Treatment of PED With AMT and Autologous Serum

King Khaled Eye Specialist Hospital180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Corneal Epithelial Defect

Interventions

Amniotic membrane transplantationPROCEDURE

Autologous serum/BSS 20%DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

King Khaled Eye Specialist Hospital

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Corneal re-epithelialization (= initial success)

Persistent corneal re-epithelialization (= lasting success)

Data from ClinicalTrials.gov

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