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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT00491439

First received: June 23, 2007

Last updated: April 1, 2012

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2007

Last Updated Date

April 1, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

cellular morphology and density [ Time Frame: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00491439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions [ Time Frame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months ] [ Designated as safety issue: No ]
visual acuity [ Time Frame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 1 Study of in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Biospecimen

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Corneal Diseases

Intervention ^ICMJE

Study Group/Cohort (s)

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

Publications *

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. Print 2011 May.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

September 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00491439

Other Study ID Numbers ^ICMJE

200702038R

Has Data Monitoring Committee

Responsible Party

National Taiwan University Hospital

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Fung-Rong Hu, MD

Department of Ophthalmology, National Taiwan Universtiy Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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