Myopia control lens efficacy trial

Completed

• Conditions: Juvenile onset myopia; Eye - Normal eye development and function

• Registration Number: ACTRN12608000566336
• Lead Sponsor: Carl Zeiss Vision

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified