Impact of Cataract Surgery on Keratoplasty Graft Survival (IGREC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02875145|
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
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|
|Cataract Fuchs' Endothelial Dystrophy Keratoconus||Procedure: Cataract surgery|
|Study Type :||Observational|
|Actual Enrollment :||453 participants|
|Official Title:||Impact of Cataract Surgery on Keratoplasty Graft Survival|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
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.
- Corneal transplant graft survival [ Time Frame: 10 years ]
- Corneal endothelial cell density [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875145
|Ophthalmology Department, CHU Besançon|
|Besançon, France, 25030|
|Principal Investigator:||Bernard Delbosc, MD, PhD||Opthalmology Department, CHU Besançon|