None listed
Conditions
Brief summary
A sample of 40 subjects were equally divided into the test group (multifocal) and control group (single vision). Participants wore these lenses on a daily wear basis over a 3 year period.
Interventions
Participants were given either multifocal or standard single vision soft contact lenses to wear on a daily wear basis for a minimum 10 hours a day over a 3 year period. Multifocal lenses have different powers across the lens surface whereas single vision lenses only have one power.
Sponsors
Brien Holden Vision Institute (at the time of the trial known as Institute for Eye Research)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 8 to 14 years Parents / guardians must sign the subject informed consent (Appendix 1) Cycloplegic autorefraction - sphere -0.50 D to -4.00 D, cylinder 0 to -0.75 D Best corrected visual acuity 6/9 or better; On examination, eyes are required to have clinical findings considered to be “normal” and which would not prevent a subject from safely wearing contact lenses. These include: stable and distortion-free keratometric readings; no active corneal infection, inflammation or infection of the anterior chamber of the eye or any eye disease, injury or abnormality of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses; no previous ocular surgery; no severe insufficiency of lacrimal secretion (dry eyes); no evidence of corneal hypoesthesia (reduced corneal sensitivity); no systemic disease or use of medications that may affect the eye or produce an adverse response by the wearing of contact lenses.
Exclusion criteria
Binocular vision problems strabismus amblyopia External ocular problems that may impact lens fit (i.e. lid ptosis, chalazia, swollen lids).
Outcome results
None listed