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Completed

NCT Number: NCT00753831

Efficacy of Aurosling in Frontalis Sling Suspension Surgery

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

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Key information

Conditions

Ptosis, Eyelid Blepharoptosis Blepharospasm Cranial Nerve Diseases Eye Diseases Eyelid Diseases Nervous System Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aurosling

Procedure

Silicon rod to be used in frontalis suspension surgery

Primary outcomes

  1. Ptosis Correction

    Time frame: 15th day, 90th day postoperatively

Secondary outcomes

  1. Adverse Events

    Time frame: 15th day, 90th day postoperatively

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 17, 2008
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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