Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 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.

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Key information

Conditions

Blepharoptosis Eye Diseases Eyelid Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology Dept. University of Sao Paulo General Hospital

São Paulo, 05403010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 3, 10, 15 and 30 minutes

Secondary outcomes

Scobee test to detect eye dominance

Time frame: 15 minutes before 10% phenylephrine instillation

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Mar 19, 2009
Registry last updated: Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed