Juvenile MyopiaMAPLENCT04126057

Myopia Assessment of Two Manufacturing Processes

A study testing SightGlass Vision DOT Spectacle Lenses in people with Juvenile Myopia, run by SightGlass Vision, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Juvenile Myopia
What is being tested?: SightGlass Vision DOT Spectacle Lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 5 sitesUnited States
Study dates: 2 Dec 2019to 16 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Sabal Eye Care
Longwood, Florida, 32779
SUNY School of Optometry
New York, New York, 10036
Kannarr Eye Care
Pittsburg, Kansas, 66762
Advanced Eyecare PC
Raytown, Missouri, 64133
William J Bogus, OD, FAAO
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)

Conditions: Juvenile Myopia
Being tested: SightGlass Vision DOT Spectacle Lenses
Keywords: Myopia
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SightGlass Vision DOT Spectacle LensesDevice
Also called SightGlass Vision
Subjects randomized to test vs control, left eyes and right eyes

Study groups in NCT04126057
Study group	Role	What they receive
DOT Spectacle Lenses using Manufacturing Method A	Experimental	Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A Receives: 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 Receives: Device: SightGlass Vision DOT Spectacle Lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201916 Sep 2020

First posted14 Oct 2019
Study start2 Dec 2019
Primary completion15 Sep 2020
Study completion16 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Juvenile MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04126057
Sponsor's protocol ID: CPRO-1908-001
Acronym: MAPLE
Status last verified: Dec 2021
First submitted: 10 Oct 2019
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Assessment of DOT Spectacles in Chinese Children
Juvenile Myopia, Myopia
Active, not recruiting
CYPRESS Efficacy and Safety Study Extension
Juvenile Myopia, Myopia
Active, not recruiting
Control of Myopia Using Novel Spectacle Lens Designs
Juvenile Myopia
Active, not recruiting
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
Myopia, Myopia Progression
Active, not recruiting
Myopia Control Spectacle Lens Cessation Study
Myopia, Myopia Progression

All Juvenile Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
ClinicalTrials.gov ID: NCT04126057
Acronym / sponsor ID: MAPLE / CPRO-1908-001
Conditions: Juvenile Myopia
Keywords: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: SightGlass Vision, Inc.Industry (pharma, biotech, devices)
Study start: 2 Dec 2019 (actual)
Primary completion: 15 Sep 2020 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 14 Oct 2019 (actual)
Results: Posted 25 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DOT Spectacle Lenses using Manufacturing Method A	Experimental	Device: SightGlass Vision DOT Spectacle LensesSingle vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
DOT Spectacle Lenses using Manufacturing Method B	Experimental	Device: SightGlass Vision DOT Spectacle LensesSingle vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B

Who may qualify

Ages: 6 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SightGlass Vision DOT Spectacle LensesAlso: SightGlass VisionSubjects randomized to test vs control, left eyes and right eyes	Device	DOT Spectacle Lenses using Manufacturing Method A, DOT Spectacle Lenses using Manufacturing Method B

Primary outcome

Change in Axial Length Progression From Baseline
Time frame: 6 months
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.

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DOT Spectacle Lenses Test	50	47
DOT Spectacle Lenses Control	50	46

Primary outcome: Change in Axial Length Progression From Baseline

Time frame: 6 months. Mean (Standard Deviation). Unit: mm

Measure	DOT Spectacle Lenses Using Test n = 43	DOT Spectacle Lenses Using Control n = 43
Value	0.046 (0.139)	0.047 (0.128)

Adverse events

Time frame: 6 months. Other adverse events reported at 4.65% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DOT Spectacle Lenses Using Test	0 of 43 (0%)	0 of 43 (0%)	0 of 43
DOT Spectacle Lenses Using Control	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Juvenile Myopia

Active, not recruiting
Assessment of DOT Spectacles in Chinese Children
Juvenile Myopia, Myopia
Active, not recruiting
CYPRESS Efficacy and Safety Study Extension
Juvenile Myopia, Myopia
Active, not recruiting
Control of Myopia Using Novel Spectacle Lens Designs
Juvenile Myopia
Active, not recruiting
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
Myopia, Myopia Progression
Active, not recruiting
Myopia Control Spectacle Lens Cessation Study
Myopia, Myopia Progression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Rappon, OD, MS, FAAO study chair

SightGlass Vision, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SightGlass Vision DOT Spectacle Lenses in people with Juvenile Myopia, run by SightGlass Vision, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Axial Length Progression From Baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.