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Enrolling by invitation NCT05955638

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

No phase Interventional Myopia, Progressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MiSight contact lenses, Proclear contact lenses.
Who it may be relevant to
Registry conditions: Myopia, Progressive. Basic parameters: 18 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Change in axial length relative to baseline [Time frame: Baseline, 24 months]
  • Change in spherical equivalent cycloplegic autorefraction relative to baseline [Time frame: Baseline, 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 2 centers
  • University of Bradford — Bradford
  • University of Huddersfield — Huddersfield

Publications

  • Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367. PMID 31116165
  • 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. PMID 31343513
  • 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. PMID 35086120
  • 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. PMID 18385044
  • 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. PMID 17470242
  • 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. PMID 10634556
  • 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. PMID 20505205
  • 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. PMID 26783753

Identifiers

NCT: NCT05955638 · E1060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗