the Correlation Between Erin Test and Müller's Muscle-Conjunctival ResectionNCT04150588
The Correlation Between MMCR and Phenylephrine Test
An observational study of the Correlation Between Erin Test and Müller's Muscle-Conjunctival Resection, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The propose of the study is the examine the association between the amount that the eyelid rise 3 months after surgery and the reaction to Efrin test before surgery Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- the Correlation Between Erin Test and Müller's Muscle-Conjunctival Resection
- What is being tested?
- Efrin drops
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Nov 2019to 30 Nov 2022
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ptosis over 18 YO that react to efrin test
Who may be able to join
- patients with ptosis
- patients that react to Efrin test
Who cannot join
- Other eye diseases
- other eye surgeries
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan
Ayelet Priel, 97235302874, priel.ayelet@gmail.com
About this study
Official title: The Correlation Between Müller's Muscle-Conjunctival Resection and Phenylephrine Test
The propose of the study is the examine the association between the amount that the eyelid rise 3 months after surgery and the reaction to Efrin test before surgery
- Being tested
- Efrin drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efrin dropsDrug
The amount that the eyelid rise after Erin drops before surgery
| Study group | Role | What they receive |
|---|---|---|
| Good reaction to Efrin test | Not described Receives: Drug: Efrin drops | |
| Unsatisfied reaction to Efrin test | Not described Receives: Drug: Efrin drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reaction to efrin test before surgery
Measured: 15 minutes
Secondary outcomes (1)
The amount that the eyelid rise after surgery
Measured: 3 MONTHS postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start30 Nov 2019 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Correlation Between Erin Test and Müller's Muscle-Conjunctival ResectionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150588
- Sponsor's protocol ID
- Sheba-19-6248-PA-CTIL
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Müller's Muscle-Conjunctival Resection and Phenylephrine Test
- ClinicalTrials.gov ID
- NCT04150588
- Acronym / sponsor ID
- Sheba-19-6248-PA-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 30 Nov 2019 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 5 Nov 2019 (actual)
- 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 propose of the study is the examine the association between the amount that the eyelid rise 3 months after surgery and the reaction to Efrin test before surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good reaction to Efrin test | – | Drug: Efrin drops |
| Unsatisfied reaction to Efrin test | – | Drug: Efrin drops |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ptosis over 18 YO that react to efrin test
Key inclusion criteria (2 listed)
- patients with ptosis
- patients that react to Efrin test
Key exclusion criteria (2 listed)
- Other eye diseases
- other eye surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efrin dropsThe amount that the eyelid rise after Erin drops before surgery | Drug | Good reaction to Efrin test, Unsatisfied reaction to Efrin test |
Primary outcome
The reaction to efrin test before surgery
Time frame: 15 minutes
1 secondary outcome
The amount that the eyelid rise after surgery
Time frame: 3 MONTHS postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Undecided
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.
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 the Correlation Between Erin Test and Müller's Muscle-Conjunctival Resection, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reaction to efrin test before surgery (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2019; AzTrials last refreshed its copy on 3 Nov 2026.