Title: Effect of Oculenis Ophthalmic Lubricant vs No Lubricant on Healing Times following Cotton Tipped Applicator Debridement in Canine Patients with Naturally Occurring Spontaneous Chronic Corneal Epithelial Defect (SCCED)
Investigator:
Kathern Myrna DVM, MS, DACVO
Alex Zilberfarb, DVM
If interested, please have your primary veterinarian request additional information from our Clinical Trials office at 706-296-7818 or through the University of Georgia (UGA) Ophthalmology Service at [email protected] (Attn: Dr.Zilberfarb)
Study description:
Spontaneous chronic corneal epithelial defects (SCCEDs) are a naturally occurring disease process in which the cornea spontaneously ulcerates. However, due to a fundamental difference in the cornea’s ability to heal, these ulcers linger and require mechanical procedures to encourage healing. Multiple adjuvant drug and mechanical procedures have been advocated to improve healing rates, but these studies rely on scheduled rechecks to assess healing. As these studies rarely show significant differences in healing time, it is vital that a more accurate assessment of healing be investigated. Our recent work with daily fluorescein monitoring has allowed us to assess to the day when healing occurs. This study proposes to utilize at-home photography to assess time to healing for dogs with SCCED with and without the addition of ophthalmic lubrication drops. We hypothesize that use of daily lubricant will shorten healing times for dogs with naturally occurring SCCED.
Inclusion criteria:
- Any dogs with a superficial, non-healing ulcer (not healed 7 days after diagnosis)
- No evidence of underlying ophthalmic disease (dry eye, uveitis, corneal endothelial degeneration, etc.)
- No debridement previously performed
- Dogs receiving topical antibiotics for ulcer management only
- Clients with smart phone and camera, comfortable with taking and sending pictures daily
Dogs with corneal defects will be screened for enrollment by physical and ophthalmic examination during which initial ulcer size and volume will be measured. Enrolled dogs will receive a cotton tipped debridement of the ulcer. All participants will receive antibiotic drops three times daily to prevent secondary infection, and 50% of dogs will be randomized to receive Oculenis ophthalmic lubricant or saline, to be given three times daily as well. Clients will be provided with fluorescein stain and required medication, and will be trained on how to appropriately administer at home. Each day clients will be required to take pictures after staining using a provided smartphone camera adapter (Quick Vue ®) with a cobalt blue filter (to highlight fluorescein uptake), and send to the ophthalmology service. Once the patient appears to be negative for fluorescein uptake via photographs, re-evaluation by an ophthalmologist will be performed within 24 hours to confirm complete ulcer epithelialization.
Study funds will pay for the initial exam fee and debridement, premixed fluorescein drops, and the QuikVue® camera adapter with cobalt filter. Study funds will also pay for a more advanced debridement if the ulcer is not healed by Day 14. Owners are responsible for costs of the recheck visit.
Duration of study:
The study is currently OPEN.
Potential benefits to veterinary medicine:
Spontaneous chronic corneal epithelial defects are a naturally occurring disease process in which the cornea spontaneously ulcerates. Cross-linked hyaluronic acid ophthalmic lubricant (Oculenis) is designed to speed healing times but has not been thoroughly evaluated. With the ability to stain daily, we hope to determine if a statistically significant difference can be assessed.
