NCT04232982

The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis

Recruiting now NA Last updated 19 April 2024

What this trial tests

NA trial testing Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA). in Glaucoma in 20 participants. Currently enrolling.

Timeline

30 January 2020

Primary endpoint
1 December 2034

1 December 2036

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	20
Start date	30 January 2020
Primary completion	1 December 2034
Estimated completion	1 December 2036
Sites	1 location across Canada

Drugs / interventions tested

• Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA).
• G-Probe transscleral cyclphophotocoagulation (Iris Medical Instruments, Montain View, CA)

Conditions studied

• Glaucoma — all drugs for Glaucoma →
• Eye Diseases — all drugs for Eye Diseases →
• Cornea Disease — all drugs for Cornea Disease →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

Adults 18 to 80, any sex, with Glaucoma or Eye Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Human retinal secretome: A cross-link between mesenchymal and retinal cells.
   Donato L, Scimone C, Alibrandi S, Scalinci SZ, et al · · 2023 · cited 6× · PMID 37545752 · DOI 10.4252/wjsc.v15.i7.665