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Efficacy of Aurosling in Frontalis Sling Suspension Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00753831
Enrollment
16
Registered
2008-09-17
Start date
2009-01-31
Completion date
2009-08-31
Last updated
2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ptosis, Eyelid

Keywords

Blepharoptosis, Ophthalmoplegia, Blepharospasm

Brief summary

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

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

Interventions

PROCEDUREAurosling

Silicon rod to be used in frontalis suspension surgery

Sponsors

Aurolab
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Ptosis Correction15th day, 90th day postoperatively

Secondary

MeasureTime frame
Adverse Events15th day, 90th day postoperatively

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026