The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Overview
- Phase
- Not Applicable
- Intervention
- Naltrexone Hydrochloride
- Conditions
- Cornea Ulcer
- Sponsor
- Minia University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- healing of ulcer
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.
Detailed Description
Corneal epithelial defects generally heal within 2 days without complications, in some patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for spontaneous healing Resistant corneal ulcers may appear as epithelial defects associated to Bowman's layer disruption with associated damage and partial variable loss of superficial corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with conventional treatment . Noninfectious corneal ulcers have a similar clinical presentation like that of infectious ulcers but with no known infectious cause . Resistant corneal ulcer can lead to serious complications such as infection, inflammation, corneal scarring, opacification, corneal thinning, and perforation . In our study NTX accelerated healing of resistant corneal ulcers that was refractory to conventional treatment with lubricant eye drops and was safe with no complications reported in all treated eyes.
Investigators
Ahemd Abdelghany
Associate professor
Minia University
Eligibility Criteria
Inclusion Criteria
- •refractory non infective corneal ulcer
Exclusion Criteria
- •infection
Arms & Interventions
Naltrexone group
25 eyes with refractory non infective corneal ulcer were subjected to daily insertion of a NTX film in the lower conjunctival fornix for 2 weeks
Intervention: Naltrexone Hydrochloride
Control
25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops
Intervention: Carboxy methyl cellulose
Outcomes
Primary Outcomes
healing of ulcer
Time Frame: 2 weeks
healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain