Healing of Persistent Epithelial Defects

February 2, 2019 updated by: Seth M Pantanelli, Milton S. Hershey Medical Center

Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

3.1 Inclusion Criteria

  • Adults aged 18 and older (inclusive) at the time of study enrollment
  • Recent history of retina surgery
  • Presence of persistent epithelial defect 7 days or later after surgery
  • English speaking

3.2 Exclusion Criteria

  • Non-English speaking patients
  • Inability to incapacity to provide consent for the study
  • History of corneal epithelial or limbal stem cell disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lubrication
Drug: carboxymethylcellulose sodium
frequent topical lubrication with artificial tears
Active Comparator: Bandage Contact Lens
Acuvue Oasys Contact Lens
Device: Acuvue Oasys Bandage Contact Lens
Active Comparator: Prokera
Wet amniotic membrane mounted on plastic retaining ring
Device: Prokera
Active Comparator: Ambiodisk
Freeze dried amniotic membrane
Device: Ambiodisk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abscence of persistent epithelial defect
Time Frame: 22 days
22 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of epithelial healing in mm2/day
Time Frame: 22 days
22 days
Infection
Time Frame: 22 days
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 2, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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