Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

December 4, 2007 updated by: Walter Reed Army Medical Center
The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Recruiting
        • Walter Reed Army Medical Center
        • Contact:
        • Sub-Investigator:
          • William Wilson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female, at least 18 years of age
  • Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
  • Ocular Hypertension requiring lowering of IOP
  • ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

  • inability to understand and provide informed consent to participate in this study
  • inability/unwillingness to follow study instructions and complete all required visits
  • Documented allergy to either brimonidine or iopidine
  • Angle Closure Glaucoma
  • Congenital/Juvenile Glaucoma
  • Neovascular Glaucoma
  • Active uveitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT
Drug: Apraclonidine 0.5%
1 drop applied 1 hour prior to SLT
Active Comparator: A
Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT
Drug: brimonidine 0.1%
1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative IOP
Time Frame: 1 hour and 1 week post surgery
1 hour and 1 week post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall IOP reduction post SLT
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Medical Center

Investigators

  • Principal Investigator: Vladimir S Yakopson, MD, Walter Reed AMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 4, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAMC WU # 06-23016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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