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Not yet recruiting NCT07686289

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

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KG1, KG2, KG3, KG4.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 8 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Axial length [Time frame: 1 hour]

Eligibility criteria

Inclusion criteria

  • Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
  • Sign written Informed Consent (and the California Bill of Rights, if applicable).
  • Be between age 8-24 (inclusive) and able to understand and assent to participation.
  • Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
  • Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
  • Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better in each eye.
  • Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion criteria

  • Unable or unwilling to provide informed consent and assent.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Pregnant or lactating or expect to become pregnant during the trial (by self-report).
  • Evidence of systemic or ocular abnormality, infection or disease.
  • Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).
  • Anisometropia ≥ 2.00.
  • Subjects who have undergone corneal refractive surgery.
  • Use atropine or other anticholinergic drug within the past month.
  • Employees or immediate family members of employees of study sites or sponsor.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07686289 · KV-JAX-RCT-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗