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NCT Number: NCT07142928

Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent 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

  • 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;

Treatment and study plan

light-blocking lenses

Other

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

single-vision lenses

Other

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

Primary outcomes

  1. Axial length

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

    measured by optical biometer

Secondary outcomes

  1. Refractive error

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

    measured by cycloplegic refraction

  2. Best-corrected visual acuity

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

    measured by visual acuity chart

  3. Intraocular pressure

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

    measured by non-contact tonometer

  4. Angle of deviation

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

    measured by alternate cover test with prism

  5. Contrast sensitivity

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

    measured by quick contrast sensitivity function test

  6. Stereopsis

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

    measured by stereotest booklet

  7. Accommodative function

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

    measured by phoropter

  8. Intervention questionnaire

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

    measured by questionnaire

Other outcomes

  1. Height

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

    measured by ruler

  2. Weight

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

    measured by weighing scale

  3. Choroidal thickness (optional)

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

    measured by OCT, optional

Study contacts

Contact information is provided by the study sponsor or research team.

Jinrong Li, MD PhD

CONTACT

[email protected]

86-020-87330351

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in Hyperopic Anisometropic Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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