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

NCT06909149 | Completed

• 1 other identifier: 33028/03/19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amniotic Membrane Extract Eye Drops; Resistant Corneal Ulcers

Outcome Measures

Primary Outcomes (1)

• Time of improvement of corneal ulcers

  Time of improvement of corneal ulcers will be recorded.

  7 weeks after the procedure

Study Arms (2)

Amniotic membrane extract eye drops group

EXPERIMENTAL

Patients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment

Drug: Amniotic membrane extract eye drops

Control group

ACTIVE COMPARATOR

Patients received the specific treatment only

Drug: Specific treatment

Interventions

Amniotic membrane extract eye drops DRUG

Patients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment.

Amniotic membrane extract eye drops group

Specific treatment DRUG

Patients received the specific treatment only.

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)