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

Tanta University

Status: Completed

Conditions: Amniotic Membrane Extract Eye Drops; Resistant Corneal Ulcers

Treatments: Drug: Amniotic membrane extract eye drops; Drug: Specific treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06909149

33028/03/19

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Amniotic membrane extract eye drops group

Experimental group

Description:

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

Treatment:

Drug: Amniotic membrane extract eye drops

Control group

Active Comparator group

Description:

Patients received the specific treatment only

Treatment:

Drug: Specific treatment