To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.
Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months. The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 6 months then visits every 6 months after. All procedures performed at these visits are standard, non invasive clinical tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
441
Ocufilcon D, 55% water
Ocufilcon D, 55% water
Omafilcon A (60% water)
Wenzhou Medical University Eye Hospital
Wenzhou, Lucheng District, China
Tianjin Medical University
Tianjin, Wuqing District, China
Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, China
LV Prasad Eye Institute
Hyderabad, Telangana, India
Axial Length
Difference in change from baseline in axial length between test and control contact lenses.
Time frame: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Cycloplegic spherical equivalent autorefraction
Difference in change from baseline in spherical equivalent autorefraction between test and control contact lenses.
Time frame: Baseline, 12 months, 24 months, 36 months
Visual performance as measured by high contrast visual acuity at 6 m
Differences in visual performance between test and control contact lenses
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale where a higher score indicates a better outcome
Differences in visual performance between test and control contact lenses
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Differences in bulbar hyperemia grading between test and control contact lenses.
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia
Differences in limbal hyperemia grading between test and control contact lenses.
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Universitari de la Visió
Terrassa, Barcelona, Spain
Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)
Santiago de Compostela, Galicia, Spain
Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid
Madrid, Spain
Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness
Differences in palpebral roughness grading between test and control contact lenses.
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in corneal staining grading between test and control contact lenses.
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining
Differences in conjunctival staining grading between test and control contact lenses.
Time frame: 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
Binocular vision as measured by heterophoria in prism diopters at 3 m
Differences in heterophoria at 3 m between test and control contact lenses.
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by heterophoria in prism diopters at 40 cm
Differences in heterophoria at 40 cm between test and control contact lenses.
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm
Differences in monocular accommodative facility at 40 cm between test and control contact lenses.
Time frame: 1 week, 6 months, 18 months, 30 months
Binocular vision as measured by monocular accommodative response in diopters at 40 cm
Differences in monocular accommodative response at 40 cm between test and control contact lenses.
Time frame: 1 week, 6 months, 18 months, 30 months
Corneal topography as measured by flat keratometry measurement in diopters
Differences in flat keratometry measurements between test and control contact lenses.
Time frame: Baseline, 12 months, 36 months
Corneal topography as measured by steep keratometry measurement in diopters
Differences in steep keratometry measurements between test and control contact lenses.
Time frame: Baseline, 12 months, 36 months