Treatment of PED With AMT and Autologous Serum

Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238862

Enrollment

180

Registered

2005-10-14

Start date

2005-10-31

Completion date

2006-09-30

Last updated

2021-12-02

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

Conditions

Corneal Epithelial Defect

Keywords

Diabetes, Corneal transplant, Neurotrophic keratitis, Post-bacterial keratitis, Metaherpetic keratitis

Brief summary

Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.

Interventions

PROCEDUREAmniotic membrane transplantation

DRUGAutologous serum/BSS 20%

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Corneal epithelial defect of more than 14 days that has not responded to conventional therapy

Exclusion criteria

* Under age 18 * Pregnant/lactating females * Patients with hemoglobin levels \< 12 mg/ml * Patients with limbal stem cell deficiency

Design outcomes

Primary

Measure	Time frame
Corneal re-epithelialization (= initial success)	—
Persistent corneal re-epithelialization (= lasting success)	—

Countries

Saudi Arabia

Outcome results

None listed

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