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

Primary Purpose

Exfoliation Syndrome, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

SLT

ALT

About this trial

This is an interventional treatment trial for Exfoliation Syndrome focused on measuring Pseudoexfoliation, Glaucoma, Ocular Hypertension, SLT, Selective Laser Trabeculoplasy (SLT), Argon Laser Trabeculoplasty (ALT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rockyview General Hospital Eye Clinic
St. Joseph's Health Care London Eye Clinic
University of Ottawa Eye Institute
Dr. C Birt
Montreal Glaucoma Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

selective laser trabeculoplasty (SLT)

Argon laser trabeculoplasty (ALT)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01126203

First Posted

May 17, 2010

Last Updated

May 21, 2010

Sponsor

University of Calgary

Collaborators

Canadian Glaucoma Clinical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT01126203

Brief Title

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

Acronym

SLT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

Collaborators

Canadian Glaucoma Clinical Research Council

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exfoliation Syndrome, Ocular Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

selective laser trabeculoplasty (SLT)

Arm Type

Experimental

Arm Title

Argon laser trabeculoplasty (ALT)

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

SLT

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

ALT

Intervention Description

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.

Primary Outcome Measure Information:

Title

IOP (Intraocular Pressure)

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew C Crichton

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rockyview General Hospital Eye Clinic

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2V1P9

Country

Canada

Facility Name

St. Joseph's Health Care London Eye Clinic

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

University of Ottawa Eye Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Dr. C Birt

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Montreal Glaucoma Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1V 1G5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

35943114

Citation

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.

Results Reference

derived

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

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