CataractCISIPHENCT03355924
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure
An observational study of Cataract and Corneal Graft, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Corneal Graft
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent DMEK combined or not with cataract surgery
Who may be able to join
- patients who underwent DMEK combined or not with cataract surgery
Who cannot join
- patients with other ocular comorbidity, and those who had graft after a first graft failure
About this study
The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure
Read the detailed description
The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.
- Conditions
- Cataract, Corneal Graft
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Best visual acuity
logMar
Measured: Month 12
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 Nov 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 CataractStudies 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
- 31 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
- NCT03355924
- Sponsor's protocol ID
- 2016-08Obs-CHRMT
- Acronym
- CISIPHE
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure
- ClinicalTrials.gov ID
- NCT03355924
- Acronym / sponsor ID
- CISIPHE / 2016-08Obs-CHRMT
- Conditions
- Cataract, Corneal Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Nov 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.
The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure
Detailed description
The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent DMEK combined or not with cataract surgery
Key inclusion criteria (1 listed)
- patients who underwent DMEK combined or not with cataract surgery
Key exclusion criteria (1 listed)
- patients with other ocular comorbidity, and those who had graft after a first graft failure
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
Best visual acuity
Time frame: Month 12
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 24 Aug 2023.
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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 Cataract and Corneal Graft, 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 1 inclusion and 1 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 24 Aug 2023. 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?
Best visual acuity (time frame: Month 12). 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 24 Aug 2023.