Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision

Sun Yat-sen University

Status: Completed

Conditions: Low Vision Aids

Treatments: Device: "Langshiqng" visual aid device

Study type: Interventional

Funder types: Other

Identifiers

NCT07336069

2022QXPJ001

Details and patient eligibility

About

This clinical trial aims to assess the efficacy and safety of the Shilangqing Smart Reading Aid, a head-mounted device integrating XR and AI technologies, in improving reading performance and quality of life among children with low vision. The study employs a multicenter, randomized, controlled design with two parallel groups: an experimental group using the Shilangqing device and a control group using traditional optical magnifiers. Participants will undergo a 12-week intervention period, with primary outcomes focusing on reading speed, accuracy, and user satisfaction. Secondary outcomes include changes in visual acuity, eye health metrics (e.g., tear film stability, visual fatigue), and device-related adverse events. The trial builds on preliminary data from Zhongshan Ophthalmic Center and user feedback indicating high efficacy and safety. An estimated 120 participants aged 6-18 years with best-corrected visual acuity of 0.05 to <0.3 will be recruited from multiple sites in China. Results will inform clinical adoption and regulatory approvals for low-vision assistive devices.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The study included healthy individuals older than 18 years of age with a best-corrected visual acuity (BCVA) of <0.1 logarithm of minimum angle of resolution (logMAR) and no ongoing or prior history of ocular or systemic disease.

Exclusion criteria

• The study excluded healthy individuals younger than 18 years of age with a best-corrected visual acuity (BCVA) of >0.1 logarithm of minimum angle of resolution (logMAR) with ongoing or prior history of ocular or systemic disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Experimental Group

Experimental group

Description:

Using the "Shilangqing" device, conduct reading practice at a brightness level of 400 nit, and measure the eye health indicators before and after the reading session.

Treatment:

Device: "Langshiqng" visual aid device