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

The Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers: A Randomized Clinical Trial Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909149
Enrollment
40
Registered
2025-04-03
Start date
2019-05-01
Completion date
2022-05-01
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amniotic Membrane Extract Eye Drops, Resistant Corneal Ulcers

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.

Interventions

DRUGAmniotic 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.

Patients received the specific treatment only.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time of improvement of corneal ulcers7 weeks after the procedureTime of improvement of corneal ulcers will be recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026