Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Epico, LLC
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.
研究概览
简要总结
The EpiGlare Tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (BSCVA).
详细描述
Inclusion Criteria:
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Are 18 years of age or older.
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Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.
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Normal = lens opacity of clear or trace
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Cataract = lens opacity of 2+ or greater
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Have written informed consent as required by the site's IRB and received a copy.
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Are willing and able to comply with testing according to the Investigator.
Exclusion Criteria:
- Best corrected visual acuity is worse than 20/60 in either eye
- Have occular pathology including corneal or macular disease or advanced glaucoma
- Have cognitive dysfunction which limits the ability to cooperate with testing.
- Have presence or history of any other condition or finding or concomitant medication that, in the investigator's opinion, makes the subject unsuitable as a candidate for EpiGlare or study participation or may confound the outcome of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clear lenses OU cataracts OU willing to comply with testing
排除标准
- •BCVA < 20/63 either eye ocular pathology (ie corneal, macular disease, advanced glaucoma) cognitive dysfunction other conditions that in the investigators opinion made the subject unsuitable candidate
结局指标
主要结局
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.
时间窗: up to 16 months
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source in patients with and without cataracts.
次要结局
- Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire(up to 16 months)