Ptosis, EyelidPhase 4NCT05890027
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
A Phase 4 study testing Phenylephrine Ophthalmic and Eyelid Tape in people with Ptosis, Eyelid, run by University of Miami at 1 site in United States.
Trial summary
This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ptosis, Eyelid
- What is being tested?
- Phenylephrine Ophthalmic and Eyelid Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 1 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation.
- Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution.
- Individuals who can tolerate eye-drop medications.
- Individuals who are physically able to take a tangent screen visual field test.
- Age: Adults who can comprehend the instructions and procedures (18+ years old)
Who cannot join
- This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
- This study will not include participants who refuse to consent.
- This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects).
- This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution.
- Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease
- This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Bascom Palmer Eye Institute
Miami, Florida, 33136
About this study
Official title: Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.
- Conditions
- Ptosis, Eyelid
- Being tested
- Phenylephrine Ophthalmic, Eyelid Tape
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine OphthalmicDrug
One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.
Eyelid TapeOther
Participants will have the affected eye with ptosis manually lifted using tape.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine and Eye Taping Group | Experimental | Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes. Receives: Drug: Phenylephrine Ophthalmic; Other: Eyelid Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean MRD1 After Phenylephrine
Margin to Reflex Distance 1 measured at least ten minutes after administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye. Measured in mm.
Measured: 10 minutes after phenylephrine instillation.
Mean Change in MRD1 Between Baseline and Phenylephrine
Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.
Measured: Baseline, 10 minutes after phenylephrine instillation.
Mean Superior Visual Field After Taping
Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.
Measured: Baseline, Within 1 minute after upper eyelid taping.
Mean Change in Superior Visual Field After Taping
Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.
Measured: Baseline, Within 1 minute after upper eyelid taping.
Count of Eyes That Met Insurance Criteria After Taping
Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).
Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and taping of the upper eyelid.
Measured: Baseline, Within 1 minute after upper eyelid taping.
Mean Superior Visual Field After Phenylephrine
Degree of ptosis as measured by a tangent screen superior visual field test ten minutes after the administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye.
Measured: 10 minutes after phenylephrine instillation.
Mean Change in Superior Visual Field After Phenylephrine
Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.
Measured: Baseline, 10 minutes after phenylephrine instillation.
Count of Eyes That Met Insurance Criteria After Phenylephrine
Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).
Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and phenylephrine ophthalmic solution instillation.
Measured: Baseline, 10 minutes after phenylephrine instillation.
Secondary outcomes (3)
Mean Participant Satisfaction Score After Taping
After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.
Measured: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Participant Satisfaction Score After Phenylephrine
After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.
Measured: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine
After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.
Measured: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start19 Mar 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ptosis, EyelidStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara T. Wester, University of Miami
- Investigators
- Sara T Wester, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890027
- Sponsor's protocol ID
- 20230019
- Status last verified
- Aug 2025
- First submitted
- 25 May 2023
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaur M, Leveille LA, Alabiad CR, Rong AJ, Wester ST. Preoperative Ptosis Evaluation: A Comparative Analysis of Phenylephrine Drops and Eyelid Taping for Visual Field Testing. Ophthalmic Plast Reconstr Surg. 2026 Apr 23. doi: 10.1097/IOP.0000000000003204. Online ahead of print.
PubMed 42024579
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
- ClinicalTrials.gov ID
- NCT05890027
- Acronym / sponsor ID
- 20230019
- Conditions
- Ptosis, Eyelid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine and Eye Taping Group | Experimental | Drug: Phenylephrine Ophthalmic, Other: Eyelid TapeParticipants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation.
- Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution.
- Individuals who can tolerate eye-drop medications.
- Individuals who are physically able to take a tangent screen visual field test.
- Age: Adults who can comprehend the instructions and procedures (18+ years old)
Key exclusion criteria (6 listed)
- This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
- This study will not include participants who refuse to consent.
- This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects).
- This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution.
- Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine OphthalmicOne drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair. | Drug | Phenylephrine and Eye Taping Group |
| Eyelid TapeParticipants will have the affected eye with ptosis manually lifted using tape. | Other | Phenylephrine and Eye Taping Group |
Primary outcome
Mean MRD1 After Phenylephrine
Time frame: 10 minutes after phenylephrine instillation.
Margin to Reflex Distance 1 measured at least ten minutes after administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye. Measured in mm.
Mean Change in MRD1 Between Baseline and Phenylephrine
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.
Mean Superior Visual Field After Taping
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.
Mean Change in Superior Visual Field After Taping
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.
Count of Eyes That Met Insurance Criteria After Taping
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline). Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and taping of the upper eyelid.
Mean Superior Visual Field After Phenylephrine
Time frame: 10 minutes after phenylephrine instillation.
Degree of ptosis as measured by a tangent screen superior visual field test ten minutes after the administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye.
Mean Change in Superior Visual Field After Phenylephrine
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.
Count of Eyes That Met Insurance Criteria After Phenylephrine
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline). Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and phenylephrine ophthalmic solution instillation.
3 secondary outcomes
Mean Participant Satisfaction Score After Taping
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Participant Satisfaction Score After Phenylephrine
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42024579Kaur M, Leveille LA, Alabiad CR, Rong AJ, Wester ST. Preoperative Ptosis Evaluation: A Comparative Analysis of Phenylephrine Drops and Eyelid Taping for Visual Field Testing. Ophthalmic Plast Reconstr Surg. 2026 Apr 23. doi: 10.1097/IOP.0000000000003204. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Sara T Wester, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine Ophthalmic and Eyelid Tape in people with Ptosis, Eyelid, run by University of Miami at 1 site in United States.
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 5 inclusion and 6 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 22 Aug 2025. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean MRD1 After Phenylephrine (time frame: 10 minutes after phenylephrine instillation.). The study lists 8 primary outcomes in all. 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 NCT05890027, 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 22 Aug 2025.