0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation

0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Epithelium Exfoliation
• Intervention / Treatment: Drug: 0.3% Sodium Hyaluronate Eye Drop

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Fang Duan; Phone Number: 86-20-87331537; Email: duanfangg@126.com
      • Contact: Zhaohui Yuan; Phone Number: 86-20-87331537; Email: zhaohui1208@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: experience	Drug: 0.3% Sodium Hyaluronate Eye Drop; The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of recurrent corneal epithelium exfoliation	Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of recurrent corneal epithelium exfoliation	Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.	1 year
corneal fluorescein staining score	Grading of corneal epithelial fluorescein sodium staining under slit lamp. The average cornea was divided into four quadrants and scored separately, adding all the scores to get the final score. Scoring criteria: 0 point: no staining; 1 point: punctate staining less than 30 dots; 2 points: punctate staining more than 30 dots, more than the point of the color but not scattered; 3 points: severe dispersion staining but no plaque staining; 4 points: plaque staining. Maximum score of 16 points per eye.	1 year
Corneal edema grading	Grading of corneal edema under slit lamp. 0 point: C、corneal transparency without edema; 1 point: corneal haze edema, corneal endothelium smooth, iris texture is clearly visible; 2 points: corneal surface roughness, iris texture fuzzy; 3 points: corneal endothelial surface cracking, iris texture as is not clear; 4 points: white corneal edema, intraocular structure as unclear.	1 year

Collaborators and Investigators

• Sponsor: Fang Duan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: AL-2016-DF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES