A comparison of the efficacy of botulinum toxin type A induced protective ptosis and temporary tarsorrhaphy in persistent corneal epithelial defect conditions. (Pilot study)
- Conditions
- Is the efficacy of botulinum toxin type A induced protective ptosis better than temporary tarsorrhaphy in persistent corneal epithelial defect?persistent epithelial defect,PED,botulinum toxin,tarsorrhaphy,corneal epithelial defect
- Registration Number
- TCTR20130627002
- Lead Sponsor
- Ratchadapiseksompotch Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 11
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 :
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method duration of complete healing (days) 3 months after end of the intervention duration of complete healing (days)
- Secondary Outcome Measures
Name Time Method size of healing area and cosmetic consideration 3 months after end of the intervention size of healing area and cosmetic consideration