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Cyclophotocoagulation in Glaucoma

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cyclophotocoagulation protocol
Conventional cyclophotocoagulation
Modified cyclophotocoagulation
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with poorly controlled high pressure glaucoma
  • Cyclophotocoagulation necessary to prevent visual loss
  • Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort

Exclusion Criteria:

  • Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
  • Patients receiving concomitant treatment the same day as the intervention
  • Patient not able to follow the prescribed post-operative treatment

Sites / Locations

  • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diode laser using conventional settings

Diode laser using modified settings

Arm Description

The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.

The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP) evolution
The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.

Secondary Outcome Measures

Presence of complications
Assessment of complications (if applicable).
Use of medication
Assessment of the topical and oral glaucoma medication at baseline and after treatment
Retreatment
The clinician will assess the need for retreatment based on clinical experience.
Visual acuity
The visual acuity will be assessed at baseline and each subsequent visit

Full Information

First Posted
July 18, 2016
Last Updated
September 8, 2023
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT02875158
Brief Title
Cyclophotocoagulation in Glaucoma
Official Title
Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2023 (Actual)
Study Completion Date
August 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure. The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diode laser using conventional settings
Arm Type
Active Comparator
Arm Description
The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.
Arm Title
Diode laser using modified settings
Arm Type
Experimental
Arm Description
The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.
Intervention Type
Procedure
Intervention Name(s)
Cyclophotocoagulation protocol
Intervention Description
Intravenous route is installed Retrobulbar anaesthesia : 50% xylocaine (2%) + 50% bupivicaine Parameters set for laser treatment (1250mW-4seconds or 2000mW-2 seconds depending on the assigned group) Pars plana measurement using transillumination (if needed) Laser treatment applied approximately 1mm post to limbus Dexamethasone 0,5 mg subconjunctival injection Post-op regimen: Prednisolone 1% qid x 4 weeks, Atropine 1% bid x 2 weeks + Erythromycin ointment + patch x 6h
Intervention Type
Procedure
Intervention Name(s)
Conventional cyclophotocoagulation
Intervention Description
1250 mW for 4 seconds.
Intervention Type
Procedure
Intervention Name(s)
Modified cyclophotocoagulation
Intervention Description
2000 mW for 2 seconds.
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP) evolution
Description
The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.
Time Frame
1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
Secondary Outcome Measure Information:
Title
Presence of complications
Description
Assessment of complications (if applicable).
Time Frame
During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
Title
Use of medication
Description
Assessment of the topical and oral glaucoma medication at baseline and after treatment
Time Frame
1 month, 6 months, 12 months, 18 months and 24 months post-op
Title
Retreatment
Description
The clinician will assess the need for retreatment based on clinical experience.
Time Frame
From the initial treatment up to the last visit (24 months)
Title
Visual acuity
Description
The visual acuity will be assessed at baseline and each subsequent visit
Time Frame
1 month, 6 months, 12 months, 18 months and 24 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with poorly controlled high pressure glaucoma Cyclophotocoagulation necessary to prevent visual loss Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort Exclusion Criteria: Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma Patients receiving concomitant treatment the same day as the intervention Patient not able to follow the prescribed post-operative treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Toren, Doctor
Organizational Affiliation
Centre de recherche du CHU de Québec : Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Cyclophotocoagulation in Glaucoma

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