Ptosis, Eyelid Clinical Trial
Official title:
Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
Verified date | July 2012 |
Source | Aurolab |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis
Status | Completed |
Enrollment | 16 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Congenital Ptosis - Severe Ptosis (MRD<0) - Poor levator function (<4mm by Berke's method) - Myogenic Ptosis (Myasthenia gravis) - Chronic progressive external ophthalmoplegia - Neurogenic Ptosis (Third cranial palsy) - Blepharospasm - Ptosis caused by trauma Exclusion Criteria: - Acquired Ptosis - Horners syndrome - Blepharochalasis/Dermatochalasis - Mechanical Ptosis - Mild or Moderate Ptosis (MRD 1>1) - Good or fair levator function (>4 mm by Berke's method) - Previous Ptosis surgery - Ptosis associated syndromes/Other anomalies including - Marcus Gunn jaw winking syndrome - Blepharophimosis syndrome - Dry eye syndromes - Corneal anesthesia - Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia - Nystagmus where adequate measurements could not be done - Uncorrected vertical squint of any sort |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Aravind Eye Hospital | Madurai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Aurolab |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ptosis Correction | 15th day, 90th day postoperatively | No | |
Secondary | Adverse Events | 15th day, 90th day postoperatively | Yes |
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