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Laser Treatment for Glaucoma Prevention in Corneal Disease

N/A

Recruiting

Led By Marie-Claude Robert, MD, MSc

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether a laser treatment can help prevent glaucoma in patients receiving a Boston keratoprosthesis, a device used to restore vision in patients who have failed traditional corneal transplants.

Who is the study for?

This trial is for adults who need a Boston keratoprosthesis (KPro) to replace their cornea and can follow the study's procedures. It excludes those under 18 or over 80, with severe ocular surface disease, terminal glaucoma, intra-ocular tumors, recent glaucoma surgery, or certain other conditions.

What is being tested?

The study tests if using transscleral cyclophotocoagulation (TS-CPC) before KPro surgery helps control eye pressure and prevent glaucoma. Participants are randomly assigned to receive either G-Probe TS-CPC or Micropulse TS-CPC from a specialist.

What are the potential side effects?

Potential side effects of TS-CPC may include discomfort in the eye, inflammation inside the eye, changes in vision or visual field loss due to laser application but specifics will vary based on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cup-to-disc ratio

Secondary study objectives

Goldman visual field loss of 30% or more.

Need of additional glaucoma intervention

No light perception

+1 more

Other study objectives

Complications related to the Boston keratoprosthesis

Complications related to transscleral cyclophotocoagulation treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: MicroPulse TreatmentExperimental Treatment1 Intervention

Prophylactic transscleral cyclophotocoagulation treatment, delivered by micropulse waves will be given 4-8 weeks before the Boston keratoprosthesis surgery.

Group II: G-Probe TreatmentExperimental Treatment1 Intervention

Prophylactic transscleral cyclophotocoagulation treatment, delivered with a diode laser using the G-Probe device, will be given 4-8 weeks before the Boston keratoprosthesis surgery.

Group III: Historical CohortActive Control1 Intervention

An historical cohort composed of patients who received a Boston keratoprosthesis between january 2017 and january 2019 will be included. Only patients who did not receive any glaucoma treatment 3 months before their surgery will be included. A total of 10 patients will be selected with the goal of matching the preoperative characteristics of the interventional patients. This group will serve as the control group in our study. Retrospective chart review will be performed for this branch.

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