Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over 4 years.

Not Applicable

Completed

• Conditions: Myopia; Eye - Normal eye development and function

• Registration Number: ACTRN12611001141932
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

have successfully participated 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 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

-pre-existing ocular irritation that would preclude contact lens fitting;
-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 estimate the rate of myopia progression by cycloplegic autorefraction.[Every 6 months for total duration of 4 years]

Secondary Outcome Measures

Name	Time	Method
To determine the characteristics of the peripheral refraction profile with and without multifocal contact lenses[Every 6 months for total duration of 4 years]