Efficacy of Aurosling in Frontalis Sling Suspension Surgery

• Sponsor: Aurolab (Other)
• Overall Status: Completed
• CT.gov ID: NCT00753831
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• 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: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ptosis Correction [15th day, 90th day postoperatively]

Secondary Outcome Measures

1. Adverse Events [15th day, 90th day postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aravind Eye Hospital	Madurai	Tamil Nadu	India	625020

Sponsors and Collaborators

• Aurolab

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aurolab
• ClinicalTrials.gov Identifier: NCT00753831
• Other Study ID Numbers: 2PR1220827
• First Posted: Sep 17, 2008
• Last Update Posted: Jul 12, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Aurolab: Blepharoptosis; Ophthalmoplegia; Blepharospasm
• Additional relevant MeSH terms: Blepharoptosis

Study Results

No Results Posted as of Jul 12, 2012