The Debridement To Treat The Traumatic Corneal Abrasion

NCT ID: NCT05534217

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-01-01

Brief Summary

Patients who signed informed consent to participate in the study will receive corneal epithelial deplasia. The patient was instructed to follow up closely in the following year, and the recurrence of the patient was collected through wechat follow-up.

Detailed Description

Traumatic corneal abrasion (TCA) refers to the injury or defect of the corneal epithelium caused by a foreign object (such as a nail, a tree branch, etc.), which is characterized by severe eye pain accompanied by red eyes, blepharospasm, photophobia, tearing, and a distinct foreign body sensation. TCA is one of the common eye injuries and ophthalmic emergencies, accounting for about 5%-10% in ophthalmic emergencies. Methods: The investigators conducted a clinical trial in adult patients with corneal trauma at the Zhongshan Ophthalmology Center of Sun Yat-sen University. Patients who signed informed consent to participate in the study were provided with corneal epithelial debridement. Patients were instructed to follow closely for the following year, and a pain log of the patient was collected at the last ophthalmology clinic visit.

Conditions

Corneal Abrasion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

debridement+traditional treatment

The experimental group receives debridement of the abrasion wound before receiving traditional treatment including evofloxacin eye drops + befushu QID \* for 14 days, four times a day, and the corneal contact lens was worn for 2 weeks.

Group Type: EXPERIMENTAL

corneal debridement of corneal abrasion

Intervention Type: BIOLOGICAL

Surgical debridement for traumatic corneal epithelial abrasions

traditional treatment

The traditional group receives evofloxacin eye drops + befushu QID \* for 14 days, four times a day, and the corneal contact lens was worn for 2 weeks.

Group Type: ACTIVE_COMPARATOR

corneal debridement of corneal abrasion

Intervention Type: BIOLOGICAL

Surgical debridement for traumatic corneal epithelial abrasions

Interventions

corneal debridement of corneal abrasion

Surgical debridement for traumatic corneal epithelial abrasions

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The affected eye is traumatic corneal epithelial abrasion, and the specific criteria are as follows: A: Damage caused by one of the three high risk causes of recurrent corneal epithelial exfoliation defined as fingernails, paper, or plant leaves; B: Monocular disease; C: Eye pain, tears, photophobia and foreign body sensation when injured; D: Local defect of corneal epithelium was found at the time of injury, and fluorescein sodium staining was positive; E: The time from injury to first diagnosis is less than 24 hours.

2. Be between the ages of 18 and 60.

3. Patients volunteered to participate in the study and signed the informed consent, showing good compliance.

Exclusion Criteria

1. Corneal epithelial defect complicated with infection.

2. Patients with other ocular surface diseases (such as eyelid insufficiency, eyelid gland dysfunction, Sjogren's syndrome, bullae keratopathy, corneal dystrophy, drug induced corneal toxicity, etc.).

3. Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery;

4. Long-term contact lens wearers.

5. Pregnant or lactating women; Severe impairment of heart, liver and kidney function; One who is mentally abnormal; People with other inflammatory or autoimmune diseases. Corneal epithelial defect complicated with infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhaohui Yuan

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Zhaohui Yuan, Doctor's degree

Role: CONTACT

yuanzhaohui.@gzzoc.com

13570961208

Facility Contacts

Zhaohui Yuan, doctor

Role: primary

yuanzhaohui.@gzzoc.com

13570961208

Other Identifiers

2022KYPJ139

Identifier Type: -

Identifier Source: org_study_id