NCT07518316

Factors Influencing Subjective Visual Quality in Human Eyes

Factors Influencing Subjective Visual Quality in Normal Human Eyes and Before and After Refractive Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Wavefront Aberration
• Refractive Errors

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2026-03-18
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-04-08
• Last updated: 2026-04-08