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Good eyesight eye patch for children and adolescents with visual fatigue: a randomized, double-blind, placebo-controlled clinical trial

Good eyesight eye patch for children and adolescents with visual fatigue: a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035154
Enrollment
Unknown
Registered
2020-08-02
Start date
2020-09-15
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual fatigue

Interventions

Experimental group (Eye patch for adolescents with good vision):2 times a day (lunch break and before bedtime or before dinner and before bedtime), close your eyes and apply them to your eyes for 15 m
Control group (Eye patch simulator for adolescents with good vision):2 times a day (lunch break and before bedtime or before dinner and before bedtime), close your eyes and apply them to your eyes for

Sponsors

Eye Optometry Hospital affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Ages 8 to 14 (including 8 and 14), regardless of gender; (2) There is one of the following chief complaints of visual fatigue: (1) Visual impairment: not lasting in close work or reading, temporary blurred or double vision; Eye discomfort: eye distention, eye pain, dry eye, burning eye, tearing, itching eye, foreign body sensation and orbital pain; Systemic symptoms: easy fatigue, headache, dizziness, memory loss, severe even nausea, vomiting, and anxiety, irritability and other neurotic symptoms; (3) Have certain behavioral ability, cooperate with treatment and observation seriously, and sign informed consent form and participate voluntarily with his guardian.

Exclusion criteria

Exclusion criteria: (1) Strabismus: including intermittent exotropia and various dominant strabismus; (2) History of eye surgery; (3) Other eye diseases affecting vision, such as eye trauma, congenital eye diseases, etc.; (4) Eye drops or other measures are being used to treat visual fatigue (such as artificial tears); (5) Patients with serious primary diseases such as cardiovascular, liver, kidney, hematopoietic system and systemic immune diseases; (6) Those who are allergic to the skin or to the pharmaceutical ingredients contained in the test articles; (7) Those who have participated in other clinical trials in the past 1 month; (8) Those who are considered unfit to participate in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Visual fatigue score;Visual Acuity Test (naked eye and best Corrected visual Acuity);Equivalent ball mirror;Tear film rupture time;Regulating function;Contrast sensitivity;

Countries

China

Contacts

Public ContactQiuxia Zhang
zhangqiuxia@xinsm.com+86 13837151676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026