Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

Sponsor

Alaa Gamal (Other)

Overall Status

Completed

CT.gov ID

NCT05515731

Collaborator

Al-Azhar University (Other)

Enrollment

Location

Arm

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea Ulcer	Biological: Autologous platelet-rich plasma (PRP) eye drops	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autologous platelet-rich plasma eye drops Autologous platelet-rich plasma eye drops are derived from treatment of patients plasma using special process.	Biological: Autologous platelet-rich plasma (PRP) eye drops Autologous platelet-rich plasma (PRP) eye drops are used as a sole or adjunctive therapy in many ophthalmological conditions including dry eye, macular holes, retinitis pigmentosa and perforated corneal ulcers. Actions of PRP in these conditions are attributed to the plethora of growth and healing factors concentrated in different PRP preparations.

Arm

Intervention/Treatment

Experimental: Autologous platelet-rich plasma eye drops

Autologous platelet-rich plasma eye drops are derived from treatment of patients plasma using special process.

Biological: Autologous platelet-rich plasma (PRP) eye drops

Autologous platelet-rich plasma (PRP) eye drops are used as a sole or adjunctive therapy in many ophthalmological conditions including dry eye, macular holes, retinitis pigmentosa and perforated corneal ulcers. Actions of PRP in these conditions are attributed to the plethora of growth and healing factors concentrated in different PRP preparations.

Outcome Measures

Primary Outcome Measures

Pain scale [8 weeks]
Corneal pain as felt by the patient according to visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar University	Cairo		Egypt

Sponsors and Collaborators

Alaa Gamal
Al-Azhar University

Investigators

Principal Investigator: Ahmed Gomaa, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Gamal, Al-Azhar University, Egyptian Biomedical Research Network

ClinicalTrials.gov Identifier:

NCT05515731

Other Study ID Numbers:

38983

First Posted:

Aug 25, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corneal Ulcer

Ulcer

Ophthalmic Solutions

Study Results

No Results Posted as of Aug 25, 2022