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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00864656
Other study ID # phenylephrine test
Secondary ID
Status Completed
Phase N/A
First received March 17, 2009
Last updated March 18, 2009
Start date September 2006
Est. completion date March 2009

Study information

Verified date March 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Ophthalmology Dept. University of Sao Paulo General Hospital Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

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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