Healing of Persistent Epithelial Defects

NCT02395952 — Not applicable, Withdrawn, Milton S. Hershey Medical Center

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

Registry	NCT02395952
Status	Withdrawn - No patients recruited
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Sponsor	Milton S. Hershey Medical Center (Other)
Conditions	Cornea
Interventions	carboxymethylcellulose sodium, Acuvue Oasys Bandage Contact Lens, Ambiodisk, Prokera (Drug, device)
Dates	start 2015-03-01, primary completion 2018-02-01, completion 2018-02-01, first posted 2015-03-24, last updated 2019-02-05
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lubrication	Active comparator	Drug: carboxymethylcellulose sodium
Bandage Contact Lens	Active comparator	Device: Acuvue Oasys Bandage Contact Lens	Acuvue Oasys Contact Lens
Prokera	Active comparator	Device: Prokera	Wet amniotic membrane mounted on plastic retaining ring
Ambiodisk	Active comparator	Device: Ambiodisk	Freeze dried amniotic membrane

carboxymethylcellulose sodium (Drug): frequent topical lubrication with artificial tears
Acuvue Oasys Bandage Contact Lens (Device)
Ambiodisk (Device)
Prokera (Device)

+Outcome measures

Primary outcomes

Abscence of persistent epithelial defect [22 days]

Secondary outcomes

Rate of epithelial healing in mm2/day [22 days]
Infection [22 days]

+Eligibility

Sex: All, ages: 18 Years to any, accepts 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

+Locations (1)

Facility	City	Country	Status
Penn State Hershey Eye Center	Hershey, Pennsylvania	United States