Low Vision Aids
Conditions
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.
Interventions
DEVICELangshiqng 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.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthenopia score | 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
| Measure | Time frame | Description |
|---|---|---|
| The first tear film break-up time | 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 |
| distance eye position | 30 min | The distance eye position of the participants was measured using a Maddox rod after the 30-min reading task |
| near eye position | 30 min | The near eye position of the participants was measured using a Maddox rod after the 30-min reading task |
| Motion sickness score | 30 min | Participants completed the Motion sickness Subjective Scale questionnaire post 30-minute reading session. |
| Accommodative responses | 30 min | Accommodative responses were measured using a comprehensive refractometer after the 30-min reading task |
| Intra-ocular pressure | 30 min | Intra-ocular pressure were measured using a neural crest tumor after the 30-min reading task |
| visual acuity | 30 min | The visual acuity of the participants were measured using the EDTRS visual acuity chart after the 30-min reading task |
| AC/A | 30 min | AC/A of the participants was measured using Maddox rod after the 30-min reading task |
Countries
China
Outcome results
None listed