KeratoconusFRPKNCT05676580
Risk Factors and Progression of Keratoconus
A study testing cross-linking surgery or intra corneal ring and abstention in people with Keratoconus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Primary objective : Description of keratoconus at baseline and during progression in 200 participants followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- cross-linking surgery or intra corneal ring and abstention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2023to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants with clinical keratoconus (Rabinowitz criteria with topographic slit lamp abnormalities and visual impairment), preclinical or crude keratoconus (abnormal or suspicious topography with normal slit lamp examination and normal visual acuity, visual acuity)
- Followed by the ophthalmology services of the CHU Montpellier, CHU Bordeaux or CHU Toulouse
- For adult Participants: collection of written informed consent, after a period of reflection period
- For minors: informed consent signed by at least one of the 2 parents or legal representatives legal representatives, and assent of the child after a period of reflection
- Affiliation to the French social security system or beneficiary of such a system
Who cannot join
- Person under legal supervision, guardianship or curator
- History of corneal implant on both eyes
- Planned relocation before the end of the first stage of treatment (abstention, cross-linking, intra-corneal ring depending on the participant)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Gui de Chauliac - Service d'Ophtamologie
Montpellier, Occitanie, 34295
Vincent DAIEN, Pr, v-daien@chu-montpellier.fr
Vincent Daien, Pr
About this study
Primary objective :
Description of keratoconus at baseline and during progression in 200 participants followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. Clinical outcome, histology of the cornea and tears proteomics will be assessed in 4 groups at different points in time:
Read more
- At 6 months in participants with no intervention (risk reduction instructions: not to rub their eyes)
- At 6 months in participants with no intervention that didn't comply with the risk reduction instructions
- At 1 month in participants assigned to cross-linking surgery
- At 1 month in participants assigned to intra corneal ring surgery If both eyes are affected, both will be evaluated with their own visit agenda. Visits for no surgery participants will be set at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction).
Visits for surgery participants will be set at D7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring.
Secondary objective :
Description of the association between clinical outcomes, histological progression of the cornea and tears proteomics in time, 2 years period.
Comparison of tears proteomics in 36 participants with keratoconus followed at CHU of Montpellier and healthy participants at baseline .
Read the detailed description
This trial is a prospective cohort study of 200 participants with keratoconus followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. If both eyes are affected, each will be evaluated considering their own visit agenda. Histological and proteomic evaluations will be performed in 36 participants's eyes whose initial management is abstention of surgery (12 participants), cross-linking (12 participants) or intra corneal ring (12 participants).
The target population consist of participants with clinical keratoconus (topographic Rabinowitz criteria with slit lamp abnormalities and visual impairment), preclinical or crude keratoconus (abnormal or suspicious topography with normal slit lamp examination and normal visual acuity). They will be aged between 10 and 40 years included.
The follow-up will be taken care off by the ophthalmology departments of the Montpellier University Hospital, Bordeaux University Hospital or Toulouse University Hospital Collection of written informed consent, after a period of reflection, will be necessary for adult participants. For minors: informed consent will have to be signed by at least one of the 2 parents or legal guardians, and approval from the child will be asked after a period of reflection. All participants will have to be affiliated to the French social security system or beneficiary of such a system.
Description of the study course:
No therapeutic intervention outside of routine care will be performed. Depending on the therapeutic orientation, the follow-up is carried out as follows:
- Visits at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction management).
- Visits at day 7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring.
In this study, participants will be followed for a maximum of 2.5 years. In addition to the description of keratoconus progression, we will take a tear sample using the Schirmer test to create a biobank. This tears collection will be performed in 36 participants followed at the Montpellier University Hospital, at inclusion and at short-term follow-up visit (6 months if abstention, 1 month if surgery).
Judging criteria:
- Paraclinical examination of the participants
- Ophthalmological paraclinical data
- Confocal microscopy examination
- ABCD classification of keratoconus
- Composition and evolution of tears determined by proteomic analysis
- Survey on risk factors: allergies, atopy, ocular friction, family history, ethnic origin, smoking, dry eye syndrome, low pachymetry
Prevalence of risk factors: a survey will measure the prevalence of risk factors for keratoconus:
- Presence of atopy/allergy
- Eye rubs
- Family history
- Ethnic origin
- Tobacco use
- Dry eye syndrome (survey + clinical examination)
- Low pachymetry
This self-survey will be completed at the inclusion visit and at the last follow-up visit (M24). The time to complete this questionnaire is approximately 10 minutes.
- Conditions
- Keratoconus
- Being tested
- cross-linking surgery or intra corneal ring, abstention
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-linking surgery or intra corneal ringProcedure or surgery
After keratoconus diagnosis the patient was assigned to surgery
abstentionOther
No surgery
| Study group | Role | What they receive |
|---|---|---|
| Abstention | Other | After keratoconus diagnosis the patient won't be assigned to intervention Receives: Other: abstention |
| Intervention (cross-linking surgery or intra corneal ring) | Other | After keratoconus diagnosis the patient was assigned to cross linking surgery or intra corneal ring surgery Receives: Procedure: cross-linking surgery or intra corneal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratoconus clinical progression (Keratometry map)
Modelisation of refraction measurements in diopters, by corneal elevation topography (Orbscan and Pentacam), giving an additional indicator of the corneal deformity. High values of diopter correspond to positive bulges of the cornea. A topographic axial map will be acquired to monitor minimal and maximal keratometry.
These measurements will be taken at baseline and compared for reference of progression at each visit for each eye.
Keratoconus definition according to Rabinowitz (Rabinowitz YS, 1989) criteria:
- Corneal asymmetry greater than 1.5 diopters (D), between the upper and lower part of the cornea, on the median vertical axis.
- Central corneal power (Kmax) > 47.2 D, measured at the top of the cone.
- Asymmetry of central keratometry > 1D between the two eyes
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus clinical progression (Pachymetric map)
Thickness of the cornea will be assessed in microns (µm) at several locations and will be presented as a map by corneal elevation topography (Orbscan and Pentacam).
The pachymetric map will be acquired at baseline and compared for reference of progression at each visit for each eye. The higher and lower thickness points will be notified for the anterior and posterior parts of the eye.
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus clinical progression (Visual acuity test)
Visual acuity test with and without correction: decimal and Parinaud scales secondarily translated in LogMar.
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus clinical progression (Biomicroscopic examination of the cornea)
A biomicroscopic examination of the cornea in search of signs that may modify the therapeutic indications i.e : Fleischer rings (iron deposits in the lower part of the bulge, due to the stagnation of tears), visible corneal nerves, corneal opacities (due to scar tissue)
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
ABCD grading of keratoconus
Grading of the keratoconus, according to the ABCD classification :
- A: keratometry of the anterior surface of the cornea (Anterior radius of curvature (ARC)), in the area of 3 mm centered by the thinnest point.
- B: keratometry of the posterior surface of the cornea (Back or posterior radius of curvature PRC), in the 3mm area centered by the thinnest point.
- C: thinnest point of the Cornea, i.e. minimum pachymetry.
- D: Distance best corrected vision: visual acuity with the best correction, measured in 10° or in the Parinaud scale.
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus histological progression - Confocal microscopy (tissue thickness)
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects.
Tissue thickness in microns (µm)
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus histological progression - Confocal microscopy (Cellular organization)
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects.
Cell organization and morphology. Image acquisition.
- Colonization by inflammatory cells (yes/no), increased nucleo/cytoplasmic ratio (yes/no), hyperreflectivity of the nuclei (yes/no).
- Nerve density of the basal plexuses of normal appearance (yes/no), straight with branches (yes/no), normal hyperreflectivity (yes/no)
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus histological progression - Confocal microscopy (Cellular density)
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects.
Cellular density (number). Image acquisition.
- Cell count in the different layers, corneal nerve count from the basal plexus to the corneal apex
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Keratoconus histological progression - Confocal microscopy (Light scattering)
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects.
Light scattering in vivo, measurement of corneal deformity. Diopter.
Measured: Baseline vs Visit at 1 month/6 months/12 months/24 months
Risk factors - Questionnaire
- Presence of atopy/allergy
- Eye rubbing
- Family medical history
- Ethnicity
- Smoking habits
- Dry eye syndrome
Measured: Baseline vs 24 months
Tears proteomics
For 36 participants from Montpellier. Composition and evolution of tears determined by proteomic analysis
Measured: Baseline vs Visit at 1 month/6 months
Secondary outcomes (3)
ABCD class worsening between consultations
At baseline and during follow-up
Measured: Baseline vs Visit at 1 month/6 months - Baseline vs 12 months - Baseline vs 24 months
Keratoconus histological evolution
Comparison of confocal microscopy results from primary outcomes through time.
Measured: Baseline vs Visit at 1 month/6 months
Proteomic profile evolution
Difference between the composition of tears from healthy participants and from keratoconus patients from baseline to short term follow up.
Measured: Baseline vs Visit at 1 month/6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start5 Jun 2023
- Primary completion5 Jun 2027 (estimated)
- Study completionMay 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent DAIEN, PR, Principal investigator, CHU Monptellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676580
- Sponsor's protocol ID
- RECHMPL20_0450 / UF8090
- Acronym
- FRPK
- Status last verified
- Aug 2025
- First submitted
- 18 Dec 2022
- Last updated
- 5 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Progression of Keratoconus
- ClinicalTrials.gov ID
- NCT05676580
- Acronym / sponsor ID
- FRPK / RECHMPL20_0450 / UF8090
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Jan 2023 (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.
Primary objective :
Description of keratoconus at baseline and during progression in 200 participants followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. Clinical outcome, histology of the cornea and tears proteomics will be assessed in 4 groups at different points in time:
- At 6 months in participants with no intervention (risk reduction instructions: not to rub their eyes)
- At 6 months in participants with no intervention that didn't comply with the risk reduction instructions
- At 1 month in participants assigned to cross-linking surgery
- At 1 month in participants assigned to intra corneal ring surgery If both eyes are affected, both will be evaluated with their own visit agenda. Visits for no surgery participants will be set at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction).
Visits for surgery participants will be set at D7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring.
Secondary objective :
Description of the association between clinical outcomes, histological progression of the cornea and tears proteomics in time, 2 years period.
Comparison of tears proteomics in 36 participants with keratoconus followed at CHU of Montpellier and healthy participants at baseline .
Detailed description
This trial is a prospective cohort study of 200 participants with keratoconus followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. If both eyes are affected, each will be evaluated considering their own visit agenda. Histological and proteomic evaluations will be performed in 36 participants's eyes whose initial management is abstention of surgery (12 participants), cross-linking (12 participants) or intra corneal ring (12 participants).
The target population consist of participants with clinical keratoconus (topographic Rabinowitz criteria with slit lamp abnormalities and visual impairment), preclinical or crude keratoconus (abnormal or suspicious topography with normal slit lamp examination and normal visual acuity). They will be aged between 10 and 40 years included.
The follow-up will be taken care off by the ophthalmology departments of the Montpellier University Hospital, Bordeaux University Hospital or Toulouse University Hospital Collection of written informed consent, after a period of reflection, will be necessary for adult participants. For minors: informed consent will have to be signed by at least one of the 2 parents or legal guardians, and approval from the child will be asked after a period of reflection. All participants will have to be affiliated to the French social security system or beneficiary of such a system.
Description of the study course:
No therapeutic intervention outside of routine care will be performed. Depending on the therapeutic orientation, the follow-up is carried out as follows:
- Visits at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction management).
- Visits at day 7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring.
In this study, participants will be followed for a maximum of 2.5 years. In addition to the description of keratoconus progression, we will take a tear sample using the Schirmer test to create a biobank. This tears collection will be performed in 36 participants followed at the Montpellier University Hospital, at inclusion and at short-term follow-up visit (6 months if abstention, 1 month if surgery).
Judging criteria:
- Paraclinical examination of the participants
- Ophthalmological paraclinical data
- Confocal microscopy examination
- ABCD classification of keratoconus
- Composition and evolution of tears determined by proteomic analysis
- Survey on risk factors: allergies, atopy, ocular friction, family history, ethnic origin, smoking, dry eye syndrome, low pachymetry
Prevalence of risk factors: a survey will measure the prevalence of risk factors for keratoconus:
- Presence of atopy/allergy
- Eye rubs
- Family history
- Ethnic origin
- Tobacco use
- Dry eye syndrome (survey + clinical examination)
- Low pachymetry
This self-survey will be completed at the inclusion visit and at the last follow-up visit (M24). The time to complete this questionnaire is approximately 10 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstention | Other | Other: abstentionAfter keratoconus diagnosis the patient won't be assigned to intervention |
| Intervention (cross-linking surgery or intra corneal ring) | Other | Procedure: cross-linking surgery or intra corneal ringAfter keratoconus diagnosis the patient was assigned to cross linking surgery or intra corneal ring surgery |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants with clinical keratoconus (Rabinowitz criteria with topographic slit lamp abnormalities and visual impairment), preclinical or crude keratoconus (abnormal or suspicious topography with normal slit lamp examination and normal visual acuity, visual acuity)
- Followed by the ophthalmology services of the CHU Montpellier, CHU Bordeaux or CHU Toulouse
- For adult Participants: collection of written informed consent, after a period of reflection period
- For minors: informed consent signed by at least one of the 2 parents or legal representatives legal representatives, and assent of the child after a period of reflection
- Affiliation to the French social security system or beneficiary of such a system
Key exclusion criteria (3 listed)
- Person under legal supervision, guardianship or curator
- History of corneal implant on both eyes
- Planned relocation before the end of the first stage of treatment (abstention, cross-linking, intra-corneal ring depending on the participant)
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 |
|---|---|---|
| cross-linking surgery or intra corneal ringAfter keratoconus diagnosis the patient was assigned to surgery | Procedure or surgery | Intervention (cross-linking surgery or intra corneal ring) |
| abstentionNo surgery | Other | Abstention |
Primary outcome
Keratoconus clinical progression (Keratometry map)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Modelisation of refraction measurements in diopters, by corneal elevation topography (Orbscan and Pentacam), giving an additional indicator of the corneal deformity. High values of diopter correspond to positive bulges of the cornea. A topographic axial map will be acquired to monitor minimal and maximal keratometry. These measurements will be taken at baseline and compared for reference of progression at each visit for each eye. Keratoconus definition according to Rabinowitz (Rabinowitz YS, 1989) criteria: * Corneal asymmetry greater than 1.5 diopters (D), between the upper and lower part of the cornea, on the median vertical axis. * Central corneal power (Kmax) > 47.2 D, measured at the top of the cone. * Asymmetry of central keratometry > 1D between the two eyes
Keratoconus clinical progression (Pachymetric map)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Thickness of the cornea will be assessed in microns (µm) at several locations and will be presented as a map by corneal elevation topography (Orbscan and Pentacam). The pachymetric map will be acquired at baseline and compared for reference of progression at each visit for each eye. The higher and lower thickness points will be notified for the anterior and posterior parts of the eye.
Keratoconus clinical progression (Visual acuity test)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Visual acuity test with and without correction: decimal and Parinaud scales secondarily translated in LogMar.
Keratoconus clinical progression (Biomicroscopic examination of the cornea)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
A biomicroscopic examination of the cornea in search of signs that may modify the therapeutic indications i.e : Fleischer rings (iron deposits in the lower part of the bulge, due to the stagnation of tears), visible corneal nerves, corneal opacities (due to scar tissue)
ABCD grading of keratoconus
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Grading of the keratoconus, according to the ABCD classification : * A: keratometry of the anterior surface of the cornea (Anterior radius of curvature (ARC)), in the area of 3 mm centered by the thinnest point. * B: keratometry of the posterior surface of the cornea (Back or posterior radius of curvature PRC), in the 3mm area centered by the thinnest point. * C: thinnest point of the Cornea, i.e. minimum pachymetry. * D: Distance best corrected vision: visual acuity with the best correction, measured in 10° or in the Parinaud scale.
Keratoconus histological progression - Confocal microscopy (tissue thickness)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects. Tissue thickness in microns (µm)
Keratoconus histological progression - Confocal microscopy (Cellular organization)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects. Cell organization and morphology. Image acquisition. * Colonization by inflammatory cells (yes/no), increased nucleo/cytoplasmic ratio (yes/no), hyperreflectivity of the nuclei (yes/no). * Nerve density of the basal plexuses of normal appearance (yes/no), straight with branches (yes/no), normal hyperreflectivity (yes/no)
Keratoconus histological progression - Confocal microscopy (Cellular density)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects. Cellular density (number). Image acquisition. - Cell count in the different layers, corneal nerve count from the basal plexus to the corneal apex
Keratoconus histological progression - Confocal microscopy (Light scattering)
Time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months
Histological degradation of the cornea taken at baseline for reference. The confocal microscope allows longitudinal analysis making it possible to carry out comparative qualitative and quantitative analyzes of the corneal tissue during time. In keratoconus, this technique is possible to highlight a reduction in basal plexus nerve density and poorer anterior stromal cell density compared to healthy subjects. Light scattering in vivo, measurement of corneal deformity. Diopter.
Risk factors - Questionnaire
Time frame: Baseline vs 24 months
* Presence of atopy/allergy * Eye rubbing * Family medical history * Ethnicity * Smoking habits * Dry eye syndrome
Tears proteomics
Time frame: Baseline vs Visit at 1 month/6 months
For 36 participants from Montpellier. Composition and evolution of tears determined by proteomic analysis
3 secondary outcomes
ABCD class worsening between consultations
Time frame: Baseline vs Visit at 1 month/6 months - Baseline vs 12 months - Baseline vs 24 months
Keratoconus histological evolution
Time frame: Baseline vs Visit at 1 month/6 months
Proteomic profile evolution
Time frame: Baseline vs Visit at 1 month/6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- 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.
Vincent DAIEN, PR principal investigator
CHU Monptellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cross-linking surgery or intra corneal ring and abstention in people with 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 5 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent DAIEN, PR (0673055877 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?
Keratoconus clinical progression (Keratometry map) (time frame: Baseline vs Visit at 1 month/6 months/12 months/24 months). The study lists 11 primary outcomes in all. 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 Sep 2025.