Back to resultsEfficacy of Aurosling in Frontalis Sling Suspension Surgery
Primary Purpose
Ptosis, Eyelid
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Aurosling
Sponsored by
About this trial
This is an interventional treatment trial for Ptosis, Eyelid focused on measuring Blepharoptosis, Ophthalmoplegia, Blepharospasm
Eligibility Criteria
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
Sites / Locations
- Aravind Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Aurosling
Outcomes
Primary Outcome Measures
Ptosis Correction
Secondary Outcome Measures
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753831
Brief Title
Efficacy of Aurosling in Frontalis Sling Suspension Surgery
Official Title
Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurolab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis
Detailed Description
Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid
Keywords
Blepharoptosis, Ophthalmoplegia, Blepharospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Aurosling
Intervention Type
Procedure
Intervention Name(s)
Aurosling
Intervention Description
Silicon rod to be used in frontalis suspension surgery
Primary Outcome Measure Information:
Title
Ptosis Correction
Time Frame
15th day, 90th day postoperatively
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
15th day, 90th day postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usha Kim, DO, Dip NB
Organizational Affiliation
Aravind Eye Hospital, Madurai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Aurosling in Frontalis Sling Suspension Surgery
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