Healing of Persistent Epithelial Defects

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02395952
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 4
• Actual Duration (Months): 35.1
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea	Drug: carboxymethylcellulose sodium; Device: Acuvue Oasys Bandage Contact Lens; Device: Ambiodisk; Device: Prokera	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lubrication	Drug: carboxymethylcellulose sodium; frequent topical lubrication with artificial tears
Active Comparator: Bandage Contact Lens Acuvue Oasys Contact Lens	Device: Acuvue Oasys Bandage Contact Lens
Active Comparator: Prokera Wet amniotic membrane mounted on plastic retaining ring	Device: Prokera
Active Comparator: Ambiodisk Freeze dried amniotic membrane	Device: Ambiodisk

Outcome Measures

Primary Outcome Measures

1. Abscence of persistent epithelial defect [22 days]

Secondary Outcome Measures

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

2. Infection [22 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Eye Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seth M Pantanelli, Assistant Professor of Ophthalmology, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02395952
• Other Study ID Numbers: STUDY00001309
• First Posted: Mar 24, 2015
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Seth M Pantanelli, Assistant Professor of Ophthalmology, Milton S. Hershey Medical Center: cornea; epithelial defect; amniotic membrane
• Additional relevant MeSH terms: Corneal Diseases; Carboxymethylcellulose Sodium

Study Results

No Results Posted as of Feb 5, 2019