Corneal Wavefront Aberration, Refractive Errors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECorneal 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.
Sponsors
Tianjin Eye Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Higher-Order Aberrations (HOAs) | 3 months | Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III. Units: micrometres (µm) |
| Effective Optical Zone Diameter | 3 months | Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm) |
| Central Corneal Thickness | 3 months | Central corneal thickness measured using the Pentacam system. Units: micrometres (µm) |
| Coma Aberration (RMS) | 3 months | Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm) |
| Trefoil Aberration (RMS) | 3 months | Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm) |
| Spherical Aberration (Zernike Z₄⁰, RMS) | 3 months | Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III. Units: micrometres (µm) |
Contacts
CONTACTYan Wang
CONTACTShufan Wang
Outcome results
None listed