NCT07518316

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

December 12, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

December 12, 2025

Last Update Submit

April 4, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Total Higher-Order Aberrations (HOAs)

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

    3 months

  • Effective Optical Zone Diameter

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

    3 months

  • Central Corneal Thickness

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

    3 months

  • Coma Aberration (RMS)

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

    3 months

  • Trefoil Aberration (RMS)

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

    3 months

  • Spherical Aberration (Zernike Z₄⁰, RMS)

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

    3 months

Study Arms (1)

Corneal refractive surgery

EXPERIMENTAL

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

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.

Corneal refractive surgery

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Wavefront AberrationRefractive Errors

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

April 8, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share