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Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

Primary Purpose

Cornea Ulcer

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Autologous platelet-rich plasma (PRP) eye drops
Sponsored by
Alaa Gamal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cornea Ulcer

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Al-Azhar University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous platelet-rich plasma eye drops

Arm Description

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

Outcomes

Primary Outcome Measures

Pain scale
Corneal pain as felt by the patient according to visual analog scale

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
August 23, 2022
Sponsor
Alaa Gamal
Collaborators
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05515731
Brief Title
Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers
Official Title
Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Gamal
Collaborators
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous platelet-rich plasma eye drops
Arm Type
Experimental
Arm Description
Autologous platelet-rich plasma eye drops are derived from treatment of patients plasma using special process.
Intervention Type
Biological
Intervention Name(s)
Autologous platelet-rich plasma (PRP) eye drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scale
Description
Corneal pain as felt by the patient according to visual analog scale
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gomaa
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

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