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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05955638
Other study ID # E1060
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date September 1, 2028

Study information

Verified date December 2023
Source University of Bradford
Contact Martin Brinkworth, PhD
Phone +441274233584
Email nhs-ethics@bradford.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to quantify the effectiveness of Coopervision MiSight contact lenses in slowing the rate of myopia progression in university students.


Description:

MiSight contact lenses have been shown to be a safe and effective way of managing myopia progression in children aged 8-12 years. However, myopic progression is not limited to children of this age group and MiSight lenses have also been shown to be effective in older children aged 11-16 years. There is evidence that progression also occurs in university students. The researchers are therefore investigating the effectiveness of this intervention in a group of UK-based University students.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date September 1, 2028
Est. primary completion date September 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 21 Years
Eligibility Inclusion Criteria: - Be a myopic students studying at university - 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: - Previous myopia control use (optical or pharmacological) - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MiSight contact lenses
Contact lens for myopia management.
Proclear contact lenses
Single vision contact lens as control

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Bradford Coopervision, Inc., University of Huddersfield

References & Publications (12)

Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in axial length relative to baseline Baseline, 24 months
Primary Change in spherical equivalent cycloplegic autorefraction relative to baseline Baseline, 24 months
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