Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers

Not Applicable

Completed

• Conditions: Amniotic Membrane Extract Eye Drops; Resistant Corneal Ulcers
• Interventions: Drug: Amniotic membrane extract eye drops; Drug: Specific treatment

• Registration Number: NCT06909149
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers.

Detailed Description

Corneal ulceration is one of the leading causes of corneal blindness. Multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions.

Amniotic membrane (AM) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, A variety of matrix proteins, in addition to anti-microbial effect. Inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely.

Researchers found that amniotic membrane extract eye drops (AMEED) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age from 20 to 80 years.
• Both sexes.
• Patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention.

Exclusion Criteria

• Severe corneal melting.
• Perforated corneal ulcer.
• Corneal ulcers with significant thinning with or without descemetocele.
• Patients who were unable to adhere to the treatment plan properly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic membrane extract eye drops group	Amniotic membrane extract eye drops	Patients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment
Control group	Specific treatment	Patients received the specific treatment only

Primary Outcome Measures

Name	Time	Method
Time of improvement of corneal ulcers	7 weeks after the procedure	Time of improvement of corneal ulcers will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt