About this trial
Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.
However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
With aniridia
Patient weighing more than 43 kg
If the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection
If a blood donation has been made, a delay of 8 weeks must be respected after the last donation
Disqualifiers
Insufficient sample volume
No conjunctival print
HBV, HCV, HIV serology positive
Aniridia not genetically confirmed for cases For each patient excluded, a new patient will be included in order to maintain the number of patients required for data analysis.
Trial population
Aniridia patients and controls without aniridia
Trial design
Case-control
Prospective
Treatments tested in this trial
Peripheral venous blood sample
Procedure/Surgery2.5% of body weight
Conjunctival impression
Procedure/SurgeryCollection of the most superficial conjunctival epithelial cells (desquamating) in a non- or minimally invasive, quick and almost painless way, for a biological analysis of ocular surface diseases. Application of a filter paper on the bulbar conjunctiva, under local anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients
The corneal cell healing properties are evaluated by the time to reach confluence (number of hours) of epithelial cells, using a standardized wound healing assay (Incucyte, Essenbioscience). The corneal cell healing properties will be comparated between autologous serum, and plasma enriched with growth factors from blood of aniridia patients
Sponsors and contacts
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