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Not yet recruitingNCT07518316Updated Apr 8, 2026

Factors Influencing Subjective Visual Quality in Human Eyes

An interventional study of Corneal Refractive Surgery in Corneal Wavefront Aberration and Refractive Errors, sponsored by Tianjin Eye Hospital. Not yet recruiting. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Corneal Wavefront Aberration
  • Refractive Errors

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03

In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's planned enrollment of 300 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Corneal Refractive Surgery

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.

06

What researchers measure

Primary outcomes

  1. Total Higher-Order Aberrations (HOAs)

    Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III. Units: micrometres (µm)

    Time frame: 3 months

  2. Effective Optical Zone Diameter

    Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm)

    Time frame: 3 months

  3. Central Corneal Thickness

    Central corneal thickness measured using the Pentacam system. Units: micrometres (µm)

    Time frame: 3 months

  4. Coma Aberration (RMS)

    Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)

    Time frame: 3 months

  5. Trefoil Aberration (RMS)

    Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)

    Time frame: 3 months

  6. Spherical Aberration (Zernike Z₄⁰, RMS)

    Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III. Units: micrometres (µm)

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518316
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Mar 18, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Yan Wang
Contact
wangyan7143@vip.sina.com
86-13602089393
Shufan Wang
Contact
wangshufan2049@163.com
86-13376966029

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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