20 Participants Needed

Laser Treatment for Glaucoma Prevention in Corneal Disease

MT
SB
Overseen BySoumaya Bouhout, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for glaucoma prevention in corneal disease?

Research shows that Micropulse Transscleral Cyclophotocoagulation (MP-CPC) is effective in treating glaucoma, with studies indicating it has a favorable safety profile and can reduce intraocular pressure, which is crucial in managing glaucoma.12345

Is laser treatment for glaucoma prevention in corneal disease safe?

Research shows that Micropulse Transscleral Cyclophotocoagulation (a type of laser treatment) is generally safe for treating glaucoma, with studies indicating a favorable safety profile compared to other methods. However, it can cause some inflammation in the eye, which is a common side effect.34678

How does the laser treatment for glaucoma prevention in corneal disease differ from other treatments?

This laser treatment uses micropulse technology, which delivers laser energy in short bursts, reducing the risk of damage compared to continuous-wave laser treatments. It is considered safer and has a favorable safety profile, making it a novel option for managing glaucoma.348910

What is the purpose of this trial?

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.

Research Team

MR

Marie-Claude Robert, MD, MSc

Principal Investigator

Ophthalmology Department, Centre Hospitalier de l'Université de Montreal

Eligibility Criteria

This trial is for adults who need a Boston keratoprosthesis (KPro) to replace their cornea and can follow the study's procedures. It excludes those under 18 or over 80, with severe ocular surface disease, terminal glaucoma, intra-ocular tumors, recent glaucoma surgery, or certain other conditions.

Inclusion Criteria

Able to give an informed consent
I am 18 years old or older.
Candidate for the Boston keratoprosthesis type I

Exclusion Criteria

I have ocular albinism.
I have a tumor inside my eye.
I am unable to understand and agree to the study's details on my own.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prophylactic Treatment

Participants receive prophylactic transscleral cyclophotocoagulation treatment 4-8 weeks before Boston keratoprosthesis surgery

4-8 weeks
1 visit (in-person)

Post-Treatment Follow-up

Participants are examined by a glaucoma specialist 1 week following the laser treatment

1 week
1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety and effectiveness after Boston keratoprosthesis surgery

5 years
Day-1, weeks 1 and 2, months 1 and 3, then every 4-6 months

Treatment Details

Interventions

  • G-Probe transscleral cyclphophotocoagulation
  • Transscleral cyclphophotocoagulation using the Micropulse system
Trial Overview The study tests if using transscleral cyclophotocoagulation (TS-CPC) before KPro surgery helps control eye pressure and prevent glaucoma. Participants are randomly assigned to receive either G-Probe TS-CPC or Micropulse TS-CPC from a specialist.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: MicroPulse TreatmentExperimental Treatment1 Intervention
Prophylactic transscleral cyclophotocoagulation treatment, delivered by micropulse waves will be given 4-8 weeks before the Boston keratoprosthesis surgery.
Group II: G-Probe TreatmentExperimental Treatment1 Intervention
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.
Group III: Historical CohortActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Fonds de recherche en ophtalmologie de l'Université de Montréal

Collaborator

Trials
6
Recruited
160+

Findings from Research

Micropulse transscleral cyclophotocoagulation (MP-TSCPC) effectively reduced intraocular pressure (IOP) in patients with uncontrolled glaucoma, achieving a mean reduction of 41.2% at one month and continuing to lower IOP over a 12-month follow-up period.
While MP-TSCPC decreased the need for ocular antihypertensive medications, it was associated with complications such as inflammation and vision loss in some patients, indicating the need for careful patient selection and monitoring.
Micropulse Cyclophotocoagulation: Initial Results in Refractory Glaucoma.Emanuel, ME., Grover, DS., Fellman, RL., et al.[2022]
Micropulse cyclophotocoagulation (MP CPC) demonstrated a 30% or greater reduction in intraocular pressure (IOP) in 53.4% of treated eyes among a cohort of 47 patients with various types of glaucoma, indicating its efficacy as a treatment option.
The procedure is non-incisional with a high safety profile and minimal complications, making it suitable for patients with different stages and types of glaucoma, and it can be repeated if necessary.
Our experience with micropulse cyclophotocoagulation in the therapy of glaucoma.Nutterová, E., Pitrová, Š., Lešták, J.[2020]
MicroPulse transscleral laser therapy (MP-TLT) is as effective as continuous-wave transscleral cyclophotocoagulation (CW-TSCPC) in lowering intraocular pressure (IOP) in glaucoma patients, with success rates of 87.5% for MP-TLT and 88.6% for CW-TSCPC after 12 months.
MP-TLT has a better safety profile, allowing it to be used in earlier stages of glaucoma and in patients with good central vision, making it a promising option for broader treatment applications.
MicroPulse Transscleral Laser Therapy Demonstrates Similar Efficacy with a Superior and More Favorable Safety Profile Compared to Continuous-Wave Transscleral Cyclophotocoagulation.Bernardi, E., Töteberg-Harms, M.[2022]

References

Micropulse Cyclophotocoagulation: Initial Results in Refractory Glaucoma. [2022]
2.Czech Republicpubmed.ncbi.nlm.nih.gov
Our experience with micropulse cyclophotocoagulation in the therapy of glaucoma. [2020]
MicroPulse Transscleral Laser Therapy Demonstrates Similar Efficacy with a Superior and More Favorable Safety Profile Compared to Continuous-Wave Transscleral Cyclophotocoagulation. [2022]
Correlation between intraocular pressure reduction and anterior chamber aqueous flare after micropulse transscleral cyclophotocoagulation. [2021]
Clinical Efficacy and Safety Profile of Micropulse Transscleral Cyclophotocoagulation in Refractory Glaucoma. [2022]
Outcome Of MicroPulse® Transscleral Photocoagulation In Different Types Of Glaucoma. [2022]
Short-term outcomes of micropulse transscleral cyclophotocoagulation as a primary versus additional therapy in eyes with uncontrolled glaucoma. [2023]
Micropulse Trans-scleral Cyclophotocoagulation in Patients With Glaucoma: 1- and 2-Year Treatment Outcomes. [2021]
Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Update on Micropulse Transscleral Cyclophotocoagulation. [2021]
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