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

NCT ID: NCT04337944

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2025-03-31

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.

Detailed 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.

Conditions

Corneal Transplantation; Glaucoma and Ocular Hypertension; Postoperative Complications; Vitrectomy; Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Harissi-Dagher, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marie-Catherine Tessier, M.Sc.

Role: CONTACT

marie-catherine.tessier.chum@ssss.gouv.qc.ca

1-514-890-8000 ext. 11550

Dominique Geoffrion, B.Sc.

Role: CONTACT

dominique.geoffrion@mail.mcgill.ca

1-514-890-8000 ext. 11550

Facility Contacts

Marie-Catherine Tessier, M.Sc.

Role: primary

marie-catherine.tessier.chum@ssss.gouv.qc.ca

1-514-890-8000 ext. 11550

References

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Reference Type: BACKGROUND

PMID: 32066560 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25174898 (View on PubMed)

Harissi-Dagher M, Durr GM, Biernacki K, Sebag M, Rheaume MA. Pars plana vitrectomy through the Boston Keratoprosthesis type 1. Eye (Lond). 2013 Jun;27(6):767-9. doi: 10.1038/eye.2013.58. Epub 2013 Apr 12.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31453878 (View on PubMed)

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Reference Type: BACKGROUND

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Khan BF, Harissi-Dagher M, Khan DM, Dohlman CH. Advances in Boston keratoprosthesis: enhancing retention and prevention of infection and inflammation. Int Ophthalmol Clin. 2007 Spring;47(2):61-71. doi: 10.1097/IIO.0b013e318036bd8b. No abstract available.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Yu YZ, Zou YP, Zou XL. Endoscopy-assisted vitrectomy in the anterior vitreous. Int J Ophthalmol. 2018 Mar 18;11(3):506-511. doi: 10.18240/ijo.2018.03.23. eCollection 2018.

Reference Type: BACKGROUND

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Other Identifiers

CE19.382

Identifier Type: -

Identifier Source: org_study_id