Recruiting

KPro & GDD

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT02084745

Conditions

Corneal Transplantation

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Boston keratoprosthesis type 1

Glaucoma drainage device

Study Details

Brief summary:

Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea (transparent structure at the front of the eye) in patients who have failed or those who are expected to have poor results with traditional corneal transplantation. While the Kpro can offer dramatic improvement in vision, it is also associated with several complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of the most common complications after KPro surgery and can potentially cause irreversible vision loss. The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid inside the eye by bypassing the natural drainage system, is an effective option to lower the eye pressure in patients with KPro. Given the frequency and potentially devastating effects of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative measure. However, there is no consensus on when is the best timing to perform such surgery in relation to the Boston Kpro surgery.

Hypothesis:

For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the time of surgery, is more efficacious than at 6 months later, in the prevention of the progression of glaucoma and in maintaining better visual functions.

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.

Conditions

Corneal Transplantation

Glaucoma

Study ID

NCT02084745

Start date

May 26, 2014

Status verified date

Apr, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Boston keratoprosthesis type 1

The Boston KPro, purchased from Massachusetts Eye and Ear infirmary (Boston, MA), is implanted using the usual standard technique.

Glaucoma drainage device

The GDD that will be used is the Ahmed implant (New World Medical, Rancho Cucamonga, CA). The Ahmed implant will be implanted using the standard technique either at the time of KPro surgery in group 1, or 6 months following KPro in group 2.

Primary outcome measure

  • Visual field mean deviation [ Time Frame: Change from baseline visual field mean deviation at 12 months ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Principal Investigator:

Mona Harissi-Dagher, MD, FRCSC

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • Boston keratoprosthesis
  • Glaucoma drainage device

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 2024-04-12.