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Treatment of PED With AMT and Autologous Serum

NCT ID: NCT00238862

Last Updated: 2021-12-02

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Epithelial Defect

Keywords

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Diabetes Corneal transplant Neurotrophic keratitis Post-bacterial keratitis Metaherpetic keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amniotic membrane transplantation

Intervention Type PROCEDURE

Autologous serum/BSS 20%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Khaled Eye Specialist Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Wagoner, MD

Role: PRINCIPAL_INVESTIGATOR

King Khaled Eye Specialist Hospital

Locations

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King Khaled Eye Specialist Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RP0511-P

Identifier Type: -

Identifier Source: org_study_id