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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myopia Progression
• Intervention / Treatment: Device: DIMS TED spectacle lenses; Device: Single vision spectacle lenses

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.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Huddersfield, United Kingdom
    • University of Huddersfield
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD7 1NP
      • University of Bradford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 > 10D
• Astigmatism >4D
• Anisometropia >1.75D
• Binocular Vision anomalies (such as tropia)
• Taking medications that affect pupil size or accommodation
• A known allergy to tropicamide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: DIMS TED scpectacle lenses; Active Comparator: Single vision spectacle lenses	Device: DIMS TED spectacle lenses; Spectacle lenses for myopia management
Active Comparator: Active Comparator: Single vision spectacle lenses	Device: Single vision spectacle lenses; Single vision spectacle lenses as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change in axial length relative to baseline	24 months
Cycloplegic SER	Change in spherical equivalent cycloplegic autorefraction relative to baseline	24 months

Collaborators and Investigators

• Sponsor: University of Bradford
• Collaborators: University of Huddersfield; Hoya Vision Care
• Investigators: Principal Investigator: Kathryn Webber, MOptom, University of Bradford; Principal Investigator: Niall Hynes, PhD, University of Huddersfield; Principal Investigator: Neema Ghorbani-Mojarrad, PhD, University of Bradford; Principal Investigator: Sophie Coverdale, PhD, University of Bradford; Principal Investigator: Cheryl Hill, University of Bradford

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: E1305 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No