Corneal DiseasesKCDTRNCT04164407
Keratoconus, Corneal Diseases and Transplant Registry
An observational study of Corneal Diseases and Keratoconus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Diseases, Keratoconus, Corneal Ulcer
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 30 Dec 2021
- 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 with corneal disease, including keratoconus and / or corneal transplant.
Who may be able to join
- Suffering from a corneal disease
- Undergoing treatment in the Ophthalmology department of the CHU Montpellier
- Has been presented with an Opt-Out consent form
Who cannot join
- Expressed a desire to not be included in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Vincent Daien, MD, PhD, HDR, 67336966 ext. 33, v-daien@chu-montpellier.fr
Hannah Crowdy, 7335663 ext. 33, h-crowdy@chu-montpellier.fr
About this study
Official title: Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)
The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent.
Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25.
Read more
This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice.
A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.
•Methods:
Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier.
A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice.
This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become.
•Discussion:
The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care.
In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.
- Keywords
- Pseudophakic and aphakic bullous keratopathy, Ophthalmology, Cornea, Keratoconus, Cornea transplant, Corneal dystrophies, Crosslinking
- Medical subject headings
- Corneal Diseases, Keratoconus, Corneal Ulcer, Corneal Injuries, Corneal Dystrophies, Hereditary
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual Acuity
Measured: 1 day
Secondary outcomes (1)
Treatment(s) received
Treatment(s) received
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Daien, MD, PhD, HDR, Study director, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164407
- Sponsor's protocol ID
- RECHMPL19_0500
- Acronym
- KCDTR
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)
- ClinicalTrials.gov ID
- NCT04164407
- Acronym / sponsor ID
- KCDTR / RECHMPL19_0500
- Keywords
- Pseudophakic and aphakic bullous keratopathy, Ophthalmology, Cornea, Keratoconus, Cornea transplant, Corneal dystrophies, Crosslinking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Nov 2019 (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 cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent.
Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25.
This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice.
A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.
•Methods:
Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier.
A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice.
This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become.
•Discussion:
The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care.
In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.
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 with corneal disease, including keratoconus and / or corneal transplant.
Key inclusion criteria (3 listed)
- Suffering from a corneal disease
- Undergoing treatment in the Ophthalmology department of the CHU Montpellier
- Has been presented with an Opt-Out consent form
Key exclusion criteria (1 listed)
- Expressed a desire to not be included in the study
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
Visual Acuity
Time frame: 1 day
Visual Acuity
1 secondary outcome
Treatment(s) received
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Vincent Daien, MD, PhD, HDR study director
University Hospitals of Montpellier
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 Corneal Diseases and Keratoconus, run by University Hospital, Montpellier 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 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Daien, MD, PhD, HDR (67336966 ext. 33, v-daien@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 1 day). 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 29 Dec 2020.