Using in Vivo Confocal Microscope to Evaluate the Corneal... | NCT00491439

Studies
Using in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries

NCT00491439

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Apr 3, 2012Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Corneal Diseases

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Sep 2010Actual

First Submitted Date

Jun 23, 2007

First Submission Date that Met QC Criteria

Jun 23, 2007

First Posted Date

Jun 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Hospital, Wei-Li Chen/Associate Professor, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Although epi-keratome laser-assisted in situ keratomileusis (Epi-LASIK), penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy are surgeries commonly performed, the time-sequential, in vivo microscopic wound healing process is not fully understood. The purpose of this study is to study the healing of corneal wounds after Epi-LASIK, penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement for diabetic retinopathy by in vivo confocal microscopy, an easily performed and non-invasive procedure. We plan to enroll 40 eyes of 40 patients in each of these three surgeries. In Epi-LASIK, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and 1, 3, and 7 days after surgery. The eyes are examined weekly in the first month and at 3 and 6 months. For penetrating keratoplasty and pars plana vitrectomy with corneal epithelial debridement, slit-lamp biomicroscopy, in vivo confocal microscopy, and visual acuity are recorded before and weekly in the first month after surgeries and at 3 and 6 months. Selected images of the corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions by in vivo confocal microscopy are evaluated qualitatively for the cellular morphology and density.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Corneal wounds after Epi-LASIK		Corneal wounds after Epi-LASIK
penetrating keratoplasty		Corneal wound after penetrating keratoplasty
corneal epithelial debridement		Corneal wound after pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cellular morphology and density		before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions		before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
visual acuity		before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients receiving various ocular surgeries
no previous ocular surgery
tear break up time longer than 10 seconds
Shirmer test II larger than 5 mm
no presurgical corneal disease confirmed by slit lamp and in vivo confocal
no limbus defect
proliferative retinopathy underwent vitrectomy combining corneal epithelial scrating

Exclusion Criteria:

can not complete follow up
ineligible for ocular surgery
eyelid closure incomplete
glaucoma
corneal defect or oculoneuropathy not caused by diabetes
severe dry eye disease
limbus defect
pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving Epi-LASIK, penetrating keratoplasty and pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fung-Rong Hu, MD	Department of Ophthalmology, National Taiwan Universtiy Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wei-Li Chen		Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21357404	Derived	Chen WL, Shen EP, Hsieh YT, Yeh PT, Wang TJ, Hu FR. Comparison of in vivo confocal microscopic findings between epi-LASIK procedures with different management of the epithelial flaps. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3640-7. doi: 10.1167/iovs.10-6390.