Laser Treatment for Glaucoma Prevention in Corneal Disease
Trial Summary
What is the purpose of this trial?
The Boston keratoprosthesis (KPro) is a special plastic device that is used to replace a sick cornea (transparent part of the eye, in front of the iris) in order to restore vision in patients who have failed traditional corneal transplants or have a very poor prognosis of success. Glaucoma is a chronic disease which causes optic nerve damage secondary to high pressure inside the eye and could lead to vision loss in the long term. Glaucoma is highly prevalent in patients who require a KPro and even more after their procedure. In order to decrease the intra-ocular pressure, surgeons can use multiple eyedrops. Unfortunately, following the KPro surgery, eyedrops lose their efficiency because they are less absorbed by the eye. The transscleral cyclophotocoagulation (TS-CPC) is a laser treatment used in advanced refractory glaucoma. This laser helps decrease the intra-ocular pressure and have a better control of the disease. There are different methods of laser transmission, including the continuous transmission (G-Probe) and the micro-pulsation method (Micopulse). Given the high prevalence of glaucoma in patients receiving a KPro, the investigators are studying the effect of giving the TS-CPC treatment prophylactically to patients before their Boston keratoprosthesis. Our hypothesis is that prophylactic TS-CPC will decrease glaucoma progression as well as the risks of developing glaucoma following the Boston keratoprosthesis . METHOD The investigators aim to recruit twenty (20) patients who are scheduled to receive Boston KPro. Participants will be randomized into two groups: 1) Groupe 1 will receive a prophylactic treatment of transscleral cyclophotocoagulation a G-Probe. 2) Groupe 2 will receive a prophylactic treatment of transscleral cyclophotocoagulation with a micropulse transmission (MicroPulse). The patients will receive their laser treatment by a glaucoma specialist 4 to 8 weeks before their KPro surgery. One week following their laser treatment, the participants will be examined by their glaucoma specialist. Following their KPro surgery, patients will have a follow-up at day-1, weeks 1 and 2, months 1 and 3, then every 4 to 6 months for 5 years. Additional non-invasive glaucoma tests will be performed twice during the first 3 months following the surgery and will be repeated every 4-6 months. Visual acuity results, the visual field tests and rates of post-operative complications will be compared between the different groups.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for glaucoma prevention in corneal disease?
Is laser treatment for glaucoma prevention in corneal disease safe?
Research shows that Micropulse Transscleral Cyclophotocoagulation (a type of laser treatment) is generally safe for treating glaucoma, with studies indicating a favorable safety profile compared to other methods. However, it can cause some inflammation in the eye, which is a common side effect.34678
How does the laser treatment for glaucoma prevention in corneal disease differ from other treatments?
Research Team
Marie-Claude Robert, MD, MSc
Principal Investigator
Ophthalmology Department, Centre Hospitalier de l'Université de Montreal
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Prophylactic Treatment
Participants receive prophylactic transscleral cyclophotocoagulation treatment 4-8 weeks before Boston keratoprosthesis surgery
Post-Treatment Follow-up
Participants are examined by a glaucoma specialist 1 week following the laser treatment
Postoperative Follow-up
Participants are monitored for safety and effectiveness after Boston keratoprosthesis surgery
Treatment Details
Interventions
- G-Probe transscleral cyclphophotocoagulation (Procedure)
- Transscleral cyclphophotocoagulation using the Micropulse system (Procedure)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Fonds de recherche en ophtalmologie de l'Université de Montréal
Collaborator