Refractive SurgeryNCT07146828
Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery
A study testing Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) in people with Refractive Surgery, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
In recent years, the incidence of myopia has been high globally and is exhibiting a rapid upward trend, with projections estimating it will reach 49.8% by 2050. Corneal refractive surgery has become a primary method for correcting myopia, demonstrating significant efficacy and favorable safety. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Refractive Surgery
- What is being tested?
- Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Oct 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- Age: 18 to 40 years old;
- Optimal preoperative corrected visual acuity >= 4.8;
- More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- Patients who are willing to perform SMILE surgery
Who cannot join
- Patients with history of eye surgery and trauma;
- Patients with keratoconus tendency;
- systemic connective tissue diseases and autoimmune diseases;
- Patients with high blood pressure, diabetes and heart disease history;
- Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
- Patients with scar constitution.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Binocular Wavefront Optometry Machine
Nantong, Jiangsu, 226001
enze Liu, MD, +86 15233615173, 190929031@qq.com
About this study
In recent years, the incidence of myopia has been high globally and is exhibiting a rapid upward trend, with projections estimating it will reach 49.8% by 2050. Corneal refractive surgery has become a primary method for correcting myopia, demonstrating significant efficacy and favorable safety. However, studies indicate that overcorrection or undercorrection can occur following refractive surgery. Reports have shown that three months post-SMILE surgery, 20% of eyes had residual refractive errors ≥ 0.50 D, and 6% had errors ≥ 1.00 D. We hypothesize that this may be related to imprecise preoperative refraction, subsequently affecting postoperative visual quality.
Due to limitations in lens manufacturing precision, the widely used increment for sphere correction remains 0.25 D. However, this may prevent some patients from achieving their optimal corrected state. Studies have reported that 95% of individuals are sensitive to diopter changes below 0.25 D, and 44% can distinguish changes smaller than 0.125 D. Other research suggests that adjusting spherical power in 0.05 D increments yields better corrected visual acuity. Furthermore, scholars have reported that 0.05 D precision refraction can significantly improve the red-green balance test rate, enabling myopic patients to achieve better visual quality. Therefore, improving refraction precision could provide patients with superior visual outcomes.
Currently, the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) can perform objective and subjective refraction with 0.05 D increments for both sphere and cylinder correction, while also separately measuring higher-order aberrations (HOAs) and lower-order aberrations (LOAs). Given the scarcity of research on the outcomes of 0.05 D refraction for SMILE and FS-LASIK procedures, this study aims to evaluate visual acuity, aberrations, and refractive status in patients following SMILE and FS-LASIK surgery. The primary objective is to investigate whether preoperative 0.05 D precision refraction using the BWFOM can enhance postoperative visual quality for SMILE and FS-LASIK patients.
Read the detailed description
This study aims to optimize the surgical parameters of corneal refractive surgery (SMILE and FS-LASIK) by utilizing 0.05 D high-precision refraction achieved through a binocular wavefront aberrometer, thereby improving patients' postoperative visual outcomes. The prospective study design involves patients scheduled for corneal refractive surgery at our hospital.
The research consists of two parts:
Part One: Performing 0.05 D precision refraction on myopic patients using the binocular wavefront aberrometer.
Part Two: Applying the obtained refraction results (in increments of 0.05 D) for refractive correction in patients undergoing SMILE and FS-LASIK surgery.
Specific procedures include:
Screening eligible patients who voluntarily choose SMILE or FS-LASIK. Preoperatively inputting the patients' 0.05 D refraction data into the SMILE platform (VisuMax Precision 4.0 - VISULYZE system) or the FS-LASIK system (applying the manufacturer-provided nomogram for undercorrection).
Utilizing the system-recommended input values for correcting refractive errors during surgery.
Conducting postoperative follow-up examinations at 10 days, 1 month, 3 months, 6 months, and 1 year.
Evaluation metrics include:
- Primary Endpoint Indicators: Postoperative uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and aberrations. Proportion of patients achieving postoperative UCVA ≥ 0.8, ≥ 1.0, and ≥ 1.2. Proportion of patients with postoperative SE within ±0.50 D and ±1.0 D. Proportion of patients with postoperative astigmatism (cylinder) within ±0.50 D and ±1.0 D. Postoperative efficacy index and safety index.
- Safety Indicators:
Intraocular pressure (IOP). Anterior segment examination.
- Conditions
- Refractive Surgery
- Being tested
- Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)
- Keywords
- Corneal refractive surgery, SMILE, FS-LASIK, 0.05 D precision refraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)Device
The 0.05 D refraction group had their infusion rates precisely calibrated using 0.05 D refraction by the Binocular Wavefront Optometry Machine
| Study group | Role | What they receive |
|---|---|---|
| traditional group | No intervention | The traditional group had their infusion rates based on past experience. |
| 0.05 D refraction Group | Experimental | The 0.05 D refraction group had their infusion rates precisely calibrated using 0.05 D refraction by the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) Receives: Device: Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative spherical equivalent
It calculated as: SE = Sphere + ½ Cylinder
Measured: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Postoperative corrected distance visualacuity
Using the standard logarithmic visual acuity chart, with units in logMAR.
Measured: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Postoperative uncorrected distance visual acuity
Using the standard logarithmic visual acuity chart, with units in logMAR
Measured: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
spherical diopter
Spherical diopter (D) is the unit of measurement for the refractive (light-bending) power of a spherical lens (or the spherical component of a corrective lens) used to correct myopia (nearsightedness) or hyperopia (farsightedness).
Measured: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
cylinder diopter
The unit of measurement for the lens power required to correct astigmatism, representing the difference in refractive power between the steepest and flattest meridians (axes) of the eye or lens
Measured: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive SurgeryStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146828
- Sponsor's protocol ID
- 2025-K173
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery
- ClinicalTrials.gov ID
- NCT07146828
- Acronym / sponsor ID
- 2025-K173
- Conditions
- Refractive Surgery
- Keywords
- Corneal refractive surgery, SMILE, FS-LASIK, 0.05 D precision refraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
In recent years, the incidence of myopia has been high globally and is exhibiting a rapid upward trend, with projections estimating it will reach 49.8% by 2050. Corneal refractive surgery has become a primary method for correcting myopia, demonstrating significant efficacy and favorable safety. However, studies indicate that overcorrection or undercorrection can occur following refractive surgery. Reports have shown that three months post-SMILE surgery, 20% of eyes had residual refractive errors ≥ 0.50 D, and 6% had errors ≥ 1.00 D. We hypothesize that this may be related to imprecise preoperative refraction, subsequently affecting postoperative visual quality.
Due to limitations in lens manufacturing precision, the widely used increment for sphere correction remains 0.25 D. However, this may prevent some patients from achieving their optimal corrected state. Studies have reported that 95% of individuals are sensitive to diopter changes below 0.25 D, and 44% can distinguish changes smaller than 0.125 D. Other research suggests that adjusting spherical power in 0.05 D increments yields better corrected visual acuity. Furthermore, scholars have reported that 0.05 D precision refraction can significantly improve the red-green balance test rate, enabling myopic patients to achieve better visual quality. Therefore, improving refraction precision could provide patients with superior visual outcomes.
Currently, the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) can perform objective and subjective refraction with 0.05 D increments for both sphere and cylinder correction, while also separately measuring higher-order aberrations (HOAs) and lower-order aberrations (LOAs). Given the scarcity of research on the outcomes of 0.05 D refraction for SMILE and FS-LASIK procedures, this study aims to evaluate visual acuity, aberrations, and refractive status in patients following SMILE and FS-LASIK surgery. The primary objective is to investigate whether preoperative 0.05 D precision refraction using the BWFOM can enhance postoperative visual quality for SMILE and FS-LASIK patients.
Detailed description
This study aims to optimize the surgical parameters of corneal refractive surgery (SMILE and FS-LASIK) by utilizing 0.05 D high-precision refraction achieved through a binocular wavefront aberrometer, thereby improving patients' postoperative visual outcomes. The prospective study design involves patients scheduled for corneal refractive surgery at our hospital.
The research consists of two parts:
Part One: Performing 0.05 D precision refraction on myopic patients using the binocular wavefront aberrometer.
Part Two: Applying the obtained refraction results (in increments of 0.05 D) for refractive correction in patients undergoing SMILE and FS-LASIK surgery.
Specific procedures include:
Screening eligible patients who voluntarily choose SMILE or FS-LASIK. Preoperatively inputting the patients' 0.05 D refraction data into the SMILE platform (VisuMax Precision 4.0 - VISULYZE system) or the FS-LASIK system (applying the manufacturer-provided nomogram for undercorrection).
Utilizing the system-recommended input values for correcting refractive errors during surgery.
Conducting postoperative follow-up examinations at 10 days, 1 month, 3 months, 6 months, and 1 year.
Evaluation metrics include:
- Primary Endpoint Indicators: Postoperative uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and aberrations. Proportion of patients achieving postoperative UCVA ≥ 0.8, ≥ 1.0, and ≥ 1.2. Proportion of patients with postoperative SE within ±0.50 D and ±1.0 D. Proportion of patients with postoperative astigmatism (cylinder) within ±0.50 D and ±1.0 D. Postoperative efficacy index and safety index.
- Safety Indicators:
Intraocular pressure (IOP). Anterior segment examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional group | No intervention | –The traditional group had their infusion rates based on past experience. |
| 0.05 D refraction Group | Experimental | Device: Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)The 0.05 D refraction group had their infusion rates precisely calibrated using 0.05 D refraction by the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- Age: 18 to 40 years old;
- Optimal preoperative corrected visual acuity >= 4.8;
- More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- Patients who are willing to perform SMILE surgery
Key exclusion criteria (6 listed)
- Patients with history of eye surgery and trauma;
- Patients with keratoconus tendency;
- systemic connective tissue diseases and autoimmune diseases;
- Patients with high blood pressure, diabetes and heart disease history;
- Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
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 |
|---|---|---|
| Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China)The 0.05 D refraction group had their infusion rates precisely calibrated using 0.05 D refraction by the Binocular Wavefront Optometry Machine | Device | 0.05 D refraction Group |
Primary outcome
Postoperative spherical equivalent
Time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
It calculated as: SE = Sphere + ½ Cylinder
Postoperative corrected distance visualacuity
Time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Using the standard logarithmic visual acuity chart, with units in logMAR.
Postoperative uncorrected distance visual acuity
Time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Using the standard logarithmic visual acuity chart, with units in logMAR
spherical diopter
Time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
Spherical diopter (D) is the unit of measurement for the refractive (light-bending) power of a spherical lens (or the spherical component of a corrective lens) used to correct myopia (nearsightedness) or hyperopia (farsightedness).
cylinder diopter
Time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively
The unit of measurement for the lens power required to correct astigmatism, representing the difference in refractive power between the steepest and flattest meridians (axes) of the eye or lens
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) in people with Refractive Surgery, run by Affiliated Hospital of Nantong University at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ying Yu, MD (+86 159 9662 1616, yuying.2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative spherical equivalent (time frame: Preoperatively, and at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year postoperatively). The study lists 5 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 28 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.