IGREC: Impact of Cataract Surgery on Keratoplasty Graft Survival

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02875145

Collaborator

(none)

453

Enrollment

Location

Duration (Months)

37.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The follow up time after keratoplasty now routinely exceeds multiple decades. It is common for keratoplasty patients to also undergo cataract surgery at a later date in their lives.

Keratoplasties and cataract surgery both result in local inflammation. This may influence the density of endothelial cells, and on average there is a loss of 10% in endothelial cells within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is required to maintain graft transparency. It may be therefore difficult to strike a balance between loss of visual acuity due to the cataract of to the loss of graft transparency over the long term.

The investigators aim to compare graft survival in patients with clear crystalline lens with and without cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract Fuchs' Endothelial Dystrophy Keratoconus	Procedure: Cataract surgery

Study Design

Study Type:

Observational

Actual Enrollment :

453 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Impact of Cataract Surgery on Keratoplasty Graft Survival

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Keratoplasty with cataract surgery Patients who underwent keratoplasty who also underwent a cataract surgery during follow up.	Procedure: Cataract surgery
Keratoplasty without cataract surgery Patients who underwent keratoplasty who never underwent cataract surgery.

Arm

Intervention/Treatment

Keratoplasty with cataract surgery

Patients who underwent keratoplasty who also underwent a cataract surgery during follow up.

Procedure: Cataract surgery

Keratoplasty without cataract surgery

Patients who underwent keratoplasty who never underwent cataract surgery.

Outcome Measures

Primary Outcome Measures

Corneal transplant graft survival [10 years]

Secondary Outcome Measures

Corneal endothelial cell density [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing keratoplasty
Between january 1983 and december 2012
Age 40 and older at the time of surgery

Exclusion Criteria:

Cataract surgery prior to the keratoplasty
Systemic inflammatory disease
Previous history of uveitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Department, CHU Besançon	Besançon		France	25030

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Bernard Delbosc, MD, PhD, Opthalmology Department, CHU Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02875145

Other Study ID Numbers:

API/2014/53

First Posted:

Aug 23, 2016

Last Update Posted:

Aug 23, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Corneal Transplantation

Graft Survival

Additional relevant MeSH terms:

Cataract

Keratoconus

Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Aug 23, 2016