Timing of Glaucoma Drainage Device Implantation With Boston Keratoprosthesis Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: The investigators aim to recruit 40 patients over 4 years. Recruited patients will be randomly assigned to 2 groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD implantation 6 months after the Boston KPro surgery. Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week 1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit. Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo) will be performed on day 1, month 1, 3, 6 and 12. For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery. They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1. Results of visual acuity, visual fields, optic nerve evaluation and complications will be compared between the two groups to determine the better timing of GDD implantation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Mona Harissi-Dagher, MD, FRCSC
monadagher@hotmail.com
1-514-890-8000
Backup
Dominique Geoffrion, BSc
dominique.geoffrion@mail.mcgill.ca
1-514-890-8000
Time Frame
Start Date: 2014-05-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Simultaneous implantation
Simultaneous implantation of a glaucoma drainage device at the time of Boston keratoprosthesis type 1 surgery
Active_comparator: Implantation at post-Kpro at 6 months
Implantation of a glaucoma drainage device 6 months after Boston keratoprosthesis type 1 surgery
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov