Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

NCT ID: NCT03761758

Last Updated: 2018-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lens Design 1

Spectacle lenses design 1, fitted into spectacle frames

Group Type EXPERIMENTAL

Spectacle lenses

Intervention Type DEVICE

Spectacle lenses with clear central apertures

Lens Design 2

Spectacle lenses design 2, fitted into spectacle frames

Group Type EXPERIMENTAL

Spectacle lenses

Intervention Type DEVICE

Spectacle lenses with clear central apertures

Lens Design 3

Spectacle lenses design 3, fitted into spectacle frames

Group Type EXPERIMENTAL

Spectacle lenses

Intervention Type DEVICE

Spectacle lenses with clear central apertures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spectacle lenses

Spectacle lenses with clear central apertures

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages between 6 and 12 years
* Myopia between -1.00 and -4.00 D

Exclusion Criteria

* Participating in any clinical or other research study
* Contact lens wearer
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joe Rappon, OD, MS

Role: STUDY_DIRECTOR

SightGlass Vision

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P/639/18/SG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Children's Viewing Behavior
NCT07229365 RECRUITING NA
Contact Lenses and Myopia
NCT02180347 COMPLETED
Myopia Prevention With Reading Glasses
NCT05030103 NOT_YET_RECRUITING NA
Lag of Accommodation With DOT Spectacle Lenses
NCT04700111 ACTIVE_NOT_RECRUITING NA
Enhancement of Emmetropization in Hyperopic Infants
NCT00574717 TERMINATED PHASE1/PHASE2