NCT02395952

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

March 10, 2015

Last Update Submit

February 2, 2019

Conditions

Cornea

Keywords

corneaepithelial defectamniotic membrane

Outcome Measures

Primary Outcomes (1)

  • Abscence of persistent epithelial defect

    22 days

Secondary Outcomes (2)

  • Rate of epithelial healing in mm2/day

    22 days

  • Infection

    22 days

Study Arms (4)

Lubrication

ACTIVE COMPARATOR
Drug: carboxymethylcellulose sodium

Bandage Contact Lens

ACTIVE COMPARATOR

Acuvue Oasys Contact Lens

Device: Acuvue Oasys Bandage Contact Lens

Prokera

ACTIVE COMPARATOR

Wet amniotic membrane mounted on plastic retaining ring

Device: Prokera

Ambiodisk

ACTIVE COMPARATOR

Freeze dried amniotic membrane

Device: Ambiodisk

Interventions

carboxymethylcellulose sodiumDRUG

frequent topical lubrication with artificial tears

Lubrication
Acuvue Oasys Bandage Contact LensDEVICE
Bandage Contact Lens
AmbiodiskDEVICE
Ambiodisk
ProkeraDEVICE
Prokera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking patients
  • Inability to incapacity to provide consent for the study
  • History of corneal epithelial or limbal stem cell disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

US(1)