Follow-up study on participants who participated in Institute for Eye Research Protocol (IERP2007-009) - ‘Myopia progression in children: multifocal soft contact lenses versus single vision soft contact lenses’
- Conditions
- Cycloplegic refraction and ocular axial length.MyopiaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12612000105842
- Lead Sponsor
- Brien Holden Vision Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 26
have successfully enrolled in study IERP2007-009
be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent (or their parent(s)/legal guardian);
if under 18 years of age, be accompanied by their parent(s)/legal guardian when signing the informed consent form;
be willing to comply with the clinical trial visit schedule as directed by the investigator;
have ocular health findings considered to be normal”;
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude the use of diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine).
a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology;
had eye surgery within 12 weeks immediately prior to enrolment for this trial;
known allergy or intolerance to ingredients in any of the clinical trial products
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the rate of myopia progression, as assessed by cycloplegic autorefraction, in children and adolescents who participated in IERP2007-009.[This study involves only 1 visit];To determine the characteristics of the peripheral refraction profiles in children and adolescents following participation in IERP2007-009. Peripheral refraction will be measured using a Shin Nippon open-field autorefractor or eyemapper instrument.[This study involves only 1 visit]
- Secondary Outcome Measures
Name Time Method To obtain a history of the refractive correction chosen by the participants since they completed IERP2007-009 and their lifestyle variables. This outcome will be assessed using questionnaires.[This study involves only 1 visit]