BlepharoptosisNCT00864656
Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine
An observational study of Blepharoptosis, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blepharoptosis
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Involutional blepharoptosis patients
Who may be able to join
- Involutional blepharoptosis
- Upper Margin-reflex distance less or equal 2.0mm
- Good fixation and collaboration
Who cannot join
- Previous eyelid surgeries
- Use of adrenergic or sympathicomimetics drugs
- Myopathies
- Thyroid orbitopathy
- Non-controlled cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ophthalmology Dept. University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403010
About this study
Official title: Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 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.
Read the detailed 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.
- Conditions
- Blepharoptosis
- Keywords
- adrenergic alpha-agonists, phenylephrine, drug effects, diagnostic use
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients submitted to application of 1 drop of 10% phenylephrine | |
| 2 | Patients submitted to application of 2 drops of 10% phenylephrine | |
| 3 | Patients submitted to application of 4 drops of 10% phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test
Measured: 3, 10, 15 and 30 minutes
Secondary outcomes (1)
Scobee test to detect eye dominance
Measured: 15 minutes before 10% phenylephrine instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startSep 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Suzana Matayoshi, MD, Principal investigator, Opthalmology Dept.Sao Paulo University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864656
- Sponsor's protocol ID
- phenylephrine test
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19039456
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine
- ClinicalTrials.gov ID
- NCT00864656
- Acronym / sponsor ID
- phenylephrine test
- Conditions
- Blepharoptosis
- Keywords
- adrenergic alpha-agonists, phenylephrine, drug effects, diagnostic use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients submitted to application of 1 drop of 10% phenylephrine |
| 2 | – | –Patients submitted to application of 2 drops of 10% phenylephrine |
| 3 | – | –Patients submitted to application of 4 drops of 10% phenylephrine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Involutional blepharoptosis patients
Key inclusion criteria (3 listed)
- Involutional blepharoptosis
- Upper Margin-reflex distance less or equal 2.0mm
- Good fixation and collaboration
Key exclusion criteria (5 listed)
- Previous eyelid surgeries
- Use of adrenergic or sympathicomimetics drugs
- Myopathies
- Thyroid orbitopathy
- Non-controlled cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test
Time frame: 3, 10, 15 and 30 minutes
1 secondary outcome
Scobee test to detect eye dominance
Time frame: 15 minutes before 10% phenylephrine instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
- Background: PubMed 19039456Nunes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzana Matayoshi, MD principal investigator
Opthalmology Dept.Sao Paulo University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharoptosis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test (time frame: 3, 10, 15 and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.