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

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National Taiwan University

Status

Completed

Conditions

Corneal Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT00491439
200702038R

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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