NCT00238862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

First QC Date

October 12, 2005

Last Update Submit

November 21, 2021

Conditions

Corneal Epithelial Defect

Keywords

DiabetesCorneal transplantNeurotrophic keratitisPost-bacterial keratitisMetaherpetic keratitis

Outcome Measures

Primary Outcomes (2)

  • Corneal re-epithelialization (= initial success)

  • Persistent corneal re-epithelialization (= lasting success)

Interventions

Amniotic membrane transplantationPROCEDURE
Autologous serum/BSS 20%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael D Wagoner, MD

    King Khaled Eye Specialist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

October 1, 2005

Study Completion

September 1, 2006

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

SA(1)