An interventional study of Dual-Effect Myopia Control Spectacle Lenses and Nikon Kongyoudian 2.0 Spectacle Lenses in Myopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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Among 24 studies in Myopia by Zhongshan Ophthalmic Center, Sun Yat-sen University — 12 open to participants now, 14 under way, none of them phase 3. Myopia · Zhongshan Ophthalmic Center, Sun Yat-sen University.
Among the 24 studies in Myopia by Zhongshan Ophthalmic Center, Sun Yat-sen University, this one is the 9th largest by planned enrollment of the 17 interventional ones that give a count, is one of 5 that started in 2026, is one of 17 with no phase, reaches primary completion later than 12 of the 13 other live ones, and was the 24th registered.
1,160 studies on the registry are indexed under Myopia; 225 are open to participants now.
Browse Myopia studies →12 of the 24 studies in Myopia by Zhongshan Ophthalmic Center, Sun Yat-sen University are open now, in 1 country. Recruiting first, the newest first:
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 6–18 · Healthy volunteers
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18–40
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18–40
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 3–18 · Healthy volunteers
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18–40
By country, each count listing its studies:
Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.
This study: 8 Years to 13 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 194 is above the median of 78 across 923 interventional studies indexed under Myopia.
Median enrollment 194 across the 17 interventional studies, 1,000 across the 7 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 165 studies on the registry; 81 are open to participants now.
4 of the studies in Myopia by Zhongshan Ophthalmic Center, Sun Yat-sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06667037Zhongshan Ophthalmic Center, Sun Yat-sen UniversityOrthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control | 2026-12-31 |
| NCT07512102Zhongshan Ophthalmic Center, Sun Yat-sen UniversityComparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial | 2027-05-30 |
| NCT07512115Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery? | 2027-05-30 |
| NCT07696468Zhongshan Ophthalmic Center, Sun Yat-sen UniversityComparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 24 studies in Myopia by Zhongshan Ophthalmic Center, Sun Yat-sen University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate the efficacy and safety of dual-effect myopia control spectacle lenses in slowing myopia progression compared with Nikon MyoEase 2.0 lenses in children aged 8-13 years.
This is a single-center, randomized, open-label, parallel-group, noninferiority clinical trial. A total of 194 children with myopia will be randomly assigned in a 1:1 ratio to wear either dual-effect myopia control spectacle lenses or Nikon MyoEase 2.0 lenses for 12 months.
The primary outcome is the change in cycloplegic objective spherical equivalent refraction from baseline to 12 months. Secondary outcomes include changes in refractive error, ocular biometric parameters, visual acuity, binocular visual function, and visual questionnaire scores. Safety will also be assessed throughout the study.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will wear dual-effect myopia control spectacle lenses for 12 months, with a recommended daily wearing time of at least 12 hours.
Device: Dual-Effect Myopia Control Spectacle Lenses
Participants in this group will wear Nikon Kongyoudian 2.0 spectacle lenses for 12 months, following the same wearing instructions as the experimental group.
Device: Nikon Kongyoudian 2.0 Spectacle Lenses
Dual-effect myopia control spectacle lenses manufactured by Jiangsu Kangmeida Optical Co., Ltd. Participants will be advised to wear the spectacles for at least 12 hours per day for 12 months.
Nikon Kongyoudian 2.0 spectacle lenses manufactured by Nikon Optical Co., Ltd. The lenses will be used in the same manner as the investigational lenses for 12 months.
Change in Cycloplegic Spherical Equivalent Refraction at 12 Months
Change in spherical equivalent refraction (SER) from baseline to 12 months, measured by objective autorefraction under cycloplegia. SER is calculated as sphere power plus half the cylinder power, expressed in diopters (D).
Time frame: Baseline and 12 months (±30 days)
Change in Axial Length
Change in axial length from baseline, measured before cycloplegia using optical biometry.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Cycloplegic Spherical Equivalent Refraction at 6 Months
Change in spherical equivalent refraction (SER) from baseline to 6 months, measured by objective autorefraction under cycloplegia, expressed in diopters (D).
Time frame: Baseline and 6 months (±30 days)
Visual Acuity With Study Spectacles
Visual acuity measured while wearing the assigned study spectacles.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Corneal Curvature
Change in corneal curvature from baseline, measured before cycloplegia using optical biometry.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Anterior Chamber Depth
Change in anterior chamber depth from baseline, measured before cycloplegia using optical biometry.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Lens Thickness
Change in crystalline lens thickness from baseline, measured before cycloplegia using optical biometry.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Subjective Refraction
Change in subjective refraction from baseline, assessed before cycloplegia.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Best-Corrected Visual Acuity
Best-corrected visual acuity assessed using an ETDRS logMAR E chart.
Time frame: 6 months (±30 days) and 12 months (±30 days)
Change in Binocular Visual Function
Change in binocular visual function from baseline, assessed at follow-up visits.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
Visual Questionnaire Score
Visual assessment using the Chinese version of the PRER2 questionnaire.
Time frame: 6 months (±30 days) and 12 months (±30 days)
Incidence of Adverse Events and Serious Adverse Events
Occurrence of symptoms, signs, complications, adverse events, and serious adverse events related to the study products or procedures.
Time frame: Throughout the 12-month study period
Intraocular Pressure
Intraocular pressure measured using non-contact tonometry, expressed in mmHg.
Time frame: 6 months (±30 days), and 12 months (±30 days)
Fundus Examination Grade
Fundus findings assessed and graded according to the study protocol.
Time frame: 6 months (±30 days), and 12 months (±30 days)
Spectacle Frame Position Assessment
Assessment of spectacle frame positioning and lens condition according to the study protocol.
Time frame: Baseline, 6 months (±30 days), and 12 months (±30 days)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with external researchers.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Zhongshan Ophthalmic Center, Sun Yat-sen University →