None listed
Conditions
Brief summary
The Brien Holden Vision Institute (previously known as the Institute for Eye Research) conducted a clinical trial to test commercially-available multifocal contact lenses for their potential to control the progression of myopia in children(IERP2007-009, ACTRN12611001148965; http://www.anzctr.org.au/trial_view.aspx?ID=347659 ). The trial was completed in 2008. Approximately half of the 40 children who participated in trial IERP2007-009 were enrolled in a subsequent myopia control trial at the Brien Holden Vision Institute (IER2008-001, ACTRN12611001141932; http://www.anzctr.org.au/trial_view.aspx?ID=347655 ) in which all participants wore the test product of trial IERP2007-009. Both IERP 2007-009 and IER2008-001 have provided valuable information on the efficacy of the multifocal contact lenses in controlling the rate of progression of myopia. This research is based on the hypothesis that the peripheral retina plays a role in controlling the refractive development of the eye as shown in animal experiments (Smith et al. 2007). In this study, the participants will continue to wear the commercially available multifocal contact lenses used in the previous two trials (IERP2007-009 and IER2008-001) to see whether the efficacy of controlling myopia with this lenses will still remain true for a longer period of time.
Interventions
Cycloplegic refractive error will be measured both objectively (using Nidek Tonoref 2) and subjectively(using phoropter, subjective measure will be based on the participant's input and clinician's judgement); ocular axial length will be measured using a Zeiss IOL master (3 readings per eye will be taken, the average of these reading will be recorded, the entire procedure will take less than 5 minutes). Cycloplegia will be achieved using diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine
Cycloplegic refractive error will be measured both objectively (using Nidek Tonoref 2) and subjectively(using phoropter, subjective measure will be based on the participant's input and clinician's judgement); ocular axial length will be measured using a Zeiss IOL master (3 readings per eye will be taken, the average of these reading will be recorded, the entire procedure will take less than 5 minutes). Cycloplegia will be achieved using diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine). All participants in this study need to have completed the IERP2007-009 study 'Myopia Progression in Children: Multifocal Soft Contact Lenses Versus Single Vision Soft Contact Lenses' (http://www.anzctr.org.au/trial_view.aspx?ID=347659) and IER2008-001 study 'Assessment of effect of multifocal contact lenses on myopia progression rates in children and adolescents' (http://www.anzctr.org.au/trial_view.aspx?ID=347655)
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 23 Years
Healthy volunteers
Yes
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
Outcome results
None listed