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

NCT04337944 | Unknown

• 1 other identifier: CE19.382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Boston keratoprosthesis type 1; Pars plana vitrectomy; Endoscopy

Outcome Measures

Primary Outcomes (3)

• Rate of retroprosthetic membrane formation

  Rate of postoperative retroprosthetic membrane formation behind the backplate of the Boston keratoprosthesis. Retroprosthetic membrane formation is diagnosed by the investigator using an examination of the anterior chamber performed at the slit-lamp.

  12 months

• Rate of retinal detachment

  Rate of postoperative retinal detachment. Retinal detachment is diagnosed by the investigator using a dilated fundus (retinal) examination performed at the slit-lamp.

  12 months

• Rate of glaucoma development

  Rate of development or progression of glaucoma, determined based on intraocular pressure increase of \> 21 mmHg, increase of glaucoma medications, optic nerve excavation progression, or need to undergo glaucoma filtration surgery.

  12 months

Secondary Outcomes (8)

• Proportion of patients with visual acuity better than 20/200

  12 months

• Change of visual acuity

  12 months

• Time to retroprosthetic membrane formation after surgery

  12 months

• Time to retinal detachment after surgery

  12 months

• Proportion of participants requiring glaucoma surgery

  12 months

Study Arms (1)

Patients with KPro, PPV, and endoscopy

EXPERIMENTAL

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.

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

Interventions

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

Patients with KPro, PPV, and endoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Related Publications (12)

• Szigiato AA, Bostan C, Nayman T, Harissi-Dagher M. Long-term visual outcomes of the Boston type I keratoprosthesis in Canada. Br J Ophthalmol. 2020 Nov;104(11):1601-1607. doi: 10.1136/bjophthalmol-2019-315345. Epub 2020 Feb 17.

  PMID: 32066560 BACKGROUND

• Wang Q, Harissi-Dagher M. Characteristics and management of patients with Boston type 1 keratoprosthesis explantation--the University of Montreal Hospital Center experience. Am J Ophthalmol. 2014 Dec;158(6):1297-1304.e1. doi: 10.1016/j.ajo.2014.08.037. Epub 2014 Aug 28.

  PMID: 25174898 BACKGROUND

• 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.

  PMID: 23579405 BACKGROUND

• Robert MC, Pomerleau V, Harissi-Dagher M. Complications associated with Boston keratoprosthesis type 1 and glaucoma drainage devices. Br J Ophthalmol. 2013 May;97(5):573-7. doi: 10.1136/bjophthalmol-2012-302770. Epub 2013 Feb 23.

  PMID: 23435225 BACKGROUND

• Moussally K, Harissi-Dagher M. Long-term complications associated with glaucoma drainage devices and Boston keratoprosthesis. Am J Ophthalmol. 2011 Nov;152(5):883-4; author reply 884-5. doi: 10.1016/j.ajo.2011.07.014. No abstract available.

  PMID: 22017851 BACKGROUND

• Talajic JC, Agoumi Y, Gagne S, Moussally K, Harissi-Dagher M. Prevalence, progression, and impact of glaucoma on vision after Boston type 1 keratoprosthesis surgery. Am J Ophthalmol. 2012 Feb;153(2):267-274.e1. doi: 10.1016/j.ajo.2011.07.022. Epub 2011 Oct 7.

  PMID: 21982110 BACKGROUND

• Dohlman CH, Zhou C, Lei F, Cade F, Regatieri CV, Crnej A, Dohlman JG, Shen LQ, Paschalis EI. Glaucoma After Corneal Trauma or Surgery-A Rapid, Inflammatory, IOP-Independent Pathway. Cornea. 2019 Dec;38(12):1589-1594. doi: 10.1097/ICO.0000000000002106.

  PMID: 31453878 BACKGROUND

• Crnej A, Paschalis EI, Salvador-Culla B, Tauber A, Drnovsek-Olup B, Shen LQ, Dohlman CH. Glaucoma progression and role of glaucoma surgery in patients with Boston keratoprosthesis. Cornea. 2014 Apr;33(4):349-54. doi: 10.1097/ICO.0000000000000067.

  PMID: 24531120 BACKGROUND

• 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.

  PMID: 17450007 BACKGROUND

• Boscher C, Kuhn F. Endoscopic evaluation and dissection of the anterior vitreous base. Ophthalmic Res. 2015;53(2):90-9. doi: 10.1159/000370032. Epub 2015 Jan 27.

  PMID: 25633467 BACKGROUND

• Modjtahedi BS, Eliott D. Vitreoretinal complications of the Boston Keratoprosthesis. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):338-48. doi: 10.3109/08820538.2014.959204.

  PMID: 25325859 BACKGROUND

• 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.

  PMID: 29600187 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Postoperative Complications

Condition Hierarchy (Ancestors)

Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mona Harissi-Dagher, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Catherine Tessier, M.Sc.

CONTACT

1-514-890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Dominique Geoffrion, B.Sc.

CONTACT

1-514-890-8000; dominique.geoffrion@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective study on patients receiving a Boston keratoprosthesis type 1, using a retrospective group as the control group.

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: April 8, 2020
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)