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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864656
• Other study ID #: phenylephrine test
• 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

• Blepharoptosis

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