Healing of Persistent Epithelial Defects

Penn State Health

Status: Withdrawn

Conditions: Cornea

Treatments: Drug: carboxymethylcellulose sodium; Device: Ambiodisk; Device: Acuvue Oasys Bandage Contact Lens; Device: Prokera

Study type: Interventional

Funder types: Other

Identifiers

NCT02395952

STUDY00001309

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

Lubrication

Active Comparator group

Treatment:

Drug: carboxymethylcellulose sodium

Bandage Contact Lens

Active Comparator group

Description:

Acuvue Oasys Contact Lens

Treatment:

Device: Acuvue Oasys Bandage Contact Lens

Prokera

Active Comparator group

Description:

Wet amniotic membrane mounted on plastic retaining ring

Treatment:

Device: Prokera

Ambiodisk

Active Comparator group

Description:

Freeze dried amniotic membrane

Treatment:

Device: Ambiodisk