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

NCT ID: NCT03000556

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Epithelium Exfoliation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experience

Group Type EXPERIMENTAL

0.3% Sodium Hyaluronate Eye Drop

Intervention Type DRUG

The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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0.3% Sodium Hyaluronate Eye Drop

The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fang Duan

OTHER

Sponsor Role lead

Responsible Party

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Fang Duan

clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhongshan ophthalmic center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Duan, doctor

Role: CONTACT

Phone: 8613710790313

Email: [email protected]

Facility Contacts

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Fang Duan

Role: primary

Zhaohui Yuan

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33369934 (View on PubMed)

Other Identifiers

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AL-2016-DF

Identifier Type: -

Identifier Source: org_study_id