A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
1 other identifier
interventional
35
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 7, 2026
June 1, 2026
5 months
June 30, 2026
June 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Axial length
1 hour
Study Arms (10)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALSequence 3
EXPERIMENTALSequence 4
EXPERIMENTALSequence 5
EXPERIMENTALSequence 6
EXPERIMENTALSequence 7
EXPERIMENTALSequence 8
EXPERIMENTALSequence 9
EXPERIMENTALSequence 10
EXPERIMENTALInterventions
Unique Kubota Glass optical defocus parameter
Unique Kubota Glass optical defocus parameter
Unique Kubota Glass optical defocus parameter
Unique Kubota Glass optical defocus parameter
Unique Kubota Glass optical defocus parameter
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2026
First Posted
July 7, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 7, 2026
Record last verified: 2026-06