AnisometropiaNCT07142928
Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children
A study testing light-blocking lenses and single-vision lenses in people with Anisometropia and Hyperopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anisometropia, Hyperopia
- What is being tested?
- light-blocking lenses and single-vision lenses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Jinrong Li, MD PhD, 86-020-87330351, lijingr3@mail.sysu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in 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.
- Conditions
- Anisometropia, Hyperopia
- Being tested
- light-blocking lenses, single-vision lenses
- Keywords
- Anisometropia, Hyperopia, light-blocking lenses, emmetropization
- Medical subject headings
- Anisometropia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light-blocking lensesOther
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 lensesOther
Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Other: light-blocking lenses |
| Control group | Placebo comparator | 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. Receives: Other: single-vision lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
measured by optical biometer
Measured: At baseline, 6 months, and 12 months
Secondary outcomes (8)
Refractive error
measured by cycloplegic refraction
Measured: At baseline, 6 months, and 12 months
Best-corrected visual acuity
measured by visual acuity chart
Measured: At baseline, 6 months, and 12 months
Intraocular pressure
measured by non-contact tonometer
Measured: At baseline, 6 months, and 12 months
Angle of deviation
measured by alternate cover test with prism
Measured: At baseline, 6 months, and 12 months
Contrast sensitivity
measured by quick contrast sensitivity function test
Measured: At baseline, 6 months, and 12 months
Stereopsis
measured by stereotest booklet
Measured: At baseline, 6 months, and 12 months
Accommodative function
measured by phoropter
Measured: At baseline, 6 months, and 12 months
Intervention questionnaire
measured by questionnaire
Measured: At baseline, 6 months, and 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 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnisometropiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingrong Li, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142928
- Sponsor's protocol ID
- 2025KYPJ092
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 27 Aug 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in Hyperopic Anisometropic Children
- ClinicalTrials.gov ID
- NCT07142928
- Acronym / sponsor ID
- 2025KYPJ092
- Conditions
- Anisometropia, Hyperopia
- Keywords
- Anisometropia, Hyperopia, light-blocking lenses, emmetropization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: light-blocking lensesThe 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 |
| Control group | Placebo comparator | Other: single-vision lensesBoth 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
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 |
|---|---|---|
| light-blocking lensesThe 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 | Other | Intervention Group |
| single-vision lensesBoth eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months. | Other | Control group |
Primary outcome
Axial length
Time frame: At baseline, 6 months, and 12 months
measured by optical biometer
8 secondary outcomes
Refractive error
Time frame: At baseline, 6 months, and 12 months
Best-corrected visual acuity
Time frame: At baseline, 6 months, and 12 months
Intraocular pressure
Time frame: At baseline, 6 months, and 12 months
Angle of deviation
Time frame: At baseline, 6 months, and 12 months
Contrast sensitivity
Time frame: At baseline, 6 months, and 12 months
Stereopsis
Time frame: At baseline, 6 months, and 12 months
Accommodative function
Time frame: At baseline, 6 months, and 12 months
Intervention questionnaire
Time frame: At baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light-blocking lenses and single-vision lenses in people with Anisometropia and Hyperopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Aug 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinrong Li, MD PhD (86-020-87330351, lijingr3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: At baseline, 6 months, and 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 Aug 2025.