Timing of Glaucoma Drainage Device With Boston Keratoprosthesis

NCT02084745 | Recruiting

• 1 other identifier: CE13.277
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Boston keratoprosthesis; Glaucoma drainage device

Outcome Measures

Primary Outcomes (1)

• Visual field mean deviation

  Humphrey Visual Field 24-2 (SITA-Fast) (or Goldmann if poor vision/reliability)

  Change from baseline visual field mean deviation at 12 months

Secondary Outcomes (4)

• Disc Damage Likelihood Scale (DDLS) on clinical examination

  Change from baseline DDLS on clinical examination at 12 months

• Disc Damage Likelihood Scale (DDLS) on stereoscopic photographs of the optic nerve

  Change from baseline DDLS on optic nerve photographs at 12 months

• Incidence of ocular complications

  12 months after KPro

• Change of visual acuity

  12 months after KPro

Study Arms (2)

Simultaneous implantation

ACTIVE COMPARATOR

Simultaneous implantation of a glaucoma drainage device at the time of Boston keratoprosthesis type 1 surgery

Procedure: Boston keratoprosthesis type 1; Procedure: Glaucoma drainage device

Implantation at post-Kpro at 6 months

ACTIVE COMPARATOR

Implantation of a glaucoma drainage device 6 months after Boston keratoprosthesis type 1 surgery

Procedure: Boston keratoprosthesis type 1; Procedure: Glaucoma drainage device

Interventions

Boston keratoprosthesis type 1 PROCEDURE

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

Also known as: Boston KPro type 1

Implantation at post-Kpro at 6 months; Simultaneous implantation

Glaucoma drainage device PROCEDURE

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.

Also known as: Ahmed Glaucoma Valve

Implantation at post-Kpro at 6 months; Simultaneous implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Terminal glaucoma
• Terminal retinal diseases

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 (4)

• Chew HF, Ayres BD, Hammersmith KM, Rapuano CJ, Laibson PR, Myers JS, Jin YP, Cohen EJ. Boston keratoprosthesis outcomes and complications. Cornea. 2009 Oct;28(9):989-96. doi: 10.1097/ICO.0b013e3181a186dc.

  PMID: 19724214 BACKGROUND

• Banitt M. Evaluation and management of glaucoma after keratoprosthesis. Curr Opin Ophthalmol. 2011 Mar;22(2):133-6. doi: 10.1097/ICU.0b013e328343723d.

  PMID: 21191292 BACKGROUND

• Aldave AJ, Kamal KM, Vo RC, Yu F. The Boston type I keratoprosthesis: improving outcomes and expanding indications. Ophthalmology. 2009 Apr;116(4):640-51. doi: 10.1016/j.ophtha.2008.12.058. Epub 2009 Feb 25.

  PMID: 19243830 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

MeSH Terms

Conditions

Glaucoma

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Mona Harissi-Dagher, MD, FRCSC

  Department of Ophthalmology, Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Harissi-Dagher, MD, FRCSC

CONTACT

1-514-890-8000; monadagher@hotmail.com

Dominique Geoffrion, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized with a 1:1 allocation into two groups. Group 1 will comprise 20 patients undergoing KPro and simultaneous GDD while group 2 will include 20 patients undergoing KPro and then GDD 6 months later. Randomization schedule will be computer generated.

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 12, 2014
• Study Start: May 26, 2014
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)