Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
Information source: Walter Reed Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: brimonidine 0.1% (Drug); Apraclonidine 0.5% (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Walter Reed Army Medical Center Official(s) and/or principal investigator(s):
Vladimir S Yakopson, MD, Principal Investigator, Affiliation: Walter Reed AMC
Overall contact:
Vladimir S Yakopson, MD, Phone: 202-782-6965, Email: vladimir.yakopson@na.amedd.army.mil
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.
Clinical Details
Official title: Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Postoperative IOP
Secondary outcome: Overall IOP reduction post 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Vladimir S Yakopson, MD, Phone: 202-782-6965, Email: vladimir.yakopson@na.amedd.army.mil
Walter Reed Army Medical Center, Washington, District of Columbia 20307, United States; Recruiting
Vladimir S Yakopson, MD, Phone: 202-782-6965, Email: vladimir.yakopson@na.amedd.army.mil
William Wilson, MD, Sub-Investigator
Additional Information
Starting date: August 2006
Last updated: December 4, 2007
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