NCT06991127招募中不适用
Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 6
- 主要终点
- To determine the reference normative values of retinal sensitivity for MAIA
研究概览
简要总结
The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age: ≥18 years old;
- •Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
- •Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
- •Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
- •Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
- •Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
- •No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
- •Absence of pathologies that can affect visual field in both eyes;
- •No use of drugs interfering with the correct execution of perimetry.
排除标准
- •Glaucoma or glaucoma suspect diagnosis in either eye;
- •Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
- •Presence or history of disc hemorrhage in either eye;
- •Presence of amblyopia in either eye;
- •Nystagmus or poor fixation in either eye;
- •Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
- •Any active infection of anterior or posterior segments in the study eye;
- •Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
- •Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
- •Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
- •Unable to tolerate ophthalmic imaging;
- •Claustrophobia;
- •Inability to provide informed consent.
结局指标
主要结局
To determine the reference normative values of retinal sensitivity for MAIA
时间窗: 1 day
The reference normative values will be determined by using a linear regression model for Mean Sensitivity (MS) as a function of age. The 5th and 10th percentile values will be derived for each age, and will serve as age-adjusted normative data against which compare the MS computed during each test with MAIA
次要结局
- To assess the avoidance of Serious Adverse Device Effects with MAIA(through study completion (expected duration: 10 months))
研究者
研究点 (6)
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