Exploring the Impact of Dynamic Defocus Display Schemes on Ocular Health Indicators
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Binocular Visual Function(amplitude of accommodation)
Study Overview
Brief Summary
The present study is designed to explore the effects of dynamic defocus display technology on ocular health parameters using rigorous scientific approaches. It further examines the mechanisms through which this technology alleviates visual fatigue, thereby providing robust clinical evidence to support its practical application and widespread adoption.
Detailed Description
Research Content Recruit adults who meet the inclusion criteria and have long-term use of VDT (Visual Display Terminal) devices for the trial.
Compare the impact of different dynamic defocus modes on the visual fatigue symptoms of the subjects.
Analyze the mechanisms through which dynamic defocus modes alleviate visual fatigue.
Research Outcome Measures Primary Outcome Measures and Definitions Binocular Visual Function: A series of assessments of visual ability, including accommodative function (amplitude of accommodation, accommodative facility) and vergence function (near point of convergence, AC/A ratio).
Secondary Outcome Measures and Definitions Critical Flicker Fusion Frequency (CFF): To evaluate the degree of eye fatigue, with lower measured values indicating a higher degree of fatigue.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
In this clinical trial, the masking is applied to the participants and the study staff who conduct the assessments. The participants are single-blinded, meaning they are unaware of the specific dynamic defocus mode they are assigned to during the trial. This is to ensure that their subjective responses, such as those recorded in the visual fatigue questionnaire, are not influenced by their knowledge of the intervention.
The study staff who perform the assessments, including the measurement of critical flicker fusion frequency (CFF), accommodative function, and other ocular health indicators, are also blinded to the group assignments. This helps to prevent any potential bias in the data collection process, ensuring that the measurements are objective and reliable.
The randomization sequence and group assignments are managed by a third-party institution, which maintains the integrity of the blinding. Only after all data have been collected and the initial analysis is complete will the bl
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged between 20 and 40 years, regardless of gender;
- •Refractive anisometropia ≤2.5D and corrected visual acuity of 1.0 or above in both eyes;
- •Habitual long-term use of electronic devices with LED light sources, such as computers and smartphones;
- •Currently not using any other blue light protection products or having ceased the use of such products for at least 2 weeks;
- •No known visually significant ophthalmic diseases;
- •Willing to participate in the trial and having signed the informed consent form.
Exclusion Criteria
- •Abnormal accommodative function or other visual function abnormalities (e.g., strabismus, amblyopia);
- •Severe dry eye or history of ocular medication use;
- •Acute or chronic ocular surface inflammation, keratoconus, history of ocular surgery (e.g., refractive surgery), systemic diseases, or other conditions (e.g., wearing orthokeratology lenses and using atropine);
- •Photosensitivity, history of epilepsy, etc.;
- •Individuals unable to cooperate with the examination.
Outcomes
Primary Outcomes
Binocular Visual Function(amplitude of accommodation)
Time Frame: Baseline (before intervention), immediately after the 50-minute video-watching task for each of the five sessions, totaling ten completions per participant.
The amplitude of accommodation refers to the maximum amount of accommodative power that the eye can exert to focus on near objects, typically measured in diopters.
Binocular Visual Function（accommodative facility）
Time Frame: Baseline (before intervention), immediately after the 50-minute video-watching task for each of the five sessions, totaling ten completions per participant.
Accommodative facility, measured using a 2D flipper in cycles per minute (cpm), reflects the eye's ability to rapidly and efficiently change focus between near and far objects, indicating the dynamic functioning of the accommodative system.
Secondary Outcomes
- Critical Flicker Fusion Frequency(CFF)(Baseline (before intervention), immediately after the 50-minute video-watching task for each of the five sessions, totaling ten completions per participant.)
- Refractive error status(Baseline (before intervention), immediately after the 50-minute video-watching task for each of the five sessions, totaling ten completions per participant.)
- Visual Fatigue Questionnaire Score(Baseline (before intervention), immediately after the 50-minute video-watching task for each of the five sessions, totaling ten completions per participant.)