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Completed

NCT Number: NCT07336069

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

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.

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Key information

Conditions

Low Vision Aids

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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.

Primary outcomes

  1. Asthenopia score

    Time frame: 30 min

    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.

Secondary outcomes

  1. Motion sickness score

    Time frame: 30 min

    Participants completed the Motion sickness Subjective Scale questionnaire post 30-minute reading session.

  2. The first tear film break-up time

    Time frame: 30 min

    The first tear break-up time of the participants was measured using the ocular Surface Synthesis analyzer after the 30 min reading task

  3. distance eye position

    Time frame: 30 min

    The distance eye position of the participants was measured using a Maddox rod after the 30-min reading task

  4. near eye position

    Time frame: 30 min

    The near eye position of the participants was measured using a Maddox rod after the 30-min reading task

  5. AC/A

    Time frame: 30 min

    AC/A of the participants was measured using Maddox rod after the 30-min reading task

  6. Accommodative responses

    Time frame: 30 min

    Accommodative responses were measured using a comprehensive refractometer after the 30-min reading task

  7. Intra-ocular pressure

    Time frame: 30 min

    Intra-ocular pressure were measured using a neural crest tumor after the 30-min reading task

  8. visual acuity

    Time frame: 30 min

    The visual acuity of the participants were measured using the EDTRS visual acuity chart after the 30-min reading task

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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