A comparison of the efficacy of botulinum toxin type A induced protective ptosis and temporary tarsorrhaphy in persistent corneal epithelial defect conditions. (Pilot study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20130627002

Enrollment

Registered

2013-06-27

Start date

2013-06-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Is the efficacy of botulinum toxin type A induced protective ptosis better than temporary tarsorrhaphy in persistent corneal epithelial defect? persistent epithelial defect&#44

Interventions

2% xylocaine with adrenaline will be injected at lateral one&#45

third of upper and lower eyelid for local anesthesia. Continuous suture with 4&#45

0 nylon material will be performed to approximate upper and lower eyelid at the injected area. ,the ocular surface will be anesthetized by 0.5% tetracaine hydrochloride eye drops. The 5 units of botu

using a 30&#45

gauge needle mounted in a 1.0 ml syringe.

Experimental Procedure/Surgery,Experimental Procedure/Surgery

Temporary tarsorrhaphy,Botulinum toxin injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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: 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

Design outcomes

Primary

Measure	Time frame
duration of complete healing (days) 3 months after end of the intervention duration of complete healing (days)	—

Secondary

Measure	Time frame
size of healing area and cosmetic consideration 3 months after end of the intervention size of healing area and cosmetic consideration	—

Contacts

Public ContactSupalukana Tiemmeka

Chulalongkorn university

amm_khana@hotmail.com089-4501511

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026