Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
NCT ID: NCT05955638
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
84 participants
INTERVENTIONAL
2024-01-01
2028-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MiSight dual focus contact lens
MiSight contact lenses
Contact lens for myopia management.
Proclear single vision contact lens
Proclear contact lenses
Single vision contact lens as control
Interventions
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MiSight contact lenses
Contact lens for myopia management.
Proclear contact lenses
Single vision contact lens as control
Eligibility Criteria
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Inclusion Criteria
* Be aged 18-21 years at the start of the study
* Show evidence of recent myopia progression prior to commencement of Stage 2 of the study.
* Have read the patient information sheet and be happy to sign the consent forms
* Be willing to adhere to the visit schedule and wearing times described in this protocol
* Agree to lens wearing times of at least 10 hours per day, 6 days per week
* Agree to accept either the control or test lens as assigned by the randomisation
* Have BCVA of +0.10 logMAR or better in each eye
Exclusion Criteria
* Amblyopia
* Ocular pathology such as keratoconus or recurrent corneal infections
* Myopic Rx \> 10D
* Astigmatism \>1D
* Anisometropia \>1.75D
* Binocular Vision anomalies (such as Tropia)
* Medications that affect pupil size or accommodation
* A known allergy to fluorescein or tropicamide
* Biomicroscopic findings that would contraindicate contact lens wear
* The investigator considers that it is not in the best interest of the subject to participate in the study.
18 Years
21 Years
ALL
Yes
Sponsors
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University of Huddersfield
OTHER
CooperVision International Limited (CVIL)
INDUSTRY
University of Bradford
OTHER
Responsible Party
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Principal Investigators
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Kathryn Webber, MOptom
Role: PRINCIPAL_INVESTIGATOR
University of Bradford
Matthew Cufflin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bradford
Edward Mallen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bradford
Niall Hynes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Huddersfield
Locations
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University of Bradford
Bradford, West Yorkshire, United Kingdom
University of Huddersfield
Huddersfield, , United Kingdom
Countries
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References
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Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367.
Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.
Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873.
Jacobsen N, Jensen H, Goldschmidt E. Does the level of physical activity in university students influence development and progression of myopia?--a 2-year prospective cohort study. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1322-7. doi: 10.1167/iovs.07-1144.
Jorge J, Almeida JB, Parafita MA. Refractive, biometric and topographic changes among Portuguese university science students: a 3-year longitudinal study. Ophthalmic Physiol Opt. 2007 May;27(3):287-94. doi: 10.1111/j.1475-1313.2007.00475.x.
Kinge B, Midelfart A, Jacobsen G, Rystad J. Biometric changes in the eyes of Norwegian university students--a three-year longitudinal study. Acta Ophthalmol Scand. 1999 Dec;77(6):648-52. doi: 10.1034/j.1600-0420.1999.770608.x.
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
McCullough SJ, O'Donoghue L, Saunders KJ. Six Year Refractive Change among White Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS One. 2016 Jan 19;11(1):e0146332. doi: 10.1371/journal.pone.0146332. eCollection 2016.
Pesudovs K, Garamendi E, Elliott DB. A quality of life comparison of people wearing spectacles or contact lenses or having undergone refractive surgery. J Refract Surg. 2006 Jan-Feb;22(1):19-27. doi: 10.3928/1081-597X-20060101-07.
Ruiz-Pomeda A, Perez-Sanchez B, Valls I, Prieto-Garrido FL, Gutierrez-Ortega R, Villa-Collar C. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1011-1021. doi: 10.1007/s00417-018-3906-z. Epub 2018 Feb 3.
Tilia D, Diec J, Ehrmann K, Falk D, Fedtke C, Conrad F, Wu R, Bakaraju RC. Visual Performance and Binocular/Accommodative Function of S.T.O.P. Contact Lenses Compared With MiSight. Eye Contact Lens. 2023 Feb 1;49(2):63-70. doi: 10.1097/ICL.0000000000000950. Epub 2022 Oct 19.
Wolffsohn JS, Kollbaum PS, Berntsen DA, Atchison DA, Benavente A, Bradley A, Buckhurst H, Collins M, Fujikado T, Hiraoka T, Hirota M, Jones D, Logan NS, Lundstrom L, Torii H, Read SA, Naidoo K. IMI - Clinical Myopia Control Trials and Instrumentation Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M132-M160. doi: 10.1167/iovs.18-25955.
Other Identifiers
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E1060
Identifier Type: -
Identifier Source: org_study_id