Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over a 7 year period.

Brien Holden Vision Institute0 sites14 target enrollmentAugust 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

August 13, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Brien Holden Vision Institute

•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;

•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;