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

The Research to Evaluate the Efficacy and Safety of the Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision (SLQ-001)

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.

Study Overview

• Status: Completed
• Conditions: Low Vision Aids
• Intervention / Treatment: Device: "Langshiqng" visual aid device

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Device: "Langshiqng" visual aid device; Using the "Langshiqng" visual aid device, conduct reading practice at a brightness level of 400 nit, and measure the eye health indicators before and after the reading session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthenopia score	Participants completed the Visual Fatigue Subjective Scale questionnaire post 30-minute reading session (MEMC and non-MEMC). This 20-item scale assessed eye strain, headaches, perceived clarity, and general comfort, with responses analyzed to identify differences in subjective visual fatigue between conditions.	30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion sickness score	Participants completed the Motion sickness Subjective Scale questionnaire post 30-minute reading session.	30 min
The first tear film break-up time	The first tear break-up time of the participants was measured using the ocular Surface Synthesis analyzer after the 30 min reading task	30 min
distance eye position	The distance eye position of the participants was measured using a Maddox rod after the 30-min reading task	30 min
near eye position	The near eye position of the participants was measured using a Maddox rod after the 30-min reading task	30 min
AC/A	AC/A of the participants was measured using Maddox rod after the 30-min reading task	30 min
Accommodative responses	Accommodative responses were measured using a comprehensive refractometer after the 30-min reading task	30 min
Intra-ocular pressure	Intra-ocular pressure were measured using a neural crest tumor after the 30-min reading task	30 min
visual acuity	The visual acuity of the participants were measured using the EDTRS visual acuity chart after the 30-min reading task	30 min

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022QXPJ001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No