Visual QualityNCT06898164
The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia
An observational study of Visual Quality and Axial Length, run by yuhao shao at 1 site in China.
Trial summary
This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Quality, Axial Length, High Myopia
- What is being tested?
- This study does not involve any interventions
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Study population: A total of 113 high myopic patients (202 eyes) of Shanghai's Tenth People's Hospital were enroled in this prospective, non-randomized study conducted from July 2021 to September 2023.
Who may be able to join
- manifest refraction spherical equivalent refraction exceeding -6.00D;
- stable myopia for a duration of at least 2 years;
- corrected distance visual acuity of at least 20/25;
- annual myopic spherical equivalent increment less than - 0.50 D.
Who cannot join
- a history of moderate to severe dry eye as well as any ocular or systemic disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL).
Read the detailed description
The study enrolled 113 highly myopic patients (202 eyes) who underwent SMILE surgery at Shanghai's Tenth People's Hospital. Patients were classified into three groups based on the axial length before surgery: Group A (AL < 26 mm, 62 eyes), Group B (26 mm ≤ AL < 27 mm, 88 eyes), and Group C (AL ≥ 27 mm, 52 eyes). Preoperative and postoperative evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), equivalent spherical error(SE), and corneal high order aberration. Subjective visual quality was assessed using the Quality of Vision (QoV) questionnaire.
- Conditions
- Visual Quality, Axial Length, High Myopia
- Being tested
- This study does not involve any interventions
- Keywords
- Axial length, High myopia, SMILE, Higher-order aberration, visual quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not involve any interventionsOther
This study does not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| AL < 26 mm | high myopic patients with axial lengths < 26 mm Receives: Other: This study does not involve any interventions | |
| 26 mm ≤ AL < 27 mm | high myopic patients with 26 mm ≤ axial lengths < 27 mm Receives: Other: This study does not involve any interventions | |
| AL ≥ 27 mm | high myopic patients with axial lengths ≥ 27 mm Receives: Other: This study does not involve any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective visual quality
The quality of vision (QOV) questionnaire consists of (i) symptom frequency, (ii) severity, and (iii) bothersomeness for (a) glare, (b) halo, (c) starbursts, (d) hazy vision, (e) blurred vision, (f) distortion, (g) multiple images, (h) visual fluctuations, (i) difficulty focusing, and (j) difficulty judging distance or depth perception. Respondents use a scale of 0 to 3, where zero (0) denotes "none," one (1) "a little," two (2) "quite a bit," and three (3) "very much." Furthermore, on a scale from 0 to 10, patients were asked to provide Likert ratings for "daytime" and "nighttime" quality of vision (0 denoting the poorest vision, while 10 indicating the best vision)
Measured: 12 months
Secondary outcomes (1)
Refractive results
The uncorrected distance visual acuity (UDVA, logMAR), corrected distance visual acuity (CDVA, logMAR), subjective refraction (Diopter), and intraocular pressure (mmHg) were evaluated prior to and 1 year after SMILE.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jul 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual QualityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- yuhao shao
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Sponsor-investigator, yuhao shao, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898164
- Sponsor's protocol ID
- 2025AL
- Other IDs
- YJXYS-B-009, 202240131
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 27 Mar 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia
- ClinicalTrials.gov ID
- NCT06898164
- Acronym / sponsor ID
- 2025AL
- Conditions
- Visual Quality, Axial Length, High Myopia
- Keywords
- Axial length, High myopia, SMILE, Higher-order aberration, visual quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- yuhao shaoUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 27 Mar 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.
This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL).
Detailed description
The study enrolled 113 highly myopic patients (202 eyes) who underwent SMILE surgery at Shanghai's Tenth People's Hospital. Patients were classified into three groups based on the axial length before surgery: Group A (AL < 26 mm, 62 eyes), Group B (26 mm ≤ AL < 27 mm, 88 eyes), and Group C (AL ≥ 27 mm, 52 eyes). Preoperative and postoperative evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), equivalent spherical error(SE), and corneal high order aberration. Subjective visual quality was assessed using the Quality of Vision (QoV) questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL < 26 mm | – | Other: This study does not involve any interventionshigh myopic patients with axial lengths < 26 mm |
| 26 mm ≤ AL < 27 mm | – | Other: This study does not involve any interventionshigh myopic patients with 26 mm ≤ axial lengths < 27 mm |
| AL ≥ 27 mm | – | Other: This study does not involve any interventionshigh myopic patients with axial lengths ≥ 27 mm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 113 high myopic patients (202 eyes) of Shanghai's Tenth People's Hospital were enroled in this prospective, non-randomized study conducted from July 2021 to September 2023.
Key inclusion criteria (4 listed)
- manifest refraction spherical equivalent refraction exceeding -6.00D;
- stable myopia for a duration of at least 2 years;
- corrected distance visual acuity of at least 20/25;
- annual myopic spherical equivalent increment less than - 0.50 D.
Key exclusion criteria (1 listed)
- a history of moderate to severe dry eye as well as any ocular or systemic disease.
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 |
|---|---|---|
| This study does not involve any interventionsThis study does not involve any interventions | Other | 26 mm ≤ AL < 27 mm, AL < 26 mm, AL ≥ 27 mm |
Primary outcome
Subjective visual quality
Time frame: 12 months
The quality of vision (QOV) questionnaire consists of (i) symptom frequency, (ii) severity, and (iii) bothersomeness for (a) glare, (b) halo, (c) starbursts, (d) hazy vision, (e) blurred vision, (f) distortion, (g) multiple images, (h) visual fluctuations, (i) difficulty focusing, and (j) difficulty judging distance or depth perception. Respondents use a scale of 0 to 3, where zero (0) denotes "none," one (1) "a little," two (2) "quite a bit," and three (3) "very much." Furthermore, on a scale from 0 to 10, patients were asked to provide Likert ratings for "daytime" and "nighttime" quality of vision (0 denoting the poorest vision, while 10 indicating the best vision)
1 secondary outcome
Refractive results
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Quality and Axial Length, run by yuhao shao 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective visual quality (time frame: 12 months). 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 27 Mar 2025.