Cyclophotocoagulation in Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT02875158
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-18
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) evolution	1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op	The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.

Secondary Outcome Measures

Name	Time	Method
Presence of complications	During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op	Assessment of complications (if applicable).
Use of medication	1 month, 6 months, 12 months, 18 months and 24 months post-op	Assessment of the topical and oral glaucoma medication at baseline and after treatment
Retreatment	From the initial treatment up to the last visit (24 months)	The clinician will assess the need for retreatment based on clinical experience.
Visual acuity	1 month, 6 months, 12 months, 18 months and 24 months post-op	The visual acuity will be assessed at baseline and each subsequent visit

Trial Locations

Locations (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec; 🇨🇦 Québec, Canada