Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Goldmann Applanation Intraocular Pressure
研究概览
简要总结
This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye.
详细描述
Subjects first present for a single qualification visit (phase 1), then present for up to 3 short-term (~1 hour) in-clinic visits (phase 2), and finally have visits prior to and following a full day (phase 3). Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact lens are compared to those of traditional soft contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Glaucomatous Arm Inclusion Criteria
- •22+ years of age
- •Able to wear soft contact lenses
- •Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG)
- •Non-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria
- •22+ years of age
- •Able to wear soft contact lenses
- •Without glaucomatous disease
排除标准
- •for all arms:
- •Unable to complete the study procedures
- •Ocular disease other than glaucoma (if applicable)
- •Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study and/or is contradicted for soft contact lens or sensor lens use
结局指标
主要结局
Goldmann Applanation Intraocular Pressure
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A \>2 mmHg difference in is considered clinically significantly different.
I-Care Tonometry Intraocular Pressure
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A \>2 mmHg difference in is considered clinically significantly different.
Lens comfort
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable/intolerable and a rating of '1' perfectly comfortable/not noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different.
Lens Fit
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant.
Goldmann Applanation Intraocular Pressure
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A \>2 mmHg difference in is considered clinically significantly different.
I-Care Tonometry Intraocular Pressure
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A \>2 mmHg difference in is considered clinically significantly different.
Lens comfort
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable/intolerable and a rating of '1' perfectly comfortable/not noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different.
Lens Fit
时间窗: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant.
次要结局
未报告次要终点
研究者
Pete Kollbaum, OD, PhD
Associate Dean
Indiana University