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

Condition(s) targeted: Corneal Diseases

Phase: N/A

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Fung-Rong Hu, MD, Principal Investigator, Affiliation: Department of Ophthalmology, National Taiwan Universtiy Hospital

Overall contact:
Wei-Li Chen, M.D PhD, Phone: 886-2-23123456, Ext: 65206, Email: chenweili@ntu.edu.tw

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

Study design: Case-Only, Prospective

Primary outcome: cellular morphology and density

Secondary outcome:

corneal basal/apical surface epithelia, stromal reactions and corneal endothelial conditions

visual acuity

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Wei-Li Chen, M.D PhD, Phone: 886-2-23123456, Ext: 65206, Email: chenweili@ntu.edu.tw

Wei-Li Chen, Taipei, Taiwan; Recruiting
Wei-Li Chen, MD, PhD, Email: cwlboston@yahoo.com.tw
Fung-Rong Hu, MD, Principal Investigator

Starting date: April 2007
Ending date: September 2010
Last updated: June 1, 2009