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

NCT01126203 | Completed Phase 3 DMC

• 1 other identifier: SLT1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Pseudoexfoliation; Glaucoma; Ocular Hypertension; SLT; Selective Laser Trabeculoplasy (SLT); Argon Laser Trabeculoplasty (ALT)

Outcome Measures

Primary Outcomes (1)

• IOP (Intraocular Pressure)

  The main primary outcome variable will be the intraocular pressures (IOP) at 1 hour, 6 weeks, 3, 6 \& 12 months post-operatively

  1 hour, 6 weeks, 3, 6 &12 months

Study Arms (2)

selective laser trabeculoplasty (SLT)

EXPERIMENTAL

Procedure: SLT

Argon laser trabeculoplasty (ALT)

EXPERIMENTAL

Procedure: ALT

Interventions

SLT PROCEDURE

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.

selective laser trabeculoplasty (SLT)

ALT PROCEDURE

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.

Argon laser trabeculoplasty (ALT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Glaucoma Clinical Research Council: collaborator

Study Sites (5)

Rockyview General Hospital Eye Clinic

Calgary, Alberta, T2V1P9, Canada

Location

St. Joseph's Health Care London Eye Clinic

London, Ontario, N6A 4V2, Canada

Location

University of Ottawa Eye Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Dr. C Birt

Toronto, Ontario, M4N 3M5, Canada

Location

Montreal Glaucoma Institute

Montreal, Quebec, H1V 1G5, Canada

Location

Related Publications (1)

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

  PMID: 35943114 DERIVED

MeSH Terms

Conditions

Exfoliation Syndrome; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Study Officials

• Andrew C Crichton

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 24, 2010

Record last verified: 2010-05

Locations

CA (5)