Risk Factors and Progression of Keratoconus
ConditionKeratoconus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-40
SponsorUniversity Hospital, Montpellier
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
cross-linking surgery or intra corneal ring
Procedure/SurgeryAfter keratoconus diagnosis the patient was assigned to surgery
abstention
Other interventionNo surgery
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: AbstentionOther 1 intervention
Group B: Intervention (cross-linking surgery or intra corneal ring)Other 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline vs Visit at 1 month/6 months/12 months/24 months2
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.
Time frame
Baseline vs Visit at 1 month/6 months/12 months/24 months3
Keratoconus clinical progression (Visual acuity test)
Visual acuity test with and without correction: decimal and Parinaud scales secondarily translated in LogMar.
Time frame
Baseline vs Visit at 1 month/6 months/12 months/24 months4
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)
Time frame
Baseline vs Visit at 1 month/6 months/12 months/24 monthsSecondary outcomes
1
ABCD class worsening between consultations
At baseline and during follow-up
Time frame
Baseline vs Visit at 1 month/6 months - Baseline vs 12 months - Baseline vs 24 months2
Keratoconus histological evolution
Comparison of confocal microscopy results from primary outcomes through time.
Time frame
Baseline vs Visit at 1 month/6 months3
Proteomic profile evolution
Difference between the composition of tears from healthy participants and from keratoconus patients from baseline to short term follow up.
Time frame
Baseline vs Visit at 1 month/6 monthsSponsors and contacts
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Source ClinicalTrials.gov