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Efficacy of Aurosling in Frontalis Sling Suspension Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753831
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : July 12, 2012
Information provided by (Responsible Party):

Brief Summary:
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis

Condition or disease Intervention/treatment Phase
Ptosis, Eyelid Procedure: Aurosling Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Procedure: Aurosling
Silicon rod to be used in frontalis suspension surgery

Primary Outcome Measures :
  1. Ptosis Correction [ Time Frame: 15th day, 90th day postoperatively ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 15th day, 90th day postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753831

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Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Sponsors and Collaborators
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Principal Investigator: Usha Kim, DO, Dip NB Aravind Eye Hospital, Madurai

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Responsible Party: Aurolab Identifier: NCT00753831     History of Changes
Other Study ID Numbers: 2PR1220827
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by Aurolab:
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases