Impact of Cataract Surgery on Keratoplasty Graft Survival

NCT02875145 | Completed

• 1 other identifier: API/2014/53
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Fuchs' Endothelial Dystrophy; Keratoconus

Keywords

Corneal Transplantation; Graft Survival

Outcome Measures

Primary Outcomes (1)

• Corneal transplant graft survival

  10 years

Secondary Outcomes (1)

• Corneal endothelial cell density

  10 years

Study Arms (2)

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.

Interventions

Cataract surgery PROCEDURE

Keratoplasty with cataract surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent a keratoplasty between january 1983 and december 2012 at the University Hospital of Besançon.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Ophthalmology Department, CHU Besançon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Cataract; Fuchs' Endothelial Dystrophy; Keratoconus

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bernard Delbosc, MD, PhD

  Opthalmology Department, CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 23, 2016
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 23, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)