Healing of Persistent Epithelial Defects

Not Applicable

Withdrawn

• Conditions: Cornea
• Interventions: Device: Ambiodisk; Device: Acuvue Oasys Bandage Contact Lens; Device: Prokera; Drug: carboxymethylcellulose sodium

• Registration Number: NCT02395952
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambiodisk	Ambiodisk	Freeze dried amniotic membrane
Bandage Contact Lens	Acuvue Oasys Bandage Contact Lens	Acuvue Oasys Contact Lens
Prokera	Prokera	Wet amniotic membrane mounted on plastic retaining ring
Lubrication	carboxymethylcellulose sodium	-

Primary Outcome Measures

Name	Time	Method
Abscence of persistent epithelial defect	22 days

Secondary Outcome Measures

Name	Time	Method
Rate of epithelial healing in mm2/day	22 days
Infection	22 days

Trial Locations

Locations (1)

Penn State Hershey Eye Center; 🇺🇸 Hershey, Pennsylvania, United States