Corneal AbrasionNCT05534217
The Debridement To Treat The Traumatic Corneal Abrasion
A study testing corneal debridement of corneal abrasion in people with Corneal Abrasion, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Abrasion
- What is being tested?
- corneal debridement of corneal abrasion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhaohui Yuan
Guangzhou, Guangdong, 510000
Zhaohui Yuan, doctor, 13570961208, yuanzhaohui.@gzzoc.com
About this study
Official title: A Prospective, Randomized, Double-blind, Controlled Clinical Study of Corneal Debridement to Treat the Traumatic Corneal Abrasion
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.
Read the 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
- Being tested
- corneal debridement of corneal abrasion
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal debridement of corneal abrasionBiological
Surgical debridement for traumatic corneal epithelial abrasions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: corneal debridement of corneal abrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound recurrence
Wound recurrence during 12 months after treatment.
Measured: month 12 after treatment
Secondary outcomes (3)
Incidence of wound infection
The incidence of wound infection during 12 months after treatment.
Measured: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
The grading of pain for eyes
The degree of pain is evaluated during 12months after wounded. VRS（verbal rating scale）is used to evaluate the grading of pain,which is a line to describe the degrees of the pain that patients suffer from the disease, and the high scores is a worse outcome.
The 5-point Verbal Rating Scale (VRS-5). （ ）Mild （ ）Discomforting （ ）Distressing （ ）Horrible （ ）Lxcruciaring
Measured: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
Corneal scar
It is evaluated by the doctor in follow-up during 12 months. The haze of the corneal scar，and the high scores is a worse outcome.
The degrees :
0-clear cornea 0.5 - trace/just perceptible
- - easily seen with slit-lamp
- - moderate haze
- - pronounced haze, iris details still visible
- - "scarring", iris detail obscured (visible with pen torch)
Measured: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start31 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AbrasionStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with traumatic corneal epithelial abrasions are treated by complete debridement of the corneal epithelium
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534217
- Sponsor's protocol ID
- 2022KYPJ139
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Controlled Clinical Study of Corneal Debridement to Treat the Traumatic Corneal Abrasion
- ClinicalTrials.gov ID
- NCT05534217
- Acronym / sponsor ID
- 2022KYPJ139
- Conditions
- Corneal Abrasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients diagnosed with traumatic corneal epithelial abrasions are treated by complete debridement of the corneal epithelium
| Arm | Type | Receives |
|---|---|---|
| debridement+traditional treatment | Experimental | Biological: corneal debridement of corneal abrasionThe 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. |
| traditional treatment | Active comparator | Biological: corneal debridement of corneal abrasionThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corneal debridement of corneal abrasionSurgical debridement for traumatic corneal epithelial abrasions | Biological | debridement+traditional treatment, traditional treatment |
Primary outcome
wound recurrence
Time frame: month 12 after treatment
Wound recurrence during 12 months after treatment.
3 secondary outcomes
Incidence of wound infection
Time frame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
The grading of pain for eyes
Time frame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
Corneal scar
Time frame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Corneal Abrasion
Not yet recruiting
IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
Corneal Abrasions
RecruitingPhase 3
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
Active, not recruitingPhase 1
Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa
Junctional Epidermolysis Bullosa, Epidermolysis Bullosa (EB)
RecruitingObservational study
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneal debridement of corneal abrasion in people with Corneal Abrasion, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Yuan, Doctor's degree (13570961208, yuanzhaohui.@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound recurrence (time frame: month 12 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.