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

Study Overview
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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.

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

Conditions
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Corneal Diseases

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Corneal wounds after Epi-LASIK<br>Corneal wounds after Epi-LASIK | |
| penetrating keratoplasty<br>Corneal wound after penetrating keratoplasty | |
| corneal epithelial debridement<br>Corneal wound after pars plana vitrectioy with corneal epithelial debridement for diabetic retinopathy | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vivo confocal microscopy, vitrectomy, corneal transplantation, Epi-LASIK, wound healing