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

NCT ID: NCT00491439

Last Updated: 2012-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Corneal Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Corneal wounds after Epi-LASIK

Corneal wounds after Epi-LASIK

No interventions assigned to this group

penetrating keratoplasty

Corneal wound after penetrating keratoplasty

No interventions assigned to this group

corneal epithelial debridement

Corneal wound after pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Wei-Li Chen/Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fung-Rong Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, National Taiwan Universtiy Hospital

Locations

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Wei-Li Chen

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 21357404 (View on PubMed)

Other Identifiers

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200702038R

Identifier Type: -

Identifier Source: org_study_id

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