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GDD Timing with Boston KPro for Glaucoma (GDD-KPro Trial)

N/A
Recruiting
Led By Mona Harissi-Dagher, MD, FRCSC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Physical condition suitable for undergoing surgery
Must not have
Terminal glaucoma
Terminal retinal diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline ddls on optic nerve photographs at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help surgeons to determine whether it is better to implant a glaucoma drainage device (GDD) at the time of the Boston KPro surgery or 6 months later, in the prevention of the progression of glaucoma.

Who is the study for?
This trial is for adults over 18 who've had a failed corneal transplant and have poor vision (20/80 or worse) in the affected eye. They should be physically fit for surgery but not have end-stage glaucoma or terminal retinal diseases.
What is being tested?
The study tests if getting a Glaucoma Drainage Device (GDD) at the same time as Boston Keratoprosthesis (KPro) surgery is better than waiting 6 months. The goal is to see which timing best prevents glaucoma progression and maintains vision.
What are the potential side effects?
Potential side effects may include complications related to KPro such as further vision loss, infection, or issues with the GDD like discomfort or improper drainage of eye fluid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fit for surgery.
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I need a corneal transplant because my cornea is not clear.
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I have had a corneal transplant that did not succeed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with terminal glaucoma.
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I have a severe eye condition that affects my vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline visual field mean deviation at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline visual field mean deviation at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual field mean deviation
Secondary study objectives
Change of visual acuity
Disc Damage Likelihood Scale (DDLS) on clinical examination
Disc Damage Likelihood Scale (DDLS) on stereoscopic photographs of the optic nerve
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Simultaneous implantationActive Control2 Interventions
Simultaneous implantation of a glaucoma drainage device at the time of Boston keratoprosthesis type 1 surgery
Group II: Implantation at post-Kpro at 6 monthsActive Control2 Interventions
Implantation of a glaucoma drainage device 6 months after Boston keratoprosthesis type 1 surgery

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,480 Total Patients Enrolled
7 Trials studying Glaucoma
390 Patients Enrolled for Glaucoma
Mona Harissi-Dagher, MD, FRCSCPrincipal InvestigatorDepartment of Ophthalmology, Centre Hospitalier de l'Université de Montréal

Media Library

Boston keratoprosthesis type 1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02084745 — N/A
Glaucoma Research Study Groups: Simultaneous implantation, Implantation at post-Kpro at 6 months
Glaucoma Clinical Trial 2023: Boston keratoprosthesis type 1 Highlights & Side Effects. Trial Name: NCT02084745 — N/A
Boston keratoprosthesis type 1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02084745 — N/A
~4 spots leftby Dec 2025
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