Steroids After Laser Trabeculoplasty for Glaucoma - Full Text View

Sponsor:	University of Miami
Collaborators:	Bascom Palmer Eye Institute University of Pittsburgh
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00981435

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 IV

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 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, University of Miami, Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:	NCT00981435 History of Changes
Other Study ID Numbers:	20081142
Study First Received:	September 21, 2009
Last Updated:	August 8, 2011
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 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
Antiemetics

ClinicalTrials.gov processed this record on February 09, 2012