Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

Myopia, Progressive Clinical Trial

— MoMUS  

Official title:

Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05955638
• Other study ID #: E1060
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

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 all — Click 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