Clinical trial NCT03000556: 0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation
Official title: 0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Corneal Epithelium Exfoliation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.

0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.


Eligibility criteria: Inclusion Criteria:

* Definitive diagnosis of primary corneal epithelial abrasion;
* Monocular onset;
* Corneal epithelium was defected and fluorescein sodium staining was positive.

Exclusion Criteria:

* Corneal epithelial defect complicated with infection
* Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)
* Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases

Primary outcomes:
measure: the incidence of recurrent corneal epithelium exfoliation
timeFrame: 6 month
Secondary outcomes:
measure: the incidence of recurrent corneal epithelium exfoliation
timeFrame: 1 year
measure: corneal fluorescein staining score
timeFrame: 1 year
measure: Corneal edema grading
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan ophthalmic center
state: Guangdong
Study officials:
References:
citation: Wei M, Zou Y, Duan F, Ding X, Zhuang J, Deng J, Yuan Z. Efficacy of Long-term Use of 0.3% Sodium Hyaluronate Eye Drops for Traumatic Corneal Abrasion: A Randomized Controlled, Pilot Trial. Cornea. 2021 Oct 1;40(10):1248-1252. doi: 10.1097/ICO.0000000000002625.