Efficacy of Aurosling in Frontalis Sling Suspension Surgery

Ptosis, Eyelid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753831
• Other study ID #: 2PR1220827
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: July 11, 2012
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: July 2012
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharoptosis
• Ptosis, Eyelid

Intervention

Procedure:
• Aurosling
Silicon rod to be used in frontalis suspension surgery

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ptosis Correction		15th day, 90th day postoperatively	No
Secondary	Adverse Events		15th day, 90th day postoperatively	Yes