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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

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 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

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.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
372 Previous Clinical Trials
131,011 Total Patients Enrolled
Fonds de recherche en ophtalmologie de l'Université de MontréalOTHER
5 Previous Clinical Trials
139 Total Patients Enrolled
Marie-Claude Robert, MD, MScPrincipal InvestigatorOphthalmology Department, Centre Hospitalier de l'Université de Montreal

Media Library

Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA). Clinical Trial Eligibility Overview. Trial Name: NCT04232982 — N/A
Corneal Disease Research Study Groups: Historical Cohort, G-Probe Treatment, MicroPulse Treatment
Corneal Disease Clinical Trial 2023: Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA). Highlights & Side Effects. Trial Name: NCT04232982 — N/A
Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA). 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232982 — N/A
~13 spots leftby Dec 2034
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