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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center
Beijing, China
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.
Time frame: 30 min
Motion sickness score
Participants completed the Motion sickness Subjective Scale questionnaire post 30-minute reading session.
Time frame: 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
Time frame: 30 min
distance eye position
The distance eye position of the participants was measured using a Maddox rod after the 30-min reading task
Time frame: 30 min
near eye position
The near eye position of the participants was measured using a Maddox rod after the 30-min reading task
Time frame: 30 min
AC/A
AC/A of the participants was measured using Maddox rod after the 30-min reading task
Time frame: 30 min
Accommodative responses
Accommodative responses were measured using a comprehensive refractometer after the 30-min reading task
Time frame: 30 min
Intra-ocular pressure
Intra-ocular pressure were measured using a neural crest tumor after the 30-min reading task
Time frame: 30 min
visual acuity
The visual acuity of the participants were measured using the EDTRS visual acuity chart after the 30-min reading task
Time frame: 30 min
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.