RecruitingNot ApplicableNCT04232982

The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

20 participants

Start Date

Jan 30, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a procedure called transscleral cyclophotocoagulation (a laser treatment applied to the outside of the eye) can help control eye pressure in patients who have a Boston Keratoprosthesis — a special artificial cornea — and also have glaucoma (a condition where high eye pressure damages vision). **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled to receive a Boston Keratoprosthesis type I (a type of artificial cornea implant) - You have glaucoma that needs to be managed alongside your eye surgery - You are able to give informed consent and attend follow-up **You may NOT be eligible if...** - You are younger than 18 or older than 80 - You have had a glaucoma surgery or laser procedure within the last 3 months - You are unable to wear a therapeutic contact lens - You have severe eye surface disease, an intraocular tumor, end-stage glaucoma, or a shrunken (phthisical) eye - You are participating in another glaucoma study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETransscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA).

Treatment will be applied over the limbal area to treat the ciliary body. The treatment will be delivered with an energy of 2000mW, a cycle of 31,33% and an on/off time of 0,5ms and 1,1ms. It will be delivered around a 360° surface with avoidance of the 3 and 9 o'clock areas. The treatment will be delivered during 80 secondes in each hemisphere and will be repeated twice, for a total of 320 secondes.

PROCEDUREG-Probe transscleral cyclphophotocoagulation (Iris Medical Instruments, Montain View, CA)

Treatment will be applied over the limbal area to treat the ciliary body. Sixteen (16) shots in total, which is four (4) shorts per quadrants, will be transmitted with a power from 1750 to 2000mV (titrating according to an audible "pop") for a length of 2,0 secondes per shots. Treatment will be delivered around a 360° surface and avoiding the 3 and 9 o'clock areas.


Locations(1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

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NCT04232982


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