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OpenTrials
Completed

NCT Number: NCT02875145

Impact of Cataract Surgery on Keratoplasty Graft Survival

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.

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Key information

Conditions

Cataract Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Keratoconus Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology Department, CHU Besançon

Besançon, 25030, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

Primary outcomes

  1. Corneal transplant graft survival

    Time frame: 10 years

Secondary outcomes

  1. Corneal endothelial cell density

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: IGREC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2016
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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