Investigation of the efficacy of the second generation Myopia Control Progressive Addition Lenses in the retardation of juvenile onset myopic progression in 6 to 12 year old children.

Carl Zeiss Vision0 个研究点目标入组 300 人开始时间: 2008年11月12日最近更新: 2020年1月13日

试验速览

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•1. Spherical equivalent refractive error (SER) of –0.50 to -4.50 D.
•2. Astigmatism of not more than -1.50 D.
•3. Anisometropia of not more than -1.50 D in spherical or cylindrical error.
•4. Visual acuity with best subjective correction of 0.00 LogMAR or better.
•5. Normal ocular health other than myopia.
•6. No prior use of bifocal or progressive lenses in the last 12 months.
•7. No rigid contact lenses or Bi-Focal contact lens experience and must be willing not to wear contact lenses.
•8. In satisfactory health.
•9. Willing and able to tolerate cycloplegia.
•10. Informed parental consent.

•1. Outside the age range 6 to 12 years at time of recruitment.
•2. Not willing to wear spectacles continuously.
•3. Not available for follow-up for at least 2 years.
•4. Absence of parental consent to the random assignment of their child to one of three spectacle lens groups.
•5. Any systemic condition which might affect refractive development or systemic diseases which may affect vision or refractive error.
•6. Previous use of contact lens/PALs or other treatment for myopia within the last 12 months.
•7. Defective binocular function.
•8. Amblyopia and or manifested squint.
•9. Vestibular disorders or motor imbalance.
•10. Any other conditions precluding adherence to the Protocol.

发起方

Carl Zeiss Vision