Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorThe Hong Kong Polytechnic University

About this trial

The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hong Kong Chinese

Age at enrolment: 6 - 13 years

Myopia in spherical power: -1.00D to -5.00D in both eyes

Astigmatism: equal or less than 2.00D

Disqualifiers

Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)

Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development

Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health

Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Defocus Incorporated Multiple Segments lens (D1)

    Other intervention

    D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

  • Modified Defocus Incorporated Multiple Segments lens (D2)

    Other intervention

    D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Single vision lens groupNo intervention 0 interventions
Group B: D1 lens groupExperimental treatment 1 intervention
Group C: D2 lens groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Choroidal thickness changes

Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.

Time frame
Baseline, every week for 1 month, every 6 months over 1 year

Secondary outcomes

1

Cycloplegic refraction change in spherical equivalent refraction (SER)

Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.

Time frame
Baseline, 6 and 12 months
2

Axial length changes

Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.

Time frame
Baseline, 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

HOYA Lens Thailand LTD.

Collaborator