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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:
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 .
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:
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:
Prevalence of risk factors: a survey will measure the prevalence of risk factors for keratoconus:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abstention | Other | After keratoconus diagnosis the patient won't be assigned to intervention |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cross-linking surgery or intra corneal ring | Procedure | After keratoconus diagnosis the patient was assigned to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ABCD class worsening between consultations | At baseline and during follow-up | Baseline vs Visit at 1 month/6 months - Baseline vs 12 months - Baseline vs 24 months |
| Keratoconus histological evolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent DAIEN, PR | Contact | 0673055877 | +33 | v-daien@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent DAIEN, PR | CHU Monptellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Gui de Chauliac - Service d'Ophtamologie | Recruiting | Montpellier | Occitanie | 34295 | France |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| abstention | Other | No surgery |
|
| 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 :
| 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) | 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.
| 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 | 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. | Baseline vs Visit at 1 month/6 months/12 months/24 months |
| Risk factors - Questionnaire |
| Baseline vs 24 months |
| Tears proteomics | For 36 participants from Montpellier. Composition and evolution of tears determined by proteomic analysis | Baseline vs Visit at 1 month/6 months |
Comparison of confocal microscopy results from primary outcomes through time.
| 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. | Baseline vs Visit at 1 month/6 months |