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

NCT07336069 | Completed

• 1 other identifier: 2022QXPJ001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Vision Aids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Motion sickness score

  30 min

• The first tear film break-up time

  30 min

• distance eye position

  30 min

• near eye position

  30 min

• AC/A

  30 min

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

"Langshiqng" visual aid device 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center

Beijing, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: July 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: January 13, 2026

Record last verified: 2025-07

Locations

CN (1)