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Healing of Persistent Epithelial Defects

Primary Purpose

Cornea

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
carboxymethylcellulose sodium
Acuvue Oasys Bandage Contact Lens
Ambiodisk
Prokera
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cornea focused on measuring cornea, epithelial defect, amniotic membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Hershey Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lubrication

Bandage Contact Lens

Prokera

Ambiodisk

Arm Description

Acuvue Oasys Contact Lens

Wet amniotic membrane mounted on plastic retaining ring

Freeze dried amniotic membrane

Outcomes

Primary Outcome Measures

Abscence of persistent epithelial defect

Secondary Outcome Measures

Rate of epithelial healing in mm2/day
Infection

Full Information

First Posted
March 10, 2015
Last Updated
February 2, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02395952
Brief Title
Healing of Persistent Epithelial Defects
Official Title
Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No patients recruited
Study Start Date
March 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea
Keywords
cornea, epithelial defect, amniotic membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubrication
Arm Type
Active Comparator
Arm Title
Bandage Contact Lens
Arm Type
Active Comparator
Arm Description
Acuvue Oasys Contact Lens
Arm Title
Prokera
Arm Type
Active Comparator
Arm Description
Wet amniotic membrane mounted on plastic retaining ring
Arm Title
Ambiodisk
Arm Type
Active Comparator
Arm Description
Freeze dried amniotic membrane
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose sodium
Intervention Description
frequent topical lubrication with artificial tears
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys Bandage Contact Lens
Intervention Type
Device
Intervention Name(s)
Ambiodisk
Intervention Type
Device
Intervention Name(s)
Prokera
Primary Outcome Measure Information:
Title
Abscence of persistent epithelial defect
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Rate of epithelial healing in mm2/day
Time Frame
22 days
Title
Infection
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Hershey Eye Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Healing of Persistent Epithelial Defects

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