NCT04126057

Brief Summary

Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed
Last Updated

January 25, 2022

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

October 10, 2019

Results QC Date

October 29, 2021

Last Update Submit

December 30, 2021

Conditions

Juvenile Myopia

Keywords

Myopia

Outcome Measures

Primary Outcomes (1)

  • Change in Axial Length Progression From Baseline

    Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.

    6 months

Study Arms (2)

DOT Spectacle Lenses using Manufacturing Method A

EXPERIMENTAL

Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A

Device: SightGlass Vision DOT Spectacle Lenses

DOT Spectacle Lenses using Manufacturing Method B

EXPERIMENTAL

Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B

Device: SightGlass Vision DOT Spectacle Lenses

Interventions

SightGlass Vision DOT Spectacle LensesDEVICE

Subjects randomized to test vs control, left eyes and right eyes

Also known as: SightGlass Vision
DOT Spectacle Lenses using Manufacturing Method ADOT Spectacle Lenses using Manufacturing Method B

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 6 and 14 years old (inclusive) with myopia
  • Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye
  • Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D

You may not qualify if:

  • Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.)
  • Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Advanced Eyecare PC

Raytown, Missouri, 64133, United States

Location

SUNY School of Optometry

New York, New York, 10036, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Joe Rappon, OD, MS, FAAC
Organization
SightGlass Vision, Inc.
joe@sightglassvision.com
678-642-9117

Study Officials

  • Joseph Rappon, OD, MS, FAAO

    SightGlass Vision, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

December 2, 2019

Primary Completion

September 15, 2020

Study Completion

September 16, 2020

Last Updated

January 25, 2022

Results First Posted

January 25, 2022

Record last verified: 2021-12

Locations

US(5)