TCTR20130627002
Recruiting
Phase 2
A comparison of the efficacy of botulinum toxin type A induced protective ptosis and temporary tarsorrhaphy in persistent corneal epithelial defect conditions. (Pilot study)
Ratchadapiseksompotch Research Fund0 sites11 target enrollmentJune 27, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Is the efficacy of botulinum toxin type A induced protective ptosis better than temporary tarsorrhaphy in persistent corneal epithelial defect?
- Sponsor
- Ratchadapiseksompotch Research Fund
- Enrollment
- 11
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •This research is a pilot study. The sample size is 15 cases for each controlled and intervention group. The small number of sample size is due to limited PED cases. A total of 30 consecutive patients (1 affected eye for each patient) will be recruited from general eye clinic at the department of ophthalmology, King Chulalongkorn Memorial Hospital. This trial will be conducted between October 2012 to October 2014, The inclusion criteria is as followings:
- •Inclusion criteria :
- •1\.Age \> 18 year
- •2\.Persistent corneal epithelial defect patient (1 affected eye for each patient)
Exclusion Criteria
- •Exclusion criteria :
- •1\.Underlying disease that impairs corneal epithelial wound healing such as uncontrolled DM
- •2\.Contraindications to Botulinum toxin type A (BOTOX) or temporary tarsorrhaphy
- •3\.Uncontrolled corneal infection
- •4\.Complications from PED : perforation , progressive thinning , active infection , not heal in 3 months
Outcomes
Primary Outcomes
Not specified
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