NCT01950598

Brief Summary

The purpose of this study is to determine whether frozen corneas are as safe and effective as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long term follow-up. Corneal transplantation is typically performed using fresh, transparent corneas. With KPro surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent as fresh grafts when used as carrier for the KPro.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

7.2 years

First QC Date

September 9, 2013

Last Update Submit

January 26, 2021

Conditions

Corneal BlindnessBoston Keratoprosthesis Type I Candidate

Keywords

Boston Keratoprosthesis type I surgery, frozen corneal graft

Outcome Measures

Primary Outcomes (1)

  • Extrusion rate

    10 years post-KPro implantation

Secondary Outcomes (5)

  • Best-corrected visual acuity

    10 years

  • Retroprosthetic membrane formation

    10 years

  • Endophthalmitis rate

    10 years

  • Sterile vitritis rate

    10 years

  • Intraoperative complications

    time of surgery

Study Arms (2)

Fresh carrier graft for KPro

ACTIVE COMPARATOR

KPro implanted using fresh cornea, preserved in optisol GS

Procedure: Boston KPro type I - fresh graft

Frozen carrier graft for KPro

EXPERIMENTAL

KPro implanted using frozen cornea, which was supplied as a whole globe cryopreserved at -80°C in gramicidin 0.025 mg/mL and polymyxin B sulfate 10 000 U/mL ophthalmic solution.

Procedure: Boston KPro type I surgery - frozen graft

Interventions

Boston KPro type I - fresh graftPROCEDURE

Boston KPro mounted on fresh corneal carrier graft for implantation

Fresh carrier graft for KPro
Boston KPro type I surgery - frozen graftPROCEDURE

Boston KPro mounted on frozen corneal carrier graft for implantation

Frozen carrier graft for KPro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subject over age 18 years
  • Boston KPro type I indicated
  • history, slit-lamp findings and B-scan do not suggest endstage glaucoma or significant posterior segment disease
  • Sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
  • Able to administer eye medications or have a care-giver able and willing to do the same
  • Corneal blindness with poor prognosis for survival of a traditional penetrating keratoplasty

You may not qualify if:

  • Subject under age 18 years
  • History, slit-lamp findings and B-scan suggest endstage glaucoma or significant posterior segment disease
  • Not sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
  • Unable to administer eye medication or does not have a care-giver willing to do the same

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • Robert MC, Biernacki K, Harissi-Dagher M. Boston keratoprosthesis type 1 surgery: use of frozen versus fresh corneal donor carriers. Cornea. 2012 Apr;31(4):339-45. doi: 10.1097/ICO.0b013e31823e6110.

    PMID: 22269678RESULT

Study Officials

  • Mona Harissi-Dagher, M.D.

    CHUM - Hôpital Notre-Dame

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, FRSCS

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

CA(1)