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

NCT ID: NCT06909149

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Amniotic Membrane Extract Eye Drops Resistant Corneal Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amniotic membrane extract eye drops group

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

Group Type EXPERIMENTAL

Amniotic membrane extract eye drops

Intervention Type DRUG

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

Patients received the specific treatment only

Group Type ACTIVE_COMPARATOR

Specific treatment

Intervention Type DRUG

Patients received the specific treatment only.

Interventions

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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.

Intervention Type DRUG

Specific treatment

Patients received the specific treatment only.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Sameh El-Shorbagy

Assistant Lecturer of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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33028/03/19

Identifier Type: -

Identifier Source: org_study_id

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