Timing of glaucoma drainage device placement with Boston keratoprosthesis
Timing of Glaucoma Drainage Device Implantation With Boston Keratoprosthesis Surgery
This study is trying to find out the best time to place a glaucoma drainage device for patients getting a Boston keratoprosthesis to help prevent vision loss from glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02084745 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal timing for the implantation of a glaucoma drainage device (GDD) in patients receiving a Boston keratoprosthesis (KPro) for corneal transplantation. The KPro is used to replace a damaged cornea in patients with a history of failed corneal transplants, but it can lead to complications such as glaucoma. The study aims to determine the best approach to prevent glaucoma-related vision loss by assessing the timing of GDD placement in relation to KPro surgery. By analyzing patient outcomes, the study seeks to establish guidelines for managing glaucoma in this complex patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require corneal transplantation due to previous transplant failures and have poor visual acuity.
Not a fit: Patients with terminal glaucoma or severe retinal diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of glaucoma and associated vision loss in patients undergoing corneal transplantation with KPro.
How similar studies have performed: While the management of glaucoma in KPro patients is challenging, there is limited consensus on the timing of GDD placement, indicating that this approach may be novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidate for corneal transplantation due to loss of corneal clarity * Verifiable history of one or more previous full thickness donor corneal transplantation failure * Pre-operative visual acuity of ≤20/80 or worse in the surgical eye * Age ≥18 years * Physical condition suitable for undergoing surgery Exclusion Criteria: * Terminal glaucoma * Terminal retinal diseases
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Mona Harissi-Dagher, MD, FRCSC — Department of Ophthalmology, Centre Hospitalier de l'Université de Montréal
- Study coordinator: Mona Harissi-Dagher, MD, FRCSC
- Email: monadagher@hotmail.com
- Phone: 1-514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.