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

April 1, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Wei-Li Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cellular morphology and density
Time Frame: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months
before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
visual acuity
Time Frame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Fung-Rong Hu, MD, Department of Ophthalmology, National Taiwan Universtiy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion

December 7, 2022

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 23, 2007

First Submitted That Met QC Criteria

June 23, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

April 1, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200702038R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe