Healing of Persistent Epithelial Defects | NCT02395952

Studies
Healing of Persistent Epithelial Defects

NCT02395952

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

Feb 5, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cornea

Interventions

carboxymethylcellulose sodium
Acuvue Oasys Bandage Contact Lens
Ambiodisk
Prokera

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients recruited

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Mar 10, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2019

Last Update Posted Date

Feb 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seth M Pantanelli, Assistant Professor of Ophthalmology, Milton S. Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lubrication	Active Comparator		Drug: carboxymethylcellulose sodium
Bandage Contact Lens	Active Comparator	Acuvue Oasys Contact Lens	Device: Acuvue Oasys Bandage Contact Lens
Prokera	Active Comparator	Wet amniotic membrane mounted on plastic retaining ring	Device: Prokera
Ambiodisk	Active Comparator	Freeze dried amniotic membrane	Device: Ambiodisk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carboxymethylcellulose sodium	Drug	frequent topical lubrication with artificial tears	Lubrication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abscence of persistent epithelial defect		22 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Hershey Eye Center		Hershey	Pennsylvania	17033	United States

ID	Term
D003316	Corneal Diseases

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D002266	Carboxymethylcellulose Sodium

Ancestor Terms

ID	Term
D008747	Methylcellulose
D002482	Cellulose
D005936	Glucans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided