Randomized Prospective Study of Selective Laser Trabeculoplasty (SLT) Versus Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension

This study has been completed.
Sponsor:
Collaborator:
Canadian Glaucoma Clinical Research Council
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01126203
First received: May 17, 2010
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Exfoliation Syndrome
Ocular Hypertension
Procedure: SLT
Procedure: ALT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicentre Prospective Study of Selective Laser Trabeculoplasty (SLT) vs. Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • IOP (Intraocular Pressure) [ Time Frame: 1 hour, 6 weeks, 3, 6 &12 months ] [ Designated as safety issue: No ]
    The main primary outcome variable will be the intraocular pressures (IOP) at 1 hour, 6 weeks, 3, 6 & 12 months post-operatively


Enrollment: 25
Study Start Date: September 2006
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: selective laser trabeculoplasty (SLT) 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.
Experimental: Argon laser trabeculoplasty (ALT) 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.

Detailed Description:

This study derives from a clinical observation that laser treated eyed with PXF glaucoma may have a similar long-term response rates when either ALT or SLT is performed. Some authors have considered that there is a risk of IOP elevation in the immediate post laser period with ALT or SLT as a complication to be related to denser angle pigmentation (20,48). (46) No long-term analysis comparing response rates of both laser treatments in these types of patients has been done.

Primary objective is to determine which laser therapy has more IOP lowering effect as primary or adjunctive treatment in eyes diagnosed with ocular hypertension and glaucoma associated to PXF. Response rates will be compared between groups at long-term.

Secondary objective is to determine the relationship between the type of laser therapy performed and angle pigmentation, number of applications, and amount of energy used with age, number and type of medication used post laser and phakic status.

  Eligibility

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

Inclusion Criteria:

  • Only patients with clinical evidence of unilateral or bilateral open angle pseudoexfoliation ocular hypertension (IOP > 22mmHg) or glaucoma (Evidence on Humphrey 30-2 or Goldmann of nerve fiber layer damage) with uncontrolled IOP, over 18 years of age, and are willing to participate in the study will be included. If increased IOP is bilateral then the worst eye will be treated.

Exclusion Criteria:

  • Patients will be excluded if they have evidence of any glaucoma other than pseudoexfoliative open angle, if the trabecular meshwork cannot be seen in 360 degrees, if they had previous laser therapy ALT or SLT, if they have advanced visual field defect (split fixation or a scotoma within 10 degrees fixation), taking any systemic or topical steroids, have had any previous ocular surgery (glaucoma or cataract extraction included) or laser within the previous six months, if they are monocular patients, if they have any corneal disease precluding the angle evaluation and treatment, or if they had ocular trauma.
  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: NCT01126203

Locations
Canada, Alberta
Rockyview General Hospital Eye Clinic
Calgary, Alberta, Canada, T2V1P9
Canada, Ontario
St. Joseph's Health Care London Eye Clinic
London, Ontario, Canada, N6A 4V2
University of Ottawa Eye Institute
Ottawa, Ontario, Canada, K1H 8L6
Dr. C Birt
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Glaucoma Institute
Montreal, Quebec, Canada, H1V 1G5
Sponsors and Collaborators
University of Calgary
Canadian Glaucoma Clinical Research Council
Investigators
Principal Investigator: Andrew C Crichton University of Calgary
  More Information

No publications provided

Responsible Party: Andrew CS Crichton MD, FRCS(C), University of Calgary
ClinicalTrials.gov Identifier: NCT01126203     History of Changes
Other Study ID Numbers: SLT1
Study First Received: May 17, 2010
Last Updated: May 21, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Pseudoexfoliation
Glaucoma
Ocular Hypertension
SLT
Selective Laser Trabeculoplasy (SLT)
Argon Laser Trabeculoplasty (ALT)

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Exfoliation Syndrome
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 18, 2014