ClinicalTrials.gg
Not yet recruitingNCT07142928Updated Aug 27, 2025

Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

An interventional study of light-blocking lenses and single-vision lenses in Anisometropia and Hyperopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

To evaluate the effectiveness of light-blocking lenses in promoting emmetropization and reducing anisometropia in children with hyperopic anisometropia, and to assess the impact of light-intercepting lenses on visual function in this population.

02

Conditions studied

  • Anisometropia
  • Hyperopia

Keywords

  • Anisometropia
  • Hyperopia
  • light-blocking lenses
  • emmetropization
03

In context

Anisometropia

31 studies on the registry are indexed under Anisometropia; 10 are open to participants now.

This study's planned enrollment of 90 is above the median of 58 across 24 interventional studies indexed under Anisometropia.

Browse Anisometropia studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Aged 6 years or older and 12 years or younger;
  • The more hyperopic eye has a spherical refractive error between +3.0 D and +7.5 D; the less hyperopic eye has a spherical refractive error of at least +2.0 D; cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power >=1.5 D and in cylindrical power \<=1.0 D;
  • Best-corrected visual acuity of 0.0 logMAR or better in both eyes;
  • Ocular deviation with spectacles less than 10 prism diopters;
  • Has been wearing standard single-vision spectacles regularly for more than six months;
  • In good general health, capable of receiving the study intervention, and willing to comply with the study protocol;
  • Written obtained from both the parent/guardian and the child, with agreement to comply with all study procedures and maintain follow-up availability throughout the study period;

Exclusion criteria

Exclusion Criteria:

  • History of ocular trauma or eye surgery;
  • Presence of pathological abnormalities on anterior or posterior segment examination, or a history of organic ocular diseases such as cataract, glaucoma, corneal disease, or fundus disorders;
  • Intraocular pressure greater than 21 mmHg;
  • Presence of systemic diseases or other conditions deemed unsuitable for study participation;
  • Any other condition deemed inappropriate for participation in the clinical trial by the investigator;
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    The eye with higher hyperopia will be fitted with light-blocking lenses for full-time wear, while the fellow eye with lower hyperopia will be fitted with conventional single-vision lenses for full-time wear, over 12 months. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters occurs or if the lenses become severely damaged

    Other: light-blocking lenses

  • Placebo comparator
    Control group

    Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12-months. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters is detected or if the lenses become severely damaged.

    Other: single-vision lenses

Interventions

  • Otherlight-blocking lenses

    The eye with higher hyperopia will be fitted with light-blocking lenses for full-time wear, while the fellow eye with lower hyperopia will be fitted with conventional single-vision lenses for full-time wear, over 12 months

  • Othersingle-vision lenses

    Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.

06

What researchers measure

Primary outcomes

  1. Axial length

    measured by optical biometer

    Time frame: At baseline, 6 months, and 12 months

Secondary outcomes

  1. Refractive error

    measured by cycloplegic refraction

    Time frame: At baseline, 6 months, and 12 months

  2. Best-corrected visual acuity

    measured by visual acuity chart

    Time frame: At baseline, 6 months, and 12 months

  3. Intraocular pressure

    measured by non-contact tonometer

    Time frame: At baseline, 6 months, and 12 months

  4. Angle of deviation

    measured by alternate cover test with prism

    Time frame: At baseline, 6 months, and 12 months

  5. Contrast sensitivity

    measured by quick contrast sensitivity function test

    Time frame: At baseline, 6 months, and 12 months

  6. Stereopsis

    measured by stereotest booklet

    Time frame: At baseline, 6 months, and 12 months

  7. Accommodative function

    measured by phoropter

    Time frame: At baseline, 6 months, and 12 months

  8. Intervention questionnaire

    measured by questionnaire

    Time frame: At baseline, 6 months, and 12 months

Other outcomes

  1. Height

    measured by ruler

    Time frame: At baseline, 6 months, and 12 months

  2. Weight

    measured by weighing scale

    Time frame: At baseline, 6 months, and 12 months

  3. Choroidal thickness (optional)

    measured by OCT, optional

    Time frame: At baseline, 6 months, and 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07142928
Responsible party
Jingrong Li (Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Aug 27, 2025
Start date
Aug 25, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 27, 2025

Study contacts

Jinrong Li, MD PhD
Contact
lijingr3@mail.sysu.edu.cn
86-020-87330351

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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