Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast (WALNUT)

SightGlass Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Spectacle lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03761758

P/639/18/SG

Details and patient eligibility

About

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

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

21 participants in 3 patient groups

Lens Design 1

Experimental group

Description:

Spectacle lenses design 1, fitted into spectacle frames

Treatment:

Device: Spectacle lenses

Lens Design 2

Experimental group

Description:

Spectacle lenses design 2, fitted into spectacle frames

Treatment:

Device: Spectacle lenses

Lens Design 3

Experimental group

Description:

Spectacle lenses design 3, fitted into spectacle frames

Treatment:

Device: Spectacle lenses