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Myopia control with progressive spectacle lenses trial

Not Applicable
Completed
Conditions
Juvenile onset myopia
Eye - Diseases / disorders of the eye
Registration Number
ACTRN12611000582954
Lead Sponsor
Carl Zeiss Vision
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
165
Inclusion Criteria

1) Spherical equivalent refractive error (SER) of –1.00 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) Have best corrected visual acuity of at least 6/9 (20/30) in each eye.
5) Normal ocular health other than myopia.
6) No prior use of bifocal or progressive lenses in the last 12 months.
7) No RPG contact lens experience and must be willing not to wear contact lenses.
8) In satisfactory health.
9) Willing and able to tolerate cycloplegia (no previous adverse reaction to cycloplegics).
10) Informed parental consent.

Exclusion Criteria

1) Any systemic condition which might affect refractive development or systemic diseases which may affect vision or refractive error.
2) Previous use of contact lens/PALs or other treatment for myopia within the last 12 months.
3) Defective binocular function.
4) Amblyopia and or manifested squint.
5) Vestibular disorders or motor imbalance.
6) Any other conditions precluding adherence to the Protocol.
7) Have best corrected visual acuity worse than 6/9 (20/30) in each eye.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression in sphere equivalent refractive error from cycloplegic autorefraction using the Grand Seiko WR-5100K open field auto-refractor.[At 6, 12, 18 & 24 months.]
Secondary Outcome Measures
NameTimeMethod
Progression in axial length of the eyeball. This will be measured using a Sonomed A Scan or Tomey A Scan ultrasound measuring device.[At 6, 12, 18 & 24 months.]
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