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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00491439

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

cellular morphology and density [before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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