoma (SALT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 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: May 26, 2013
Last verified: May 2013
  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:


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 2015
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 26, 2013
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
Eye Diseases
Ocular Hypertension
Anti-Inflammatory Agents
Diclofenac
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Ophthalmic Solutions
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents

ClinicalTrials.gov processed this record on November 25, 2014