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Enrolling by invitation NCT07679477

Management of Myopia in University Students With DIMS-TED Spectacle Lenses

No phase Interventional Myopia Progression

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: DIMS TED spectacle lenses, Single vision spectacle lenses.
Who it may be relevant to
Registry conditions: Myopia Progression. Basic parameters: 18 years — 23 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 →

Official title

Management of Myopia in University Students Using Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses.

Overview

The purpose of the study is to quantify the effectiveness of Hoya MiyoSmart IQ (DIMS-TED) spectacle lenses in slowing the rate of myopia progression in university students.

Detailed description

MiyoSmart spectacle 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 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 DIMS TED spectacle lenses
    Spectacle lenses for myopia management
  • Device Single vision spectacle lenses
    Single vision spectacle lenses as control

Primary outcome measures

  • Axial length [Time frame: 24 months]
  • Cycloplegic SER [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Myopic students studying at university
  • Aged 18-23 years at the start of the study
  • Show evidence of axial length growth of at least 0.06mm prior to entry into 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 the protocol
  • Agree to accept either the control or test lenses 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
  • Myopic Rx up to -10D
  • Astigmatism up to 4D
  • Anisometropia <1.75D
  • Binocular Vision anomalies (such as tropia)
  • Taking medications that affect pupil size or accommodation
  • A known allergy to tropicamide

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

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

Publications

  • Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475. doi: 10.1038/s41598-023-32700-7. PMID 37015996
  • Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29. PMID 31142465
  • Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2. PMID 37126362
  • 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. PMID 30817830

Identifiers

NCT: NCT07679477 · E1305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗