Recruiting

KPro-HP-Endo

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04337944

Conditions

Corneal Transplantation

Glaucoma and Ocular Hypertension

Postoperative Complications

Vitrectomy

Endoscopy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy

Study Details

Brief summary:

Common complications of the Boston keratoprosthesis type 1 (KPro) surgery include retroprosthetic membrane formation, glaucoma, and retinal detachment. Often pars plana vitrectomy (PPV) is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, but it can be improved using endoscopy. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.

Conditions

Corneal Transplantation

Glaucoma and Ocular Hypertension

Postoperative Complications

Vitrectomy

Endoscopy

Study ID

NCT04337944

Start date

Apr 8, 2020

Status verified date

Jul, 2023

Completion date

Mar, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Aged from 18 to 80 years old
  • Informed consent
  • Boston keratoprosthesis candidate
  • Pars plana vitrectomy candidate
  • Ability to be followed for the duration of the study

Exclusion Criteria:

  • Aged less than 18 or more than 80 years old
  • Inability to give informed consent
  • Repeat Boston keratoprosthesis
  • Repeat pars plana vitrectomy

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patients with KPro, PPV, and endoscopy

Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy.

Interventions

Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy

Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy.

Primary outcome measure

  • Rate of retroprosthetic membrane formation [ Time Frame: 12 months ]
  • Rate of retinal detachment [ Time Frame: 12 months ]
  • Rate of glaucoma development [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Principal Investigator:

Mona Harissi-Dagher, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Keywords

  • Boston keratoprosthesis type 1
  • Pars plana vitrectomy
  • Endoscopy

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 2023-07-27.