Corneal Wavefront AberrationNCT07518316
Factors Influencing Subjective Visual Quality in Human Eyes
A study testing Corneal Refractive Surgery in people with Corneal Wavefront Aberration and Refractive Errors, run by Tianjin Eye Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Corneal Wavefront Aberration, Refractive Errors
- What is being tested?
- Corneal Refractive Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Factors Influencing Subjective Visual Quality in Normal Human Eyes and Before and After Refractive Surgery
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.
- Conditions
- Corneal Wavefront Aberration, Refractive Errors
- Being tested
- Corneal Refractive Surgery
- Medical subject headings
- Corneal Wavefront Aberration, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Refractive SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Corneal Refractive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Higher-Order Aberrations (HOAs)
Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III.
Units: micrometres (µm)
Measured: 3 months
Effective Optical Zone Diameter
Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm)
Measured: 3 months
Central Corneal Thickness
Central corneal thickness measured using the Pentacam system. Units: micrometres (µm)
Measured: 3 months
Coma Aberration (RMS)
Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Measured: 3 months
Trefoil Aberration (RMS)
Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Measured: 3 months
Spherical Aberration (Zernike Z₄⁰, RMS)
Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III.
Units: micrometres (µm)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start18 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Wavefront AberrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518316
- Sponsor's protocol ID
- KY-2025032
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Subjective Visual Quality in Normal Human Eyes and Before and After Refractive Surgery
- ClinicalTrials.gov ID
- NCT07518316
- Acronym / sponsor ID
- KY-2025032
- Conditions
- Corneal Wavefront Aberration, Refractive Errors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal refractive surgery | Experimental | Procedure: Corneal Refractive SurgeryCorneal refractive surgery aims to correct refractive errors by altering the shape of the anterior surface of the cornea or by changing its refractive properties. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Refractive SurgeryCorneal 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 or surgery | Corneal refractive surgery |
Primary outcome
Total Higher-Order Aberrations (HOAs)
Time frame: 3 months
Root mean square (RMS) of total higher-order aberrations measured using the OPD-Scan III. Units: micrometres (µm)
Effective Optical Zone Diameter
Time frame: 3 months
Effective optical zone diameter measured using the Pentacam system. Units: millimetres (mm)
Central Corneal Thickness
Time frame: 3 months
Central corneal thickness measured using the Pentacam system. Units: micrometres (µm)
Coma Aberration (RMS)
Time frame: 3 months
Coma aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Trefoil Aberration (RMS)
Time frame: 3 months
Trefoil aberration (root mean square) measured using the OPD-Scan III. Units: micrometres (µm)
Spherical Aberration (Zernike Z₄⁰, RMS)
Time frame: 3 months
Spherical aberration expressed as Zernike coefficient Z₄⁰ (RMS), measured using the OPD-Scan III. Units: micrometres (µm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Refractive Surgery in people with Corneal Wavefront Aberration and Refractive Errors, run by Tianjin Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang (86-13602089393, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Higher-Order Aberrations (HOAs) (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.