NCT00753831

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

September 16, 2008

Last Update Submit

July 11, 2012

Conditions

Ptosis, Eyelid

Keywords

BlepharoptosisOphthalmoplegiaBlepharospasm

Outcome Measures

Primary Outcomes (1)

  • Ptosis Correction

    15th day, 90th day postoperatively

Secondary Outcomes (1)

  • Adverse Events

    15th day, 90th day postoperatively

Study Arms (1)

1

EXPERIMENTAL

Aurosling

Procedure: Aurosling

Interventions

AuroslingPROCEDURE

Silicon rod to be used in frontalis suspension surgery

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

MeSH Terms

Conditions

BlepharoptosisOphthalmoplegiaBlepharospasm

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Usha Kim, DO, Dip NB

    Aravind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 17, 2008

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

IN(1)