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临床试验/NCT05945615
NCT05945615已完成3 期

Evaluation of Ophthalmic Oxymetazoline as an Adjunct Treatment for Acquired Blepharoptosis Due to Periocular Synkinesis.

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Difference from baseline to end of study in Sunnybrook Grading Score

研究概览

简要总结

After an episode of facial paralysis, as nerves recover, they aberrantly regenerate and send additional branches to the incorrect muscles in addition to the intended muscle. This leads to what is known as Aberrant Regeneration Syndrome, Post-paralysis Synkinesis, or Nonflaccid Facial Paralysis. It is characterized by poor facial symmetry and function, hypertonic facial muscles at rest, and abnormal facial movements. One sequela is acquired blepharoptosis causing a smaller ocular aperture, visual field obstruction, cosmetic deformity, and abnormal periocular spasms. This study aims to evaluate an FDA approved medication for acquired blepharoptosis due to synkinesis/hyperkinesis as an adjunct to treatment.

详细描述

Broadly, synkinesis is a neuromuscular condition in which voluntary muscle contraction causes simultaneous involuntary contraction of other muscle groups e.g. pursing of the lips causes involuntary closure of the eye. It is a common sequelae of facial nerve paralysis with 55% or more of patients reporting synkinetic facial movement. 2 Additionally, patients may develop hyperkinesis due to continual firing of nerves that have aberrantly regenerated, thereby causing decreased movement due to antagonistic muscle hyperactivity, tightness, spasms, and pain. These together significant affect facial symmetry, aesthetics, and facial function.

While the definitive pathophysiology of synkinesis is still unknown, the most supported theory describes neuronal miswiring (aberrant regeneration theory). It suggests that following injury to the facial nerve and Wallerian degeneration, axons from the facial nucleus in the brainstem regrow and form inappropriate connections to peripheral muscle groups (e.g. a nerve meant to control the orbicularis oris of the mouth connects to the orbicularis oculi of the eye as well). This results in involuntary facial movements during normal expression and can affect all muscles of facial expression.

Furthermore, because of continual facial muscular tone or hypertonicity, this is not only a dynamic process, but a static one as well. Synkinesis and hypertonicity can cause facial asymmetry and a fixed immobile face ("frozen facies) due to opposing muscles constantly contracting and limiting movement. The result can be unaesthetic: the eyes may look smaller, the commissure (corner) of the mouth may look deviated up and out, the nasolabial fold may look deeper, the base of the nose may be deviated, the chin may be twisted or dimpled, and a band may be seen in the neck. This also presents functional limitations, such as difficulties in articulation, biting of the lip/cheek, nasal obstruction, incomplete oral competency with drooling, watering of the eye (epiphora) and in controlling facial expressions. Patients notice pain, tightness, poor facial movement, and difficulty expressing emotions, loss of their smile, and embarrassment. These limitations decrease confidence and ultimately the patient's quality of life.

Our study intends to look specifically at periocular synkinesis with orbicularis oculi muscle hypertonicity resulting in acquired blepharoptosis over time (i.e. drooping of the eyelid). Periocular synkinesis is partial closure of the eye due to inappropriate contraction of the orbicularis oculi muscle during other facial movement. Hypertonicity of the orbicularis oculi muscle results in the static narrowing of the palpebral fissure (acquired blepharoptosis) and may cause visual obstruction, asymmetry, and an aged appearance in the affected eye and can occur with both dynamic movement and static tone (hyperkinesis).

This facial movement disorder has no cure. Treatments are intended to improve facial symmetry, decreased tightness/pain, improve function and improve quality of life. These include facial therapy, chemodenervation injections with neurotoxins, and a variety of surgeries. Patients require multimodal therapy. None of these treatments adequately address the acquired blepharoptosis from chronic hyperkinesis and synkinesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Participants in the study will be randomized 2:1 to treatment with oxymetazoline 0.1% or the vehicle solution. Randomization schemes were created by a biostatician. This will be stored in a secure database, only accessible to the investigators. Experimental drops and placebo drops will be removed from their labeled boxes and provided to patients with instructions on use.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age
  • Primary diagnosis of nonflaccid facial paralysis (aberrant regeneration syndrome) and acquired blepharoptosis.

排除标准

  • Patients under the age of 18
  • Patients on cardiac glycosides
  • Patients on MAO inhibitors
  • Patients with angle closure glaucoma
  • Patients who experience asymmetrical eye opening due to weakness (e.g. lagophthalmos).

研究组 & 干预措施

Oxymetazoline 0.1% ophthalmic drops

Experimental

Patients will use once daily in affected eye. Drops are provided in single use vials.

干预措施: Oxymetazoline 0.1% (Pf) Oph Soln Ud (Drug)

Preservative free lubricating drops

Placebo Comparator

Patients will use once daily in affected eye. Drops are provided in single use vials.

干预措施: Preservative free lubricating drops (Other)

结局指标

主要结局

Difference from baseline to end of study in Sunnybrook Grading Score

时间窗: 6 months

Clinician-graded outcome measure

Difference from baseline to end of study in Facial Disability Index

时间窗: 6 months

Disease-specific quality of life measure

Difference from baseline to end of study Synkinesis Assessment Questionnaire

时间窗: 6 months

Patient reported outcome measure

次要结局

  • Difference in palpebral height from baseline to when medication is being used(6 months)
  • Difference in MRD-1 from baseline to when medication is being used(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessyka Lighthall

Chief, Facial Plastic and Reconstructive Surgery, Associate Professor, Department of Otolaryngology-Head and Neck Surgery

Milton S. Hershey Medical Center

研究点 (1)

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