Autologous Platelet Lysate in Corneal Epithelial Defects

Hanan Jafar10 enrolled

Overview

Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Corneal Epithelial Defect

Interventions

Platelet LysateBIOLOGICAL

Eye drops of Platelet Lysate

Eligibility

Sex: ALLMin age: 21 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Cognitive ability to understand and sign the consent form. 2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops). 3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body. 4. Good compliance with the study regimen and availability for the duration of the entire study period. Exclusion Criteria: 1. Corneal ulcers which developed tissue scars. 2. Pregnant or lactating women.

Locations (1)

Cell Therapy Center

Amman, Jordan

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops

Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.

Time frame: 2 months

Secondary Outcomes

Assessment of the efficacy by clinical judgment

Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect

Time frame: 6 months

Data from ClinicalTrials.gov

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