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Personalized Addition lenses Clinical Trial (PACT) in Chinese children myopia

Personalized Addition lenses Clinical Trial (PACT) in Chinese children myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16007722
Enrollment
Unknown
Registered
2016-01-08
Start date
2014-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia

Interventions

1:0.00D addition
2:+2.0D addition
3:Personalized addition

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age: equal to or greater than 7 years and not older than 12 years; 2. Spherical refractive error of -0.75 to -4.00 D in each eye, as measured by cycloplegic autorefraction; 3. Astigmatism of not more than 1.50 D; 4. Anisometropia of not more than 1.00 D; 5. Best corrected visual acuity of equal or better than 0.05 LogMAR (>=0.9 as Snellen); 6. No strabismus by cover test at near and distance. The children will wear the best subjective correction as well as a +2.0 D add to make sure there is no tropia with the proposed intervention; 7. Heterophoria at 33 cm with subjective corrective lenses: esophoria or exophoria of not more than 10 pd measured with modified Thorington method; 8. No vertical phoria; 9. Have the ability to comply with the protocol to get the reliable study measurements; 10. Absence of ocular disease with full ophthalmic examination, such as retinal disease, cataract and ptosis. Good general health, without systemic or neurodevelopmental conditions. Without ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure; 11. No history of PALs or bifocal use and no prior use of contact lenses; 12. With myopia progression equal to or greater than 0.50 D in the preceding year.

Exclusion criteria

Exclusion criteria: 1. Age: less than 7 years old or greater than 12 years; 2. Spherical refractive error: less than -0.75 D or greater than -4.00 D in each eye, as measured by cycloplegic autorefraction; 3. Astigmatism of more than 1.50 D; 4. Anisometropia of more than 1.00 D; 5. Best corrected visual acuity of less than 0.05 LogMAR (< 0.9 as Snellen); 6. With strabismus by cover test at near or distance. The children will wear the best subjective correction as well as +2.0D Add to make sure whether there is tropia with the proposed intervention; 7. Exophoria at 33 cm with subjective corrective lenses greater than 10 pd measured with modified Thorington method; 8. With vertical phoria; 9. Without the ability to comply with the protocol to get the reliable study measurements; 10. Presence of any ocular disease that would influence refractive development, such as retinal disease, cataract and ptosis. Presence of systemic or neurodevelopmental conditions that may influence refractive development. Use of ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure; 11. Prior use of PALs or bifocal use or prior use of contact lenses; 12. Myopia progression less than 0.5 D in preceding year.

Design outcomes

Primary

MeasureTime frame
magnitude of the refractive error changes;

Secondary

MeasureTime frame
axial length;

Countries

China

Contacts

Public ContactChen Hao
chenhao823@mail.eye.ac.cn+86 13905778969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026