KeratoconusRub'CorneaNCT04249180
Eye Rubbing and Keratoconus in Montpellier CHU
An observational study of Keratoconus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keratoconus
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 1 Jul 2020
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient is having a keratoconus in at least one eye. It is a deases with a primitive corneal ectasia.
Who may be able to join
- Having a keratonus at least in one eyes
Who cannot join
- Refus to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Lived Experience of the Disease of the Patients Followed at the CHU of Gui de Chauliac for a Keratoconus and Their Habit of Eye Rubbing
Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits
- Conditions
- Keratoconus
- Keywords
- primitive corneal ectasia, Ophthalmology, Eyes rubbing, Keratoconus
- Medical subject headings
- Keratoconus
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether eye rubbing is a risk factor for keratoconus
Assess whether eye rubbing is a risk factor for keratoconus
Measured: 1 day
Secondary outcomes (1)
Evaluate the habits of the population with a keratoconus
Evaluate the habits of the population with a keratoconus by a questionnaire completed by the patient
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 posted30 Jan 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: CPP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Planells, Internship of ophthalmology, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249180
- Sponsor's protocol ID
- RECHMPL20_0036
- Acronym
- Rub'Cornea
- Status last verified
- Jul 2020
- First submitted
- 28 Jan 2020
- Last updated
- 29 Jul 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Lived Experience of the Disease of the Patients Followed at the CHU of Gui de Chauliac for a Keratoconus and Their Habit of Eye Rubbing
- ClinicalTrials.gov ID
- NCT04249180
- Acronym / sponsor ID
- Rub'Cornea / RECHMPL20_0036
- Conditions
- Keratoconus
- Keywords
- primitive corneal ectasia, Ophthalmology, Eyes rubbing, Keratoconus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: CPP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 30 Jan 2020 (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.
Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient is having a keratoconus in at least one eye. It is a deases with a primitive corneal ectasia.
Key inclusion criteria (1 listed)
- Having a keratonus at least in one eyes
Key exclusion criteria (1 listed)
- Refus to participate
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
Assess whether eye rubbing is a risk factor for keratoconus
Time frame: 1 day
Assess whether eye rubbing is a risk factor for keratoconus
1 secondary outcome
Evaluate the habits of the population with a keratoconus
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Keratoconus
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
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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.
Gabriel Planells, Internship of ophthalmology principal investigator
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 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 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: withdrawn, as of the sponsor's last update on 29 Jul 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess whether eye rubbing is a risk factor for keratoconus (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 Jul 2020.