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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00864656
First received: March 17, 2009
Last updated: March 18, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition
Blepharoptosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Scobee test to detect eye dominance [ Time Frame: 15 minutes before 10% phenylephrine instillation ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Involutional blepharoptosis patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864656

Locations
Brazil
Ophthalmology Dept. University of Sao Paulo General Hospital
Sao Paulo, Brazil, 05403010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Suzana Matayoshi, MD Opthalmology Dept.Sao Paulo University General Hospital
  More Information

Publications:

Responsible Party: Suzana Matayoshi, Clinica Oftalmologica HCFMUSP
ClinicalTrials.gov Identifier: NCT00864656     History of Changes
Other Study ID Numbers: phenylephrine test
Study First Received: March 17, 2009
Last Updated: March 18, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
adrenergic alpha-agonists
phenylephrine
drug effects
diagnostic use

Additional relevant MeSH terms:
Blepharoptosis
Eyelid Diseases
Eye Diseases
Adrenergic alpha-Agonists
Phenylephrine
Oxymetazoline
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013