The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults patients

• Able to give an informed consent

• Capable of being followed during the study

• Candidate for the Boston keratoprosthesis type I

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Marie-Catherine Thessier, MSc
marie-catherine.tessier.chum@ssss.gouv.qc.ca
514 890-8000
Backup
Soumaya Bouhout, MD
soumaya.bouhout@umontreal.ca
5142640436
Time Frame
Start Date: 2020-01-30
Estimated Completion Date: 2036-12-01
Participants
Target number of participants: 20
Treatments
Experimental: MicroPulse Treatment
Prophylactic transscleral cyclophotocoagulation treatment, delivered by micropulse waves will be given 4-8 weeks before the Boston keratoprosthesis surgery.
Experimental: G-Probe Treatment
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.
No_intervention: Historical Cohort
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.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Fonds de recherche en ophtalmologie de l'Université de Montréal

This content was sourced from clinicaltrials.gov