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Efficacy of Aurosling in Frontalis Sling Suspension Surgery

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ClinicalTrials.gov Identifier: NCT00753831
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Aurolab

Tracking Information
First Submitted Date  ICMJE September 16, 2008
First Posted Date  ICMJE September 17, 2008
Last Update Posted Date July 12, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2009)
Ptosis Correction [ Time Frame: 15th day, 90th day postoperatively ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2008)
Ptosis Correction [ Time Frame: 1st month, 3rd month, 6th month, 12th month postoperatively ]
Change History Complete list of historical versions of study NCT00753831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2009)
Adverse Events [ Time Frame: 15th day, 90th day postoperatively ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2008)
Adverse Events [ Time Frame: 1st month, 3rd month, 6th month, 12th month postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Aurosling in Frontalis Sling Suspension Surgery
Official Title  ICMJE Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ptosis, Eyelid
Intervention  ICMJE Procedure: Aurosling
Silicon rod to be used in frontalis suspension surgery
Study Arms  ICMJE Experimental: 1
Aurosling
Intervention: Procedure: Aurosling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2009)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2008)
40
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00753831
Other Study ID Numbers  ICMJE 2PR1220827
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aurolab
Study Sponsor  ICMJE Aurolab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Usha Kim, DO, Dip NB Aravind Eye Hospital, Madurai
PRS Account Aurolab
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP