Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05888792
• Collaborator: HOYA Lens Thailand LTD. (Industry)
• Enrollment: 118
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Other: Variant of Defocus Incorporated Spectacle lens (DG2)	N/A

Detailed Description

The variant of Defocus Incorporated Spectacle lenses (DG2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (DG2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (DG2 lens) group for first 12 months. After 12 months, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months.Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (DG2 lens) group for first 12 months. After 12 months, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
• Primary Purpose: Treatment
• Official Title: Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope: A Randomised Control Trial
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Feb 28, 2026
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Single vision lens group Subjects in single vision lens group will receive a pair of single vision lenses for the first year of study. They will then receive a pair of DG2 lenses for the second year of the study.
Experimental: DG2 lens group Subjects in DG2 lens group will receive a pair of DG2 lenses over the 2-year study.	Other: Variant of Defocus Incorporated Spectacle lens (DG2); DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously

Outcome Measures

Primary Outcome Measures

1. Cycloplegic refraction change in spherical equivalent refraction (SER) [Baseline, 1st year and 2nd year]

   Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured

Secondary Outcome Measures

1. Axial length change [Baseline, 1st year and 2nd year]

   Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• SER: -1.00D or below

• Documented history of fast progressing myopia, either in SER or AL

• SER progression: 0.50D/year or more

• AL elongation: 0.27mm/year or more

• Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better

• Acceptance of random group allocation and the masked study design

• Anisometropia of 1.50 D or less

• Astigmatism of 2.00 D or less

Exclusion Criteria:

• Strabismus and binocular vision abnormalities

• Ocular and systemic abnormalities

• Prior experience of myopia control

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry, The Hong Kong Polytechnic University	Hung Hom		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• HOYA Lens Thailand LTD.

Investigators

• Principal Investigator: Dennis Yan Yin Tse, PhD, School of Optometry, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT05888792
• Other Study ID Numbers: H-ZGET
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Hong Kong Polytechnic University: Myopia; Defocus
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jun 5, 2023