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Phenylephrine vs Eyelid Taping for Drooping Eyelid
Phase 4
Recruiting
Led By Sara T Wester, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 60 minutes
Awards & highlights
Study Summary
This trial aims to see if eye drops can better measure drooping eyelids, compared to tape, when deciding if surgery is needed.
Who is the study for?
Adults aged 18-90 with drooping eyelids (ptosis) who are evaluating surgery for this condition can join. They must understand the study, be able to do a visual field test, and not have allergies to phenylephrine eye drops. People taking certain drugs like Ergot derivatives or with specific heart conditions cannot participate.Check my eligibility
What is being tested?
The trial is testing if Phenylephrine eye drops are better than using tape to lift the eyelid for assessing how much ptosis blocks vision before eyelid surgery. Participants will try both methods so researchers can compare which predicts surgical outcomes best.See study design
What are the potential side effects?
Phenylephrine may cause temporary side effects such as stinging in the eyes, increased blood pressure, headache, or palpitations. It's important that participants don't have conditions that could worsen with these potential reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ptosis as measured by the margin to reflex distance 1 (MRD1)
Change in ptosis as measured by the tangent screen visual field test
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phenylephrine and Eye Taping GroupExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,046 Total Patients Enrolled
Sara T Wester, MDPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use certain eye drops due to my heart or blood pressure conditions.I am under the age of 18.I am unable to give consent for medical procedures.I am being evaluated for a specific eyelid surgery due to droopy eyelids.I can use eye-drop medications without any issues.I am not allergic to phenylephrine eye drops.I am too tired or unable to take a specific eye test.I do not agree to participate in this study.I can perform a visual field test.I do not take medications that react badly with phenylephrine.I am between 18 and 90 years old and can understand the study instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Phenylephrine and Eye Taping Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any risk associated with the administration of Phenylephrine and Eye Taping Group?
"As this intervention has already been approved, the safety of Phenylephrine and Eye Taping Group was assigned a 3 out of 3 on our scale."
Answered by AI
Does this medical trial accept participants over the age of twenty?
"The criteria for eligibility in this trial requires that applicants are between 18 and 90 years old. Additionally, there are 2 trials geared towards minors while 5 studies target individuals over the age of 65."
Answered by AI
Who is qualified to become a participant in this research?
"This trial is seeking around 30 volunteers with a diagnosis of ptosis and who are in the age bracket between 18 to 90 years old."
Answered by AI
Are there any opportunities for individuals to join this clinical research?
"According to clinicaltrials.gov, this medical trial is not presently recruiting participants. This research was first published in July of 2023 and had its last update on May 25th of the same year. Despite this study's lack of recruitment at present, there are 5 other trials with current vacancies for patients."
Answered by AI
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