NCT06781931Withheld不适用
[Trial of device that is not approved or cleared by the U.S. FDA]
[Redacted]10 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年1月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Withheld
- 发起方
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- Co-Primary Effectiveness Endpoints: Spherical equivalent refraction and Axial Length
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children.
- To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period.
- To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period.
The clinical trial will compare DG1 spectacle lens to single vision spectacle lens.
Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and parent (or guardian) able and willing to provide assent and consent respectively.
- •The subject and parent (or guardian) must attend required study visits and adhere to study requirements.
- •Parent (or guardian) understands and accepts random allocation of grouping, and that subject and parent (or guardian) will not be told the group which the subject is randomized to.
- •The subject is able and willing to wear provided frames and lenses (spectacles), for an average of 10 hours per day for the entirety of the study.
- •Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive).
- •Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 D in each eye at the screening visit.
- •Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at the screening visit.
- •Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit.
- •Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to or better than log MAR 0.10 in each eye at the screening visit.
排除标准
- •Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate or tropicamide eye drops.
- •Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development.
- •Subjects who have received treatment of myopia control pharmaceutical medication (e.g., atropine), myopia control contact lenses, other myopia control spectacles, orthokeratology lenses, progressive addition lenses, bifocal lenses, or single vision contact lens prior to entry into the study or during the duration of the study.
- •Subjects with, or a medical history of, strabismus.
- •Subjects with a medical history of binocular vision abnormalities or accommodation abnormalities based on the opinion of the investigator.
- •Subjects with, or history of, amblyopia.
- •Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation.
- •Subjects with a history of intraocular surgery.
- •Subjects who, in the judgment of the investigator, have any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- •Subjects with pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy).
- •Individuals from the same household (i.e., siblings), employees (or family members of employees) of the Principal Investigator/site, employees (or family members of employees) of the Sponsor, and non-readers.
研究组 & 干预措施
Single Vision Spectacle Lens
Sham Comparator
干预措施: Single Vision Spectacle Lens (Device)
DG1 Spectacle Lens
Experimental
干预措施: DG1 Spectacle Lens (Device)
结局指标
主要结局
Co-Primary Effectiveness Endpoints: Spherical equivalent refraction and Axial Length
时间窗: 36 months
* The mean difference of cycloplegic autorefractive error progression of the test device as compared to control SV spectacles. * The mean difference in axial elongation of the test device as compared to control SV spectacles.
次要结局
- Corrected Visual Acuity(24 months)
研究者
研究点 (10)
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