Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia
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
- 否
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)
