Timing of Glaucoma Drainage Device With Boston KPro Surgery (GDD-KPro)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT02084745
First received: February 27, 2014
Last updated: March 10, 2014
Last verified: February 2014
  Purpose

Introduction:

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:

We aim to recruit 60 patients over 2 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.


Condition Intervention
Corneal Diseases
Corneal Opacity
Device: Boston keratoprosthesis type 2
Device: Glaucoma drainage device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Timing of Glaucoma Drainage Device Implantation With Boston Keratoprosthesis Surgery

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Visual field mean deviation [ Time Frame: Change from baseline visual field mean deviation at 12 months ] [ Designated as safety issue: No ]
    Humphrey Visual Field 24-2 (SITA-Fast) (or Goldmann if poor vision/reliability)


Secondary Outcome Measures:
  • Disc Damage Likelihood Scale (DDLS) on clinical examination [ Time Frame: Change from baseline DDLS on clinical examination at 12 months ] [ Designated as safety issue: No ]
    Evaluation by a glaucoma specialist

  • Disc Damage Likelihood Scale (DDLS) on stereoscopic photographs of the optic nerve [ Time Frame: Change from baseline DDLS on optic nerve photographs at 12 months ] [ Designated as safety issue: No ]
    Outcome assessed by a glaucoma specialist blinded to previous DDLS score

  • Ocular complications [ Time Frame: Post-KPro 12 months ] [ Designated as safety issue: Yes ]
    All ocular complications reported by post-KPro 12 months

  • Visual acuity [ Time Frame: Change from pre-KPro baseline visual acuity at 12 months ] [ Designated as safety issue: No ]
    Expressed in logMAR


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simultaneous implantation
Simultaneous implantation of a glaucoma drainage device at the time of Boston keratoprosthesis type 2 surgery
Device: Boston keratoprosthesis type 2
The Boston KPro, purchased from Massachusetts Eye and Ear infirmary (Boston, MA), is implanted using the usual standard technique.
Other Name: Boston KPro type 2
Device: Glaucoma drainage device
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.
Other Name: Ahmed Glaucoma Valve
Active Comparator: Implantation at post-Kpro 6 months
Implantation of a glaucoma drainage device 6 months after Boston keratoprosthesis type 2 surgery
Device: Boston keratoprosthesis type 2
The Boston KPro, purchased from Massachusetts Eye and Ear infirmary (Boston, MA), is implanted using the usual standard technique.
Other Name: Boston KPro type 2
Device: Glaucoma drainage device
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.
Other Name: Ahmed Glaucoma Valve

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Terminal glaucoma
  • Terminal retinal diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084745

Contacts
Contact: Mona Harissi-Dagher, MD, FRCSC 1-514-890-8000 ext 26354 monadagher@hotmail.com
Contact: Qianqian Wang, MD 1-514-890-8000 ext 26354 qianqian.wang1@gmail.com

Locations
Canada, Quebec
Hôpital Notre-Dame Not yet recruiting
Montreal, Quebec, Canada
Contact: Christian Eyendja    1-514-890-8000 ext 26354    christian.eyendja.chum@ssss.gouv.qc.ca   
Principal Investigator: Mona Harissi-Dagher, MD, FRCSC         
Sub-Investigator: Qianqian Wang, MD         
Sub-Investigator: Younes Agoumi, MD, FRCSC         
Sub-Investigator: Sébastien Gagné, MD, FRCSC         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Mona Harissi-Dagher, MD, FRCSC Department of Ophthalmology, Centre Hospitalier de l'Université de Montréal
  More Information

Publications:
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02084745     History of Changes
Other Study ID Numbers: CE13.277
Study First Received: February 27, 2014
Last Updated: March 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Boston keratoprosthesis
Glaucoma drainage device
Ahmed tube shunt

Additional relevant MeSH terms:
Corneal Diseases
Corneal Opacity
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on August 27, 2014