Factors Influencing Subjective Visual Quality in Normal Human Eyes and Before and After Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Total Higher-Order Aberrations (HOAs)
研究概览
简要总结
To assess subjective visual symptoms using the QoV questionnaire, measure pupil size using the Atongmu Pupillometer, measure wavefront aberrations using the OPD-Scan III Aberrometer, and measure/calculate the effective optical zone using the Pentacam system. The relationships between pupil size, higher-order aberrations (HOAs), effective optical zone after refractive surgery, and subjective visual symptoms will be explored.
详细描述
The sample size will be calculated using an appropriate sample size calculation formula. Using a random number table method, 1200 subjects scheduled for preoperative examination at the Refractive Surgery Center of Tianjin Eye Hospital between December 1, 2025, and May 1, 2026, will be randomly selected. Data including age, gender, spectacle wear status, uncorrected visual acuity (UCVA), spherical power, cylindrical power, intraocular pressure (IOP), mean keratometry (Km), corneal thickness, axial length, and degree of lens and vitreous opacities will be recorded. Pupil size under photopic, mesopic, and scotopic conditions will be measured using the Atongmu Pupillometer. Wavefront aberrations will be measured using the OPD-Scan III Aberrometer (OPD: Optical Path Difference). Subjects will complete the Quality of Vision (QoV) questionnaire.
Additionally, based on sample size calculation, using a random number table method, 300 subjects undergoing refractive surgery at the Refractive Surgery Center of Tianjin Eye Hospital between December 1, 2025, and May 1, 2026, will be randomly selected and prospectively followed up until 3 months postoperatively. Pupil size under photopic, mesopic, and scotopic conditions will be measured using the Atongmu Pupillometer. Wavefront aberrations will be measured using the OPD-Scan III Aberrometer before and after surgery. The effective optical zone (EOZ) will be measured and calculated using the Pentacam three-dimensional anterior segment analysis system. The QoV questionnaire will be administered postoperatively. Data will be collated and analyzed using statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic or myopic astigmatism patients aged 18 to 45 years.
- •Transparent ocular media, absence of ocular diseases such as corneal leucoma, cataract, etc.
- •Round pupils with normal light reflex, absence of dyscoria, corectopia, significant persistent pupillary membrane, or absence of the pupil.
- •Absence of severe psychological or psychiatric disorders, ability to cooperate with examinations and questionnaire completion.
- •Subject agrees to participate in this clinical study and cooperate with examinations and related procedures.
排除标准
- •Opacities of the ocular media, such as corneal leucoma, cataract, etc.
- •Pupil deformation, displacement, significant persistent pupillary membrane, or absence of the pupil.
- •Severe psychological or psychiatric disorders.
- •Concurrent diagnosis of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis, etc.).
- •History of ocular surgery or trauma.
- •Nystagmus or inability to cooperate.
研究组 & 干预措施
Corneal refractive surgery
Corneal refractive surgery aims to correct refractive errors by altering the shape of the anterior surface of the cornea or by changing its refractive properties.
干预措施: Corneal Refractive Surgery (Procedure)
结局指标
主要结局
Total Higher-Order Aberrations (HOAs)
时间窗: 3 months
Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III. Units: micrometres (µm)
Effective Optical Zone Diameter
时间窗: 3 months
Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm)
Central Corneal Thickness
时间窗: 3 months
Central corneal thickness measured using the Pentacam system. Units: micrometres (µm)
Coma Aberration (RMS)
时间窗: 3 months
Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Trefoil Aberration (RMS)
时间窗: 3 months
Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Spherical Aberration (Zernike Z₄⁰, RMS)
时间窗: 3 months
Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III. Units: micrometres (µm)
次要结局
未报告次要终点