Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients

ConditionAniridia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Peripheral venous blood sample

    Procedure/Surgery

    2.5% of body weight

  • Conjunctival impression

    Procedure/Surgery

    Collection 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

24 Participants
are divided into 2 treatment groups
Group A: Case patients with aniridia2 interventions
Group B: Control patients without aniridia2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Sampling done at baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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