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Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine
This study has been completed.
Study NCT00864656   Information provided by University of Sao Paulo

First Received on March 17, 2009.   Last Updated on March 18, 2009   History of Changes

March 17, 2009
March 18, 2009
September 2006
March 2009   (final data collection date for primary outcome measure)
Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test [ Time Frame: 3, 10, 15 and 30 minutes ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00864656 on ClinicalTrials.gov Archive Site
Scobee test to detect eye dominance [ Time Frame: 15 minutes before 10% phenylephrine instillation ] [ Designated as safety issue: Yes ]
Same as current
 
Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine
Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
 
Probability Sample

Involutional blepharoptosis patients
Blepharoptosis
 
  • 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
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. Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00864656
phenylephrine test
Yes
Suzana Matayoshi, Clinica Oftalmologica HCFMUSP
University of Sao Paulo
 
Principal Investigator: Suzana Matayoshi, MD Opthalmology Dept.Sao Paulo University General Hospital
University of Sao Paulo
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP




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