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Completed

NCT Number: NCT05515731

Platelet Rich Plasma as a Treatment For Resistant Corneal Ulcers

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.

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Key information

Conditions

Cornea Ulcer Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections Keratitis

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Azhar University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous platelet-rich plasma (PRP) eye drops

Biological

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 outcomes

  1. Pain scale

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Alaa Gamal

Network

Collaborators

  • Al-Azhar University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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