Assessment of myopia progression rates in children and adolescents

Not Applicable

• Conditions: Myopia; Cycloplegic refraction; Ocular axial length; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12612000849897
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

have successfully completed IER2008-001
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, must be accompanied by their parent(s)/legal guardian when signing the informed consent form;
be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses;
have vision correctable to at least 6/9 (20/30) or better in each eye with contact lenses;

Exclusion Criteria

an ocular condition that may preclude safe wearing of contact lenses;
an active corneal infection or any active ocular disease that would affect wearing of contact lenses;
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 or the performance of the lenses;
had eye surgery within 12 weeks immediately prior to enrolment for this trial;
undergone corneal refractive surgery;
any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
contraindications to contact lens wear;
had orthokeratology;
binocular vision problems such as strabismus or amblyopia;
any participant from anti myopia studies who has any unresolved ocular problem
currently enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To monitor the rate of progression of myopia, as assessed by cycloplegic auto-refraction (using Nidek TONOREF 2) and axial length change (using Zeiss IOL master)[At baseline, 6 month, 12month, 18month, 24month, 30month and 36month]

Secondary Outcome Measures

Name	Time	Method
To determine the characteristics of the peripheral refraction profiles (using Shin Nippon N-Vision K5001 Autorefractor and EyeMapper)over time in children & adolescents with and without multifocal contact lenses[At baseline, 12month, 24month and 36month]