The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis
Recruiting · NCT04232982 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Adults patients
- Able to give an informed consent
- Capable of being followed during the study
- Candidate for the Boston keratoprosthesis type I
Exclusion criteria
- Patients younger than 18 years old or older than 80 years old
- Unable to give an informed consent
- Participating to another interventional glaucoma study
- Patients who received a glaucoma surgery or procedure (glaucoma drainage device or TS-CPC treatment) 3 months before their initial visit.
- Unable to wear a therapeutic contact lens secondary to eyelid malformation
- Severe Ocular surface Disease with keratinization
- Intra-ocular tumor
- Terminal Glaucoma
- Phthisis bulbi
- Ocular albinism
Where it is running
1 location listed.
- Centre Hospitalier de l'Université de Montréal (CHUM) - Montreal, Quebec, Canada