Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure
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.
Interventions
DRUGbrimonidine 0.1%
1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
DRUGApraclonidine 0.5%
1 drop applied 1 hour prior to SLT
Sponsors
Walter Reed Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative IOP | 1 hour and 1 week post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Overall IOP reduction post SLT | 1 month |
Countries
United States
Contacts
Primary ContactVladimir S Yakopson, MD
Outcome results
None listed