None listed
Conditions
Brief summary
This randomised controlled trial aims to evaluate the efficacy of Extended Depth of Focus (EDOF) contact lenses in slowing myopia progression in Malaysian children. One hundred twenty participants aged 7 to 15 years with myopia between -0.50 dioptres and -8.00 dioptres will be randomly assigned to wear either EDOF Mid lenses, MiSight lenses, or SEED 1dayPure single vision lenses for two years. After one year, participants in the single vision lens group will be refitted with EDOF Mid in one eye and MiSight in the fellow eye to compare contralateral efficacy. Primary outcomes are change in spherical equivalent refractive error and change in axial length measured at baseline, 6, 12, 18, and 24 months. Secondary outcomes include choroidal thickness, accommodation, contrast sensitivity, ocular comfort, tear film parameters, lens fit, and binocular vision. This study will provide the first evidence on the effectiveness of EDOF contact lenses for myopia control in a Malaysian paediatric population.
Interventions
Description of Intervention:
• Arm 1 (EDOF Mid): Extended Depth of Focus (EDOF) contact lenses (SEED, Japan). Daily disposable, worn bilaterally for a minimum of 8 hours/day, 5 days/week. Material: 2-HEMA, negative monomer, positive monomer, MMA, EGDMA. Water content: 58%. BOZR: 8.4 mm. Diameter: 14.2 mm. Powers: -0.50D to -8.00D. Duration: 24 months.
• Arm 2 (MiSight): MiSight contact lenses (CooperVision). Daily disposable, worn bilaterally for a minimum of 8 hours/day, 5 days/week. Material:
Description of Intervention: • Arm 1 (EDOF Mid): Extended Depth of Focus (EDOF) contact lenses (SEED, Japan). Daily disposable, worn bilaterally for a minimum of 8 hours/day, 5 days/week. Material: 2-HEMA, negative monomer, positive monomer, MMA, EGDMA. Water content: 58%. BOZR: 8.4 mm. Diameter: 14.2 mm. Powers: -0.50D to -8.00D. Duration: 24 months. • Arm 2 (MiSight): MiSight contact lenses (CooperVision). Daily disposable, worn bilaterally for a minimum of 8 hours/day, 5 days/week. Material: Omafilcon A, 2-HEMA and 2-MPC cross linked with EGDMA. Water content: 60%. BOZR: 8.7 mm. Diameter: 14.2 mm. Powers: -0.50D to -10.00D. Duration: 24 months. *Arm 1 and Arm 2 do not cross over, they wear the same lens for 24 months. Adherence, Fidelity, and Logistics (New Details): • Visit Schedule: For all arms, there is a 2-hour consultation at Baseline, 1-hour consultations at 1 week, followed by a 2-hour consultation at 1 month, 6 months, 12 months, 18 months, and 24 months. • Administration: A qualified Optometrist will perform all clinical assessments and initial lens fittings. The daily application and removal of lenses will be performed by the participant under parental supervision. • Lens Provision: A six-month supply of trial lenses will be supplied to parents and children at the baseline visit and each subsequent 6-month follow-up visit.
Sponsors
International Islamic University Malaysia (IIUM)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1) Children aged 7 to 15 years inclusive. 2) Spherical equivalent refractive error between -0.50 dioptres and -8.00 dioptres inclusive. 3) Astigmatism less than -1.00 dioptres cylinder. 4) Monocular and binocular visual acuity of at least 6/6 (logMAR 0.0) or better with best correction. 5) Able to be satisfactorily fitted with the study contact lens types. 6) Willing to comply with lens wear schedule: minimum 8 hours per day, at least 5 days per week. 7) Parent or guardian willing and able to provide written informed consent. 8) Child willing and able to provide written assent. 9) Parent or guardian and child willing and able to comply with all study procedures and follow-up visits. 10) Agreement not to participate in other clinical research for the duration of this study.
Exclusion criteria
1) Monocular contact lens wear (wears contact lens in only one eye). 2) Previous participation in any myopia control research or treatment. 3) Ocular disorder(s) that normally contraindicate contact lens wear (e.g. keratoconus, corneal dystrophy, recurrent corneal erosion, dry eye disease). 4) Systemic disorder(s) that normally contraindicate contact lens wear (e.g. immunosuppressive disease, HIV, history of anaphylaxis or severe allergic reaction). 5) Current use of any topical ocular medication (e.g. eye drops, ointments). 6) Previous ocular surgery of any type (e.g. refractive surgery, cataract surgery). 7) Corneal distortion or keratoconus. 8) Currently on immunosuppressive medication. 9) Any ocular abnormality which, in the opinion of the investigator, contraindicates contact lens wear. 10) Any infectious disease which, in the opinion of the investigator, contraindicates contact lens wear or poses a risk to study personnel. 11) Participation in any other contact lens or care solution clinical trial or research prior to starting this study. 12) Miss two or more consecutive scheduled visits during the study (discontinuation criterion).
Outcome results
None listed