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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Cataract Fuchs' Endothelial Dystrophy Keratoconus Procedure: Cataract surgery

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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 : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort 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.



Primary Outcome Measures :
  1. Corneal transplant graft survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Corneal endothelial cell density [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Ophthalmology Department, CHU Besançon
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Bernard Delbosc, MD, PhD Opthalmology Department, CHU Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02875145    
Other Study ID Numbers: API/2014/53
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Corneal Transplantation
Graft Survival
Additional relevant MeSH terms:
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Cataract
Keratoconus
Fuchs' Endothelial Dystrophy
Lens Diseases
Eye Diseases
Corneal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn