Healing of Persistent Epithelial Defects

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02395952

Enrollment

Registered

2015-03-24

Start date

2015-03-31

Completion date

2018-02-28

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cornea

Keywords

cornea, epithelial defect, amniotic membrane

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.

Interventions

DRUGcarboxymethylcellulose sodium

frequent topical lubrication with artificial tears

DEVICEAcuvue Oasys Bandage Contact Lens

DEVICEAmbiodisk

DEVICEProkera

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Abscence of persistent epithelial defect	22 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026