NCT00864656

Brief Summary

The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

2.5 years

First QC Date

March 17, 2009

Last Update Submit

March 18, 2009

Conditions

Blepharoptosis

Keywords

adrenergic alpha-agonistsphenylephrinedrug effectsdiagnostic use

Outcome Measures

Primary Outcomes (1)

  • Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test

    3, 10, 15 and 30 minutes

Secondary Outcomes (1)

  • Scobee test to detect eye dominance

    15 minutes before 10% phenylephrine instillation

Study Arms (3)

1

Patients submitted to application of 1 drop of 10% phenylephrine

2

Patients submitted to application of 2 drops of 10% phenylephrine

3

Patients submitted to application of 4 drops of 10% phenylephrine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Involutional blepharoptosis patients

You may qualify if:

  • Involutional blepharoptosis
  • Upper Margin-reflex distance less or equal 2.0mm
  • Good fixation and collaboration

You may not qualify if:

  • Previous eyelid surgeries
  • Use of adrenergic or sympathicomimetics drugs
  • Myopathies
  • Thyroid orbitopathy
  • Non-controlled cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Dept. University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (1)

  • Nunes TP, Matayoshi S. [Phenylephrine 10% eye drop action in the eyelid position in healthy subjects]. Arq Bras Oftalmol. 2008 Sep-Oct;71(5):639-43. doi: 10.1590/s0004-27492008000500006. Portuguese.

    PMID: 19039456BACKGROUND

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Suzana Matayoshi, MD

    Opthalmology Dept.Sao Paulo University General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

September 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

BR(1)