The Debridement To Treat The Traumatic Corneal Abrasion

NCT05534217 | Unknown

• 1 other identifier: 2022KYPJ139
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Abrasion

Outcome Measures

Primary Outcomes (1)

• wound recurrence

  Wound recurrence during 12 months after treatment.

  month 12 after treatment

Secondary Outcomes (3)

• Incidence of wound infection

  week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

• The grading of pain for eyes

  week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

• Corneal scar

  week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

Study Arms (2)

debridement+traditional treatment

EXPERIMENTAL

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.

Biological: corneal debridement of corneal abrasion

traditional treatment

ACTIVE COMPARATOR

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.

Biological: corneal debridement of corneal abrasion

Interventions

corneal debridement of corneal abrasion BIOLOGICAL

Surgical debridement for traumatic corneal epithelial abrasions

debridement+traditional treatment; traditional treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Be between the ages of 18 and 60.
• Patients volunteered to participate in the study and signed the informed consent, showing good compliance.

You may not qualify if:

• Corneal epithelial defect complicated with infection.
• 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.).
• Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery;
• Long-term contact lens wearers.
• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhaohui Yuan

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Central Study Contacts

Zhaohui Yuan, Doctor's degree

CONTACT

13570961208; yuanzhaohui.@gzzoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants didn't know where they were grouped,and the experimenters did not know about the trial either.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients diagnosed with traumatic corneal epithelial abrasions are treated by complete debridement of the corneal epithelium

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: September 9, 2022
• Study Start: December 31, 2022
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)