Status:
UNKNOWN
Low Dose Doxycycline in the Treatment of Corneal Burn
Lead Sponsor:
Sun Yat-sen University
Conditions:
Eye Burns
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.
Detailed Description
Severe Ocular Burn often leads to the Ocular surface failure, corneal vascularization dissolved hole or corneal opacity.Because the conventional treatment effect is not ideal, blindness rate is extrem...
Eligibility Criteria
Inclusion
- age from 18-70 years old, not limited to sex
- 2\. ocular burn (including chemical injury, thermal burns)
- 3\. studies of eye with Dua grade (2001) III, within 14 days after burns
- 4\. about the eye burns
- become the research with only one eye
- conform to the standards of subjects for the eyes
- Choose poor eyesight as in the study
- If the vision is the same on both sides, the choice classification is higher as the research of eye
- If the binocular vision and graded at the same time, according to a study in can be determined in consultation with the patient's eye
- signed informed consent form
Exclusion
- \- 1. Only one eye function
- The exclusion criteria of the eye
- A) corneal thinning depth ≥ 1/2CT, corneal perforation or perforation tendency
- B, Dua classification I、II、IV、V、VI
- C) after injury had received eye operation (such as amniotic membrane transplantation or covering)
- D) Poor control of intraocular pressure after anti-glaucoma drug treatment (IOP ≥ 25mmHg)
- E) past other corneal diseases
- F) past ocular history of radiation therapy or eye operation history
- G) eyelid defect, incomplete eyelid closure, entropion, trichiasis
- 3\. Any side formulated after secondary infection
- 4\. Other rule out criteria
- A) Tetracycline class history of drug allergy
- B) poor control of blood pressure (defined as after treatment with antihypertensive drugs, blood pressure is 150/95mmHg or higher)
- C) serious heart, hepatic, renal insufficiency (or myocardial infarction, arrhythmia, myocardial ischemia and cardiac insufficiency, ALT, AST, upper limit of normal or higher by 2.5 times, creatinine upper limit of normal or higher by 1.5 times)
- D) during pregnancy or lactation women (defined as pregnancy urine pregnancy test results in this test)
- E) child-bearing age subjects (male and female) is suitable precautions during the entire study
- F) into the group participated in other clinical subjects before 3 months
- G) people with TB
- H) nerve with mental illness
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01886560
Start Date
September 1 2013
End Date
September 1 2014
Last Update
August 9 2013
Active Locations (1)
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1
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060