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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

NCT01075347

Corneal Epithelial Defect Diabetic Retinopathy Penetrating Keratoplasty

COMPLETED PHASE1

Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

NCT05321251

Neurotrophic Keratitis

WITHDRAWN PHASE2/PHASE3

Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy

NCT00915759

Corneal Wound Healing

COMPLETED NA

An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops

NCT04293549

Neurotrophic Keratopathy

COMPLETED

Corneal Neurotization as a Treatment for Neurotrophic Keratopathy

NCT05809245

Neurotrophic Corneal Ulcer Neurotrophic Keratitis Cranial Nerve V Diseases

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies.

A conjunctival impression will also be taken at the inclusion of the patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aniridia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case patients with aniridia

Peripheral venous blood sample

Intervention Type PROCEDURE

2.5% of body weight

Conjunctival impression

Intervention Type 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.

Control patients without aniridia

Peripheral venous blood sample

Intervention Type PROCEDURE

2.5% of body weight

Conjunctival impression

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peripheral venous blood sample

2.5% of body weight

Intervention Type PROCEDURE

Conjunctival impression

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes