NCT06992635

Brief Summary

This study aimed to evaluate the effect of anti-reflection (AR) and circularly polarized (CP) film on video display terminal (VDT) induced dry eye and asthenopia after limited time and close distance of visual tasks under light and dark environment, searching for new strategy for eye-protective electronic screen. The study was randomized, double-blind and controlled. Subjects were enrolled following the criteria: diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D. and randomly divided into control, AR, AR+CP group in light or dark environment. Character searching, gaming and video tasks utilizing specific smartphones for totally 45 minutes were performed. Researchers measured the indexes of dry eye and asthenopia before and after tasks to evaluate impacts induced by VDT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

November 20, 2025

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 8, 2025

Last Update Submit

November 17, 2025

Conditions

Dry Eye Disease (DED)Asthenopia

Outcome Measures

Primary Outcomes (3)

  • Flourescence tear break-up time

    Drop a drop of physiological saline onto a sodium fluorescein test strip. Gently touch the middle of the conjunctiva of both lower eyelids of the examinee with the test strip respectively, and instruct the examinee to blink their eyes gently and look straight ahead. The examiner observed the tear film of the examinee with cobalt blue light under a slit lamp. The time of tear film rupture was the time from the examinee opening their eyes to the appearance of the first black spot on the tear film. Three TBUT tests were detected and recorded for each eye respectively, and the average and maximum values were taken.

    2 months

  • HFC (high frequency component of accommodative fluctuation)

    The SCR mode of the ACOMOREF K-MODEL computerized optometer was adopted. The subjects were asked to keep a close eye on the image. The image distance was gradually moved from infinity to 1m, 60cm, and 30cm, and remained at each of the four distances for 20 seconds. The equipment would analyze and record the high-frequency fluctuations of the subjects' ciliary muscles, known as HFC. After the test of the first eye, Take a 20-second break to test the second eye.

    2 months

  • non-invasive tear break-up time

    The Oculus ocular surface comprehensive analyzer was adopted. The examinees sat upright in front of the instrument and were asked to blink their eyes lightly and then look at the red marked object. The instrument automatically conducted ocular surface image analysis to obtain and record the first NIBUT and average NIBUT of the examinees

    2 months

Secondary Outcomes (4)

  • tear meniscus height

    2 months

  • corneal fluorescein staining

    2 months

  • computer vision symptom scale 17

    2 months

  • Schirmer I test

    2 months

Study Arms (2)

light condition

SHAM COMPARATOR

use smartphone under light condition for 45 minutes

Behavioral: using non-processing screensBehavioral: using AR+CP screens

dark condition

EXPERIMENTAL

use smartphone under dark condition for 45 minutes

Behavioral: using non-processing screensBehavioral: using AR+CP screens

Interventions

using non-processing screensBEHAVIORAL

ask subjects to use non-processing screens

dark conditionlight condition
using AR+CP screensBEHAVIORAL

ask subjects to use AR+CP screens

dark conditionlight condition

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • have basic reading comprehension skills and to be older than 18 years old. 2.diopter of both eyes not exceeding -6.0D and anisometropia not exceeding 2.0D.

You may not qualify if:

  • presbyopia or decreased regulation function, ocular inflammation and disease, worn contact lens within 1 month, history of eye surgery within 6 months, lactating or pregnant woman, have severe systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Dry Eye SyndromesAsthenopia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 28, 2025

Study Start

June 1, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

November 20, 2025

Record last verified: 2024-05

Locations

CN(1)