CataractIGRECNCT02875145
Impact of Cataract Surgery on Keratoplasty Graft Survival
An observational study of Cataract and Fuchs' Endothelial Dystrophy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract, Fuchs' Endothelial Dystrophy, Keratoconus
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 453 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent a keratoplasty between january 1983 and december 2012 at the University Hospital of Besançon.
Who may be able to join
- All patients undergoing keratoplasty
- Between january 1983 and december 2012
- Age 40 and older at the time of surgery
Who cannot join
- Cataract surgery prior to the keratoplasty
- Systemic inflammatory disease
- Previous history of uveitis
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cataract surgery
- Keywords
- Corneal Transplantation, Graft Survival
- Medical subject headings
- Cataract, Fuchs' Endothelial Dystrophy, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Keratoplasty with cataract surgery | Patients who underwent keratoplasty who also underwent a cataract surgery during follow up. Receives: Procedure: Cataract surgery | |
| Keratoplasty without cataract surgery | Patients who underwent keratoplasty who never underwent cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal transplant graft survival
Measured: 10 years
Secondary outcomes (1)
Corneal endothelial cell density
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Delbosc, MD, PhD, Principal investigator, Opthalmology Department, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875145
- Sponsor's protocol ID
- API/2014/53
- Acronym
- IGREC
- Status last verified
- Aug 2016
- First submitted
- 28 Jul 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cataract Surgery on Keratoplasty Graft Survival
- ClinicalTrials.gov ID
- NCT02875145
- Acronym / sponsor ID
- IGREC / API/2014/53
- Conditions
- Cataract, Fuchs' Endothelial Dystrophy, Keratoconus
- Keywords
- Corneal Transplantation, Graft Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keratoplasty with cataract surgery | – | Procedure: Cataract surgeryPatients who underwent keratoplasty who also underwent a cataract surgery during follow up. |
| Keratoplasty without cataract surgery | – | –Patients who underwent keratoplasty who never underwent cataract surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent a keratoplasty between january 1983 and december 2012 at the University Hospital of Besançon.
Key inclusion criteria (3 listed)
- All patients undergoing keratoplasty
- Between january 1983 and december 2012
- Age 40 and older at the time of surgery
Key exclusion criteria (3 listed)
- Cataract surgery prior to the keratoplasty
- Systemic inflammatory disease
- Previous history of uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery | Procedure or surgery | Keratoplasty with cataract surgery |
Primary outcome
Corneal transplant graft survival
Time frame: 10 years
1 secondary outcome
Corneal endothelial cell density
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Delbosc, MD, PhD principal investigator
Opthalmology Department, CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Fuchs' Endothelial Dystrophy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal transplant graft survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.