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Efficacy of Aurosling in Frontalis Sling Suspension Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT00753831
First received: September 16, 2008
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Ptosis, Eyelid
 Procedure: Aurosling
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Ptosis Correction [ Time Frame: 15th day, 90th day postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 15th day, 90th day postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aurosling
 Procedure: Aurosling
Silicon rod to be used in frontalis suspension surgery
Other Name: Aurosling

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753831

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

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT00753831     History of Changes
Other Study ID Numbers: 2PR1220827
Study First Received: September 16, 2008
Last Updated: July 11, 2012
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Blepharoptosis
Ophthalmoplegia
Blepharospasm

Additional relevant MeSH terms:
Blepharoptosis
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013