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

NCT05400590 | Recruiting

• 2 other identifiers: DGT_2022_22022-A00259-34
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aniridia

Keywords

Growth factor rich plasma; Conjunctival impression

Outcome Measures

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

  Sampling done at baseline

Study Arms (2)

Case patients with aniridia

Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression

Control patients without aniridia

Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression

Interventions

Peripheral venous blood sample PROCEDURE

2.5% of body weight

Case patients with aniridia; Control patients without aniridia

Conjunctival impression PROCEDURE

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.

Case patients with aniridia; Control patients without aniridia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aniridia patients and controls without aniridia

You may qualify if:

• For patients with aniridia:
• 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
• For controls:
• Non-aniridia (no clinical signs)
• Weighing more than 43 kg
• Matched to a case for sex and age +/-10 years
• No known diabetes
• If a blood donation has been made, a delay of 8 weeks must be respected after the latter

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Aniridia

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Eye Diseases, Hereditary; Iris Diseases; Uveal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Eric GABISON

  Hôpital Fondation A. de Rothschild

  STUDY CHAIR

• Damien GUINDOLET

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YAVCHITZ

CONTACT

(0)1 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: May 15, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)