Clinical trial NCT00491439: Using in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries
Official title: Phase 1 Study of in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Diseases
Keywords: in vivo confocal microscopy
vitrectomy
corneal transplantation
Epi-LASIK
wound healing
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving Epi-LASIK, penetrating keratoplasty and pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy

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.

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 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

Primary outcomes:
measure: cellular morphology and density
timeFrame: before surgery and 1, 3, and 7 days after surgeryfirst month and at 3 and 6 months
Secondary outcomes:
measure: corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions
timeFrame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
measure: visual acuity
timeFrame: before and 1, 3, and 7 days after surgery, first month and at 3 and 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wei-Li Chen
Study officials:
affiliation: Department of Ophthalmology, National Taiwan Universtiy Hospital
name: Fung-Rong Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.