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

Completed
Conditions
Corneal Diseases
Registration Number
NCT00491439
Lead Sponsor
National Taiwan University Hospital
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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
cellular morphology and densitybefore surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months
Secondary Outcome Measures
NameTimeMethod
corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditionsbefore and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
visual acuitybefore and 1, 3, and 7 days after surgery, first month and at 3 and 6 months

Trial Locations

Locations (1)

Wei-Li Chen

🇨🇳

Taipei, Taiwan

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