Recruiting

Transscleral Cyclophotocoagulation

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04232982

Conditions

Glaucoma

Eye Diseases

Cornea Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief 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.

Conditions

Glaucoma

Eye Diseases

Cornea Disease

Study ID

NCT04232982

Start date

Jan 30, 2020

Status verified date

Apr, 2026

Completion date

Dec 1, 2036

Anticipated

Primary completion date

Dec 1, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Transscleral 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.

G-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.

Primary outcome measure

  • Cup-to-disc ratio [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • Boston keratoprosthesis
  • Transscleral cyclophotocoagulation
  • Micropulse transscleral cyclophotocoagulation
  • G-Probe Transscleral cyclophotocoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-27.