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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00567411
First received: December 4, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Glaucoma
Ocular Hypertension
Drug: brimonidine 0.1%
Drug: Apraclonidine 0.5%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Postoperative IOP [ Time Frame: 1 hour and 1 week post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall IOP reduction post SLT [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: August 2006
Estimated Study Completion Date: June 2009
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00567411

Contacts
Contact: Vladimir S Yakopson, MD 202-782-6965 vladimir.yakopson@na.amedd.army.mil

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Vladimir S Yakopson, MD    202-782-6965    vladimir.yakopson@na.amedd.army.mil   
Sub-Investigator: William Wilson, MD         
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Vladimir S Yakopson, MD Walter Reed AMC
  More Information

No publications provided

Responsible Party: Vladimir S Yakopson, MD, Ophthalmology Service, Department of Surgery, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00567411     History of Changes
Other Study ID Numbers: WRAMC WU # 06-23016
Study First Received: December 4, 2007
Last Updated: December 4, 2007
Health Authority: United States: Federal Government
United States: Human Use Committee

Keywords provided by Walter Reed Army Medical Center:
Glaucoma
Laser
laser trabeculoplasty
selective laser trabeculoplasty
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Apraclonidine
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014