None listed
Conditions
Brief summary
Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over 4 years
Interventions
Participants are wearing multifocal contact lenses that correct their myopia on a daily wear basis for a minimum of 5 days a week and at least 6 hours per day over a 4 year period.
This trial is a direct follow up to trial IERP2007-009 as it was offered to those that completed IERP2007-009. The aim of this trial was to evaluate the rate of myopia progression, as assessed by cycloplegic autorefraction in children and adolescents wearing multifocal soft contact lenses over a 4-year period followin
Participants are wearing multifocal contact lenses that correct their myopia on a daily wear basis for a minimum of 5 days a week and at least 6 hours per day over a 4 year period. This trial is a direct follow up to trial IERP2007-009 as it was offered to those that completed IERP2007-009. The aim of this trial was to evaluate the rate of myopia progression, as assessed by cycloplegic autorefraction in children and adolescents wearing multifocal soft contact lenses over a 4-year period following participation in IERP2007-009.The main objective of IERP2007-009 was to compare the rate of myopia progression, as assessed by cycloplegic autorefraction in children wearing multifocal soft contact lenses as compared to children wearing single vision soft contact lenses over a 3-year period.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
11 Years to 17 Years
Healthy volunteers
Yes
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
Outcome results
None listed