To determine the rate of refractive error change in children wearing multifocal soft contact lens as compared to those wearing single vision soft contact lenses
- Conditions
- MyopiaEye - Normal eye development and function
- Registration Number
- ACTRN12611001148965
- Lead Sponsor
- Brien Holden Vision Institute (at the time of the trial known as Institute for Eye Research)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
Binocular vision problems
strabismus
amblyopia
External ocular problems that may impact lens fit (i.e. lid ptosis, chalazia, swollen lids).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate of myopia progression, as assessed by cycloplegic auto refraction in children wearing multifocal soft contact lenses as compared to children wearing single vision soft contact lenses over a three year period.[Every 3 months for a total duration of 3 years.]
- Secondary Outcome Measures
Name Time Method To determine the fitting characteristics of, and ocular response to, soft contact lenses worn on a DW basis by children aged 8 to 14 years. This will be done by clinical assessments such as Slit lamp biomicroscopy. This will be used to assess the following variables and rated using the IER Grading scales.<br>Lens assessment<br>Lens wetting<br>Lens surface deposition<br>Lens fitting<br>Ocular redness-bulbar and limbal<br>Palpebral ocular redness and roughness (in conjunction with lid eversion)<br>Corneal and conjunctival staining (in conjunction with fluorescein and a Wratten 12 filter)[Every 3 months for a total duration of 3 years.]