Blepharoptosis Clinical Trial
Official title:
Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine
Verified date | March 2009 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Ophthalmology Dept. University of Sao Paulo General Hospital | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test | 3, 10, 15 and 30 minutes | Yes | |
Secondary | Scobee test to detect eye dominance | 15 minutes before 10% phenylephrine instillation | Yes |
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