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Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine

U

University of Sao Paulo

Status

Completed

Conditions

Blepharoptosis

Study type

Observational

Funder types

Other

Identifiers

NCT00864656
phenylephrine test

Details and patient eligibility

About

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.

Full description

This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3).

Video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.

Enrollment

60 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

60 participants in 3 patient groups

1
Description:
Patients submitted to application of 1 drop of 10% phenylephrine
2
Description:
Patients submitted to application of 2 drops of 10% phenylephrine
3
Description:
Patients submitted to application of 4 drops of 10% phenylephrine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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