Cyclophotocoagulation in Glaucoma

NCT ID: NCT02875158

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diode laser using conventional settings

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

Group Type ACTIVE_COMPARATOR

Cyclophotocoagulation protocol

Intervention Type PROCEDURE

* 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

Intervention Type PROCEDURE

1250 mW for 4 seconds.

Diode laser using modified settings

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

Group Type EXPERIMENTAL

Cyclophotocoagulation protocol

Intervention Type PROCEDURE

* 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

Modified cyclophotocoagulation

Intervention Type PROCEDURE

2000 mW for 2 seconds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Conventional cyclophotocoagulation

1250 mW for 4 seconds.

Intervention Type PROCEDURE

Modified cyclophotocoagulation

2000 mW for 2 seconds.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew Toren, Doctor

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du CHU de Québec : Université Laval

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Québec, , Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-2212

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.