Randomized Prospective Study of Selective Laser Trabeculoplasty (SLT) Versus Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension
NCT01126203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2010-05-24
Summary
Multi-center, prospective, randomized, controlled clinical trial to compare selective laser trabeculoplasty (SLT) and Argon laser trabeculoplasty (ALT) in pseudoexfoliation glaucoma and ocular hypertension patients. IOP will be recorded, at baseline, 6 weeks, 6 months and 1 year after the laser procedure.
Conditions
- Exfoliation Syndrome
- Ocular Hypertension
Interventions
- PROCEDURE
-
SLT
All eyes will be treated using a commercially available Q-switched Nd:YAG laser (Coherent Selecta 7000, Coherent Inc., Palo Alto , CA, USA) calibrated by the manufacturer. On the day of treatment, IOP will be measured, then one drop of Apraclonidine 1% or Brimonidine 0.2% and pilocarpine 1% or 2% will be instilled. Before the patient is seated at the laser slit-lamp system a proparacaine hydrochloride drop will be instilled in the eye to be treated. A Goldmann goniolens or a Latina SLT or any other goniolens will be placed on the eye to be treated with methyl cellulose 1%. The helium-neon aiming beam is focused onto the pigmented trabecular meshwork. SLT will be performed with approximately 50 applications, a 400um spot size with energies varying from 0.8-1.2 mjoules.
- PROCEDURE
-
ALT
All eyes will be treated using Ophthalas 532 Eyelite Laser Photocoagulator (Alcon Surgical, Dallas-Fort Worth, Texas, USA. On the day of treatment, IOP will be measured, then on the day of treatment, IOP will be measured, then one drop of Apraclonidine 1% or Brimonidine 0.2% and pilocarpine 1% will be instilled. Before the patient is seated at the laser slit-lamp system a proparacaine hydrochloride drop will be instilled in the eye to be treated. A Goldmann goniolens will be placed on the eye to be treated with methyl cellulose 1%. The aiming beam is focused onto the anterior portion of the pigmented trabecular meshwork. ALT will be performed to the superior or inferior 180 degrees with \~ 50 applications, a 50um spot size with energies varying from 400-700 mW with 0.1 second duration.
Sponsors & Collaborators
-
Canadian Glaucoma Clinical Research Council
collaborator OTHER -
University of Calgary
lead OTHER
Principal Investigators
-
Andrew C Crichton · University of Calgary
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-09-30
- Completion
- 2009-10-31
Countries
- Canada
Study Locations
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