NCT04875234尚未招募不适用
Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Best spectacle-corrected distance visual acuity (BCDVA)
研究概览
简要总结
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.
详细描述
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Patient is at least 50 years old.
- •Patient must have dry AMD in the study eye.
- •Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
- •Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
- •Patient is not a contact lens wearer.
- •Patient is willing and able to comply with all examinations.
- •Patient must be competent to sign an informed consent form before study entry.
排除标准
- •Visually significant cataract in the study eye
- •Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
- •Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
- •Previous corneal surgery in the study eye
- •Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study
结局指标
主要结局
Best spectacle-corrected distance visual acuity (BCDVA)
时间窗: 12 months post-treatment
BCDVA measured using ETDRS eye charts
次要结局
未报告次要终点
研究者
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