Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mean MRD1 After Phenylephrine
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Phenylephrine and Eye Taping Group
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.
干预措施: Phenylephrine Ophthalmic (Drug)
Phenylephrine and Eye Taping Group
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.
干预措施: Eyelid Tape (Other)
结局指标
主要结局
Mean MRD1 After Phenylephrine
时间窗: 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 Superior Visual Field After Taping
时间窗: 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.
Mean Change in MRD1 Between Baseline and Phenylephrine
时间窗: 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
时间窗: 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.
Count of Eyes That Met Insurance Criteria After Taping
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Mean Participant Satisfaction Score After Taping(Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.)
- Mean Participant Satisfaction Score After Phenylephrine(Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.)
- Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine(Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.)
研究者
Sara T. Wester
Professor of Clinical
University of Miami