Impact of Cataract Surgery on Keratoplasty Graft Survival

Completed

• Conditions: Cataract; Fuchs' Endothelial Dystrophy; Keratoconus
• Interventions: Procedure: Cataract surgery

• Registration Number: NCT02875145
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-07-28
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Keratoplasty with cataract surgery	Cataract surgery	Patients who underwent keratoplasty who also underwent a cataract surgery during follow up.

Primary Outcome Measures

Name	Time	Method
Corneal transplant graft survival	10 years

Secondary Outcome Measures

Name	Time	Method
Corneal endothelial cell density	10 years

Trial Locations

Locations (1)

Ophthalmology Department, CHU Besançon; 🇫🇷 Besançon, France