February 8, 2023
1:30 pm / 3:00 pm
TITLE: The novel rabbit model of corneal reinnervation surgery in denervated eye
INVESTIGATORS:
Patcharaporn Chandraparnik (1,2)
Andrea Kossler (1)
Cigdem Yasar (1)
David Myung (1)
- Ophthalmology Department, Byers Eye Institute, Stanford University, California, USA
- Ophthalmology Department, Phramongkutklao Hospital/College of Medicine, Bangkok, Thailand
DATE: Wednesday, 8 February 2023
TIME: 1:30–3:00 PM
LOCATION: Conference Room X399, Medical School Office Building, 1265 Welch Road, Stanford, CA
WEBPAGE: https://dbds.stanford.edu/data-studio/
ABSTRACT
The Data Studio Workshop brings together a biomedical investigator with a group of experts for an in-depth session to solicit advice about statistical and study design issues that arise while planning or conducting a research project. This week, the investigator(s) will discuss the following project with the group.
INTRODUCTION
Neurotrophic keratopathy (NK) is a rare and underdiagnosed degenerative disease of the cornea that is caused by damage to the ophthalmic branch of the trigeminal nerve. Epithelial breakdown, corneal ulceration, corneal melting (thinning), perforation, and loss of vision may occur over time. Currently, corneal reinnervation surgery is the only method to regrow the sensory nerve in the cornea to treat NK.
STUDY DESIGN
We wish to create the rabbit model of corneal reinnervation. Corneal reinnervation rabbit models will be utilized in further studies to evaluate the efficacy of each vehicle that delivers growth factors to accelerate nerve regeneration after the surgery. We plan to conduct the study in 2 phases with all rabbits undergoing both phases.
Phase 1: Denervation surgery by using radio-frequency thermocoagulation to create lesion at trigeminal ganglion. Corneal wound will be created on the same side of trigeminal ganglion lesion.
Phase 2: Reinnervation surgery by using infraorbital nerve graft connect to limbus of cornea. Corneal wound will be created on the same side.
HYPOTHESIS & AIM
Our aim is to assess the rate of corneal abrasion wound closure in reinnervated eye in rabbit. We hypothesize that the rate of corneal abrasion wound closure will be increased in reinnervated eye compared to denervated eye.
DATASET
We will collect the following data from each rabbit: size of corneal wound, blink rate, tear meniscus, and survival of rabbit. The primary outcome will be the rate of corneal wound healing in each group. The secondary outcomes are corneal sensation, blink rate, blink reflex, tear meniscus, and survival of rabbit.
STATISTICAL ISSUES
- Sample size calculation for number of rabbits needed to show statistical significance in denervation group?
- How many treatment groups (i.e., number of vehicles that deliver growth factors to accelerate nerve regeneration after the surgery) can we accommodate?
- Should we have a single control group or one for each treatment group?
- Given the general constraint of minimizing the number of study animals, how should we deal with missing data (e.g., death of the rabbit, failure to collect data from a rabbit, etc.)?
- What is the appropriate design for this experimental study?
- Do we need to control for multiple comparisons?
- Should we use parametric or nonparametric methods for the hypothesis tests in this study?
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