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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
brimonidine 0.1%
Apraclonidine 0.5%
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

I

A

Arm Description

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Outcomes

Primary Outcome Measures

Postoperative IOP

Secondary Outcome Measures

Overall IOP reduction post SLT

Full Information

First Posted
December 4, 2007
Last Updated
December 4, 2007
Sponsor
Walter Reed Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00567411
Brief Title
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
Official Title
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Walter Reed Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT
Arm Title
A
Arm Type
Active Comparator
Arm Description
Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT
Intervention Type
Drug
Intervention Name(s)
brimonidine 0.1%
Intervention Description
1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
Intervention Type
Drug
Intervention Name(s)
Apraclonidine 0.5%
Intervention Description
1 drop applied 1 hour prior to SLT
Primary Outcome Measure Information:
Title
Postoperative IOP
Time Frame
1 hour and 1 week post surgery
Secondary Outcome Measure Information:
Title
Overall IOP reduction post SLT
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir S Yakopson, MD
Phone
202-782-6965
Email
vladimir.yakopson@na.amedd.army.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir S Yakopson, MD
Organizational Affiliation
Walter Reed AMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir S Yakopson, MD
Phone
202-782-6965
Email
vladimir.yakopson@na.amedd.army.mil
First Name & Middle Initial & Last Name & Degree
William Wilson, MD

12. IPD Sharing Statement

Learn more about this trial

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

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