Corneal refractive surgery
ProcedureCorneal refractive surgery aims to correct refractive errors by altering the shape of the anterior surface of the cornea or by changing its refractive properties.
NCT Number: NCT07518316
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III.
Units: micrometres (µm)
Time frame: 3 months
Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm)
Time frame: 3 months
Central corneal thickness measured using the Pentacam system. Units: micrometres (µm)
Time frame: 3 months
Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Time frame: 3 months
Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Time frame: 3 months
Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III.
Units: micrometres (µm)
Contact information is provided by the study sponsor or research team.
Shufan Wang
CONTACT
Yan Wang
CONTACT
Tianjin Eye Hospital
Other
Factors Influencing Subjective Visual Quality in Normal Human Eyes and Before and After Refractive Surgery
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