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
  Purpose

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
Corneal Diseases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: April 2007
Study Completion Date: September 2010
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491439

Locations
Taiwan
Wei-Li Chen
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fung-Rong Hu, MD Department of Ophthalmology, National Taiwan Universtiy Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital, Wei-Li Chen/Associate Professor
ClinicalTrials.gov Identifier: NCT00491439     History of Changes
Other Study ID Numbers: 200702038R
Study First Received: June 23, 2007
Last Updated: April 1, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
in vivo confocal microscopy
vitrectomy
corneal transplantation
Epi-LASIK
wound healing

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014