Efficacy of Aurosling in Frontalis Sling Suspension Surgery

July 11, 2012 updated by: Aurolab

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Aravind Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ptosis Correction
Time Frame: 15th day, 90th day postoperatively
15th day, 90th day postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 15th day, 90th day postoperatively
15th day, 90th day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

  • Principal Investigator: Usha Kim, DO, Dip NB, Aravind Eye Hospital, Madurai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2PR1220827

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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