Corneal Changes of MembranesTransCorNCT03355911
Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant
An observational study of Corneal Changes of Membranes, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Changes of Membranes
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 May 2017
- 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 Any age
- Child, Adult, Older adult
Study population: patients underwent posterior lamellar graft during the study period.
Who may be able to join
- Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:
- Fuchs dystrophy,
- pseudophakic bullous decompensation
- or other endothelial dysfunction corneal
Who cannot join
- were a history of penetrating keratoplasty in the indicated eye
- the technical inability of preoperative CCT measurement
- the need for a penetrating keratoplasty following endothelial graft failure
- severe postoperative complications resulting in unquantifiable visual acuity
About this study
Official title: Relationship Between Preoperative Corneal Thickness and Postoperative
To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
Read the detailed description
Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged > 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.
- Conditions
- Corneal Changes of Membranes
What is being measured
The primary outcome is the main question the study is designed to answer.
Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
LogMar
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Oct 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Changes of MembranesStudies of the same condition, open and under way.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355911
- Sponsor's protocol ID
- 2016-07Obs-CHRMT
- Acronym
- TransCor
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Preoperative Corneal Thickness and Postoperative
- ClinicalTrials.gov ID
- NCT03355911
- Acronym / sponsor ID
- TransCor / 2016-07Obs-CHRMT
- Conditions
- Corneal Changes of Membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 28 Nov 2017 (actual)
- 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.
To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
Detailed description
Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged > 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- patients underwent posterior lamellar graft during the study period.
Key inclusion criteria (4 listed)
- Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:
Key exclusion criteria (4 listed)
- were a history of penetrating keratoplasty in the indicated eye
- the technical inability of preoperative CCT measurement
- the need for a penetrating keratoplasty following endothelial graft failure
- severe postoperative complications resulting in unquantifiable visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
Time frame: month 6
LogMar
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 5 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Changes of Membranes, run by Centre Hospitalier Régional Metz-Thionville.
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 4 inclusion and 4 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK) (time frame: month 6). 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 5 Dec 2017.