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

NCT ID: NCT00864656

Last Updated: 2009-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blepharoptosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Patients submitted to application of 1 drop of 10% phenylephrine

No interventions assigned to this group

2

Patients submitted to application of 2 drops of 10% phenylephrine

No interventions assigned to this group

3

Patients submitted to application of 4 drops of 10% phenylephrine

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clinica Oftalmologica HCFMUSP

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzana Matayoshi, MD

Role: PRINCIPAL_INVESTIGATOR

Opthalmology Dept.Sao Paulo University General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ophthalmology Dept. University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1590/s0004-27492008000500006. Portuguese.

Reference Type BACKGROUND
PMID: 19039456 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

phenylephrine test

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eye Pressure Lowering Surgery
NCT01931904 RECRUITING