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NCT02395952 Clinical Trial

Healing of Persistent Epithelial Defects

Cornea Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02395952
Other study ID # STUDY00001309
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date February 2018

Study information
Verified date February 2019
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• carboxymethylcellulose sodium
frequent topical lubrication with artificial tears
Device:
• Acuvue Oasys Bandage Contact Lens

• Ambiodisk

• Prokera

Locations
Country Name City State
United States Penn State Hershey Eye Center Hershey Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Abscence of persistent epithelial defect 22 days
Secondary Rate of epithelial healing in mm2/day 22 days
Secondary Infection 22 days
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