NCT07679477

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
39mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Oct 2025Oct 2029

Study Start

First participant enrolled

October 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 25, 2026

Last Update Submit

July 9, 2026

Conditions

Myopia Progression

Outcome Measures

Primary Outcomes (2)

  • Axial length

    Change in axial length relative to baseline

    24 months

  • Cycloplegic SER

    Change in spherical equivalent cycloplegic autorefraction relative to baseline

    24 months

Study Arms (2)

Experimental: DIMS TED scpectacle lenses

EXPERIMENTAL

Active Comparator: Single vision spectacle lenses

Device: DIMS TED spectacle lenses

Active Comparator: Single vision spectacle lenses

ACTIVE COMPARATOR

Active Comparator: Single vision spectacle lenses

Device: Single vision spectacle lenses

Interventions

DIMS TED spectacle lensesDEVICE

Spectacle lenses for myopia management

Experimental: DIMS TED scpectacle lenses
Single vision spectacle lensesDEVICE

Single vision spectacle lenses as control

Active Comparator: Single vision spectacle lenses

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bradford

Bradford, West Yorkshire, BD7 1NP, United Kingdom

Location

University of Huddersfield

Huddersfield, United Kingdom

Location

Related Publications (4)

  • 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: 37015996BACKGROUND

  • 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: 31142465BACKGROUND

  • 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: 37126362BACKGROUND

  • 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: 30817830BACKGROUND

Study Officials

  • Neema Ghorbani-Mojarrad, PhD

    University of Bradford

    PRINCIPAL INVESTIGATOR

  • Kathryn Webber, MOptom

    University of Bradford

    PRINCIPAL INVESTIGATOR

  • Sophie Coverdale, PhD

    University of Bradford

    PRINCIPAL INVESTIGATOR

  • Niall Hynes, PhD

    University of Huddersfield

    PRINCIPAL INVESTIGATOR

  • Cheryl Hill

    University of Bradford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

July 13, 2026

Record last verified: 2026-06

Locations

GB(2)