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临床试验/NCT02612584
NCT02612584已完成不适用

Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

Yonsei University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Defocusing curve

研究概览

简要总结

For correct of presbyopia, in this study, the investigators have recruited subjects who aged 45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent ophthalmic examination including manifest refraction, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on dominant eye of participants. The investigators recommend use of pinhole contact lens at least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic examination same above 2 weeks after first apply of pinhole contact lens. The investigators will compare ophthalmic parameters mentioned above before and after wearing pinhole contact lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting presbyopia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age, 45~65 years with presbyopia

排除标准

  • Patients with anterior segment pathology,
  • Patients with previous intraocular or corneal surgery,
  • Patients with severe cataracts,
  • Patients with corneal abnormalities( including endothelial dystrophy, recurrent corneal erosion, etc.),
  • Patients with history of chronic dry eye, macular degeneration,
  • Patients with retinal detachment, or any other fundus pathology

结局指标

主要结局

Defocusing curve

时间窗: 2 weeks after first apply of pinhole contact lens

Corrected (with pinhole contact lens) Near Vision Acuity

时间窗: 2 weeks after first apply of pinhole contact lens

次要结局

  • Contrast sensitivity test(2 weeks after first apply of pinhole contact lens)
  • OSDI(ocular surface disease index)(2 weeks after first apply of pinhole contact lens)
  • Visual field test(2 weeks after first apply of pinhole contact lens)
  • Corneal erosion grade(oxford score)(2 weeks after first apply of pinhole contact lens)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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