Treatment of PED With AMT and Autologous Serum

This study has been completed.

First Received: October 12, 2005 Last Updated: March 5, 2007 History of Changes

Sponsored by:	King Khaled Eye Specialist Hospital
Information provided by:	King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier:	NCT00238862

Purpose

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.

Condition	Intervention
Corneal Epithelial Defect	Procedure: Amniotic membrane transplantation Drug: Autologous serum/BSS 20%

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Further study details as provided by King Khaled Eye Specialist Hospital:

Primary Outcome Measures:

Corneal re-epithelialization (= initial success)
Persistent corneal re-epithelialization (= lasting success)

Estimated Enrollment:	180
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238862

Locations

Saudi Arabia
King Khaled Eye Specialist Hospital
Riyadh, Saudi Arabia, 11462

Sponsors and Collaborators

King Khaled Eye Specialist Hospital

Investigators

Principal Investigator:

Michael D Wagoner, MD

King Khaled Eye Specialist Hospital

More Information

No publications provided

Study ID Numbers:	RP0511-P
Study First Received:	October 12, 2005
Last Updated:	March 5, 2007
ClinicalTrials.gov Identifier:	NCT00238862 History of Changes
Health Authority:	Saudi Arabia: Ministry of Health; KKESH: IRB Monitor

Keywords provided by King Khaled Eye Specialist Hospital:

Diabetes
Corneal transplant
Neurotrophic keratitis
Post-bacterial keratitis
Metaherpetic keratitis

Study placed in the following topic categories:

Diabetes Mellitus
Keratitis

ClinicalTrials.gov processed this record on September 11, 2009