NCT07340359

Brief Summary

This study aimed to evaluate the protective effects of yellow-light etching anti-glare (AG) screen on Digital Eye Strain (DES) induced by prolonged video display terminal (VDT) use under dim environment, Based on the proved positive effect of the circular polarization (CP) screen, providing insights for new eye-protection strategy in the highly digital modern era. In a randomized, double-blind controlled trial, 70 eligible volunteers (diopter ≤ -6.0D; anisometropia ≤ 2.0D) were divided into AG+CP or CP only groups. Participants performed a 2-hour e-book reading task using assigned AG+CP or CP only smartphones. Subjects' severity of DES pre- and post-reading were evaluated from two aspects: the degree of dry eye symptoms and asthenopia. Dry eye symptoms indicators (OSDI, TMH, NIBUT, FBUT, CFS, Schirmer I Test) and asthenopia indicators (CVSS17, Bulbar redness, HFC) were measured and compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

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

First Submitted

Initial submission to the registry

January 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

March 5, 2026

Status Verified

December 1, 2025

Enrollment Period

11 days

First QC Date

January 6, 2026

Last Update Submit

March 4, 2026

Conditions

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.

    1 month

  • 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.

    1 month

  • 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

    1 month

Secondary Outcomes (4)

  • tear meniscus height

    1 month

  • corneal fluorescein staining

    1 month

  • computer vision symptom scale 17

    1 month

  • Schirmer I test

    1 month

Study Arms (2)

yellow light AG group

EXPERIMENTAL

use yellow light AG smartphone

Behavioral: reading 2h on smartphone

control group

PLACEBO COMPARATOR

use non-yellow light AG smartphone

Behavioral: reading 2h on smartphone

Interventions

reading 2h on smartphone

control groupyellow light AG group

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, 2.ocular inflammation and disease, 3.worn contact lens within 1 month, 4.history of eye surgery within 6 months, 5.lactating or pregnant woman, 6.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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

January 10, 2026

Primary Completion

January 21, 2026

Study Completion

February 21, 2026

Last Updated

March 5, 2026

Record last verified: 2025-12

Locations