Efficacy of Aurosling in Frontalis Sling Suspension Surgery

Aurolab

Status and phase: Completed; Phase 4

Conditions: Ptosis, Eyelid

Treatments: Procedure: Aurosling

Study type: Interventional

Funder types: Other

Identifiers

NCT00753831

2PR1220827

Details and patient eligibility

About

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

Full 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

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

1

Experimental group

Description:

Aurosling

Treatment:

Procedure: Aurosling