Cyclophotocoagulation in Glaucoma

Glaucoma Clinical Trial

Official title:

Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875158
• Other study ID #: 2015-2212
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2023

Study information

• Verified date: September 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Cyclophotocoagulation protocol
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
• Conventional cyclophotocoagulation
1250 mW for 4 seconds.
• Modified cyclophotocoagulation
2000 mW for 2 seconds.

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) evolution	The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.	1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
Secondary	Presence of complications	Assessment of complications (if applicable).	During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
Secondary	Use of medication	Assessment of the topical and oral glaucoma medication at baseline and after treatment	1 month, 6 months, 12 months, 18 months and 24 months post-op
Secondary	Retreatment	The clinician will assess the need for retreatment based on clinical experience.	From the initial treatment up to the last visit (24 months)
Secondary	Visual acuity	The visual acuity will be assessed at baseline and each subsequent visit	1 month, 6 months, 12 months, 18 months and 24 months post-op