Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis (KPro-HP-Endo) (KPro-HP-Endo)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2025
  • participants needed
    20
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 4 October 2022
Accepts healthy volunteers

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.

Description

Boston keratoprosthesis type 1 (KPro) surgery is the most common corneal graft and is used to restore vision in patients with high risk of failure with traditional penetrating keratoplasty. Common complications of KPro surgery include retroprosthetic membrane formation behind the backplate of the KPro. Glaucoma is the most common threat to vision rehabilitation in patients with KPro. Glaucoma is often present before surgery and progresses after KPro, seven times faster than in patients with only glaucoma. Retinal detachment is a common posterior segment complication that arises post-KPro and can lead to a serious loss of vision. Pars plana vitrectomy (PPV) is the standard treatment for patients with vitreoretinal diseases and opacities. PPV can include peeling of the anterior hyaloid membrane to ensure total resection of the vitreous body. PPV allows for example for retroprosthetic membrane excision, installation or revision of a glaucoma drainage device, or repair of retinal detachment. Often 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. Combined surgeries of KPro and PPV offer a complete evaluation of the optic nerve and of the retina, which would not be possible otherwise. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, especially with a KPro in place. Visualisation can be improved using endoscopy to visualize the inside of the eye over 360 degrees. 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.

Details
Condition Corneal Transplantation, Glaucoma and Ocular Hypertension, Postoperative Complications, Vitrectomy, Endoscopy
Treatment Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy
Clinical Study IdentifierNCT04337944
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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