A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass

Sponsor
Kubota Vision Inc.
Study ID
NCT07686289
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 24 Years
Healthy Volunteers
Accepted

Interventions

  • KG1 — DEVICE
    Unique Kubota Glass optical defocus parameter
  • KG2 — DEVICE
    Unique Kubota Glass optical defocus parameter
  • KG3 — DEVICE
    Unique Kubota Glass optical defocus parameter
  • KG4 — DEVICE
    Unique Kubota Glass optical defocus parameter
  • KG5 — DEVICE
    Unique Kubota Glass optical defocus parameter

Study Details

This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 6, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1
  • Experimental: Sequence 2
  • Experimental: Sequence 3
  • Experimental: Sequence 4
  • Experimental: Sequence 5
  • Experimental: Sequence 6
  • Experimental: Sequence 7
  • Experimental: Sequence 8
  • Experimental: Sequence 9
  • Experimental: Sequence 10

Primary Outcome Measure

Axial length [ Time Frame: 1 hour ]

Central Contacts

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