Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

Phase 4

Completed

• Conditions: Cornea Ulcer
• Interventions: Biological: Autologous platelet-rich plasma (PRP) eye drops

• Registration Number: NCT05515731
• Lead Sponsor: Alaa Gamal

Brief Summary

This prospective study involved 14 patients aged \> 18 years with RCUs not responding to conventional treatment. All patients were treated with E-PRP drops (one drop), preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the treatment initiation. In each visit, the following parameters were assessed: best corrected visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva, presence of abnormal discharge and symptoms reported.

Detailed Description

The present prospective study involved 14 patients aged \> 18 years with RCUs not responding to conventional treatment. All patients were treated with E-PRP drops (one drop), preservative-free artificial tears, antibiotic eye drop four times daily and systemic vitamin A once daily for one month. All patients were examined at 1, 2, 4, 6 and 8 weeks after the treatment initiation. In each visit, the following parameters were assessed: best corrected visual acuity (BCVA), anterior segment, corneal healing, condition of the conjunctiva, presence of abnormal discharge and symptoms reported.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Resistant corneal ulcers

Exclusion Criteria

• history of topical anesthetic abuse, diagnosed with corneal dystrophies, history of neurotrophic corneal ulcers or chemical burn ulcer. Other exclusion criteria were pregnancy of systemic diseases or therapies affecting platelets count e.g. aspirin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous platelet-rich plasma eye drops	Autologous platelet-rich plasma (PRP) eye drops	Autologous platelet-rich plasma eye drops are derived from treatment of patients plasma using special process.

Primary Outcome Measures

Name	Time	Method
Pain scale	8 weeks	Corneal pain as felt by the patient according to visual analog scale

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt