NCT00491439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 3, 2012

Status Verified

November 1, 2010

First QC Date

June 23, 2007

Last Update Submit

April 1, 2012

Conditions

Corneal Diseases

Keywords

in vivo confocal microscopyvitrectomycorneal transplantationEpi-LASIKwound healing

Outcome Measures

Primary Outcomes (1)

  • cellular morphology and density

    before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months

Secondary Outcomes (2)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei-Li Chen

Taipei, Taiwan

Location

Related Publications (1)

  • Chen WL, Shen EP, Hsieh YT, Yeh PT, Wang TJ, Hu FR. Comparison of in vivo confocal microscopic findings between epi-LASIK procedures with different management of the epithelial flaps. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3640-7. doi: 10.1167/iovs.10-6390.

    PMID: 21357404DERIVED

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Fung-Rong Hu, MD

    Department of Ophthalmology, National Taiwan Universtiy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wei-Li Chen/Associate Professor

Study Record Dates

First Submitted

June 23, 2007

First Posted

June 26, 2007

Study Start

April 1, 2007

Study Completion

September 1, 2010

Last Updated

April 3, 2012

Record last verified: 2010-11

Locations

TW(1)