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临床试验/NCT01838252
NCT01838252撤回4 期

Hyaluronic Acid Gels for Lower Lid Retraction

University of California, Los Angeles2 个研究点 分布在 1 个国家开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Lower eyelid position

研究概览

简要总结

Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting.

Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.

The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity).

Our hypothesis is that HAG correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lower eyelid retraction of >1mm in one or both eyes.
  • Complaints of either significant ocular symptoms (OSDI>13) or cosmetic deformity associated with the eyelid retraction.

排除标准

  • Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population
  • Age over 65 years of age: as HAG filler effect may be different in this population
  • Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers
  • Have a demonstrated allergy to HAG fillers or lidocaine
  • Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it
  • Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.
  • Currently active stage Thyroid Eye Disease

结局指标

主要结局

Lower eyelid position

时间窗: 6 weeks

Decrease in inferior scleral show

次要结局

  • Subjective dry eye symptoms(6 weeks)
  • Objective dry eye signs(6 weeks)

研究者

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

Daniel Rootman

MD

University of California, Los Angeles

研究点 (2)

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