NCT07142915

Brief Summary

This study aims to assess the efficacy of light-blocking lenses in facilitating emmetropization in children with hyperopia and to explore their influence on various aspects of visual function.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Aug 2025Jun 2027

First Submitted

Initial submission to the registry

August 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

August 18, 2025

Last Update Submit

August 25, 2025

Conditions

Hyperopia

Keywords

hyperopialight-blocking lensesemmetropizationvisual function

Outcome Measures

Primary Outcomes (1)

  • Axial length

    measured by optical biometer

    At baseline, 6 months, and 12 months

Secondary Outcomes (8)

  • Refractive error

    At baseline, 6 months, and 12 months

  • Best-corrected visual acuity

    At baseline, 6 months, and 12 months

  • Intraocular pressure

    At baseline, 6 months, and 12 months

  • Angle of deviation

    At baseline, 6 months, and 12 months

  • Contrast sensitivity

    At baseline, 6 months, and 12 months

  • +3 more secondary outcomes

Other Outcomes (3)

  • Height

    At baseline, 6 months, and 12 months

  • Weight

    At baseline, 6 months, and 12 months

  • Choroidal thickness (optional)

    At baseline, 6 months, and 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Subjects will be instructed to wear light-blocking lenses full-time for 12 months. Scheduled follow-up examinations will be conducted at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Replacement of the lenses will be arranged if a refractive change greater than 0.50 diopters is observed, or in cases of severe lens damage.

Other: light-blocking lenses

Control Group

PLACEBO COMPARATOR

Subjects will be instructed to wear single-vision lenses full-time for 12 months. Scheduled follow-up examinations will be conducted at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Replacement of the lenses will be arranged if a refractive change greater than 0.50 diopters is observed, or in cases of severe lens damage.

Other: single-vision lenses

Interventions

light-blocking lensesOTHER

Subjects will be instructed to wear light-blocking lenses full-time for 12 months.

Intervention Group
single-vision lensesOTHER

Subjects will be instructed to wear single-vision lenses full-time for 12 months.

Control Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6 years or older and 12 years or younger;
  • Spherical refractive error in both eyes between +3.0 D and +7.5 D, cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power less than 1.5 D and in cylindrical power no greater than 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Jinrong Li, MD PhD

CONTACT

86-020-87330351lijingr3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 27, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)