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To verify the safety and efficacy of nano-blue light anti-blue light eyeglasses for dry eye combined with asthenopia

To verify the safety and efficacy of nano-blue light anti-blue light eyeglasses for dry eye combined with asthenopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101512
Enrollment
Unknown
Registered
2025-04-25
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Dry eye with asthenopia

Interventions

Dry eye with asthenopia group:Nano anti-blue light eyeglasses

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participated in this clinical study and signed informed consent; 2. Age between 18-60 years old, regardless of gender; 3.Asthenopia can be diagnosed if one of the following symptoms occurs after vision. a. Visual impairment: intolerance to long-term vision, temporary blurred vision. b. Eye discomfort: dryness, burning sensation, photophobia, tearing, distending pain, pricking pain, orbital pain, itching, foreign body sensation, heavy eyelashes, abnormal blinking; 4.There are clinical symptoms and signs of dry eye, and the clinical examination meets one of the diagnostic criteria of the "Expert Consensus on dry Eye" (as follows) : a. One of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation; At the same time, FBUT=5 seconds or Schirmer? test (without topical anesthesia) =5mm/5min; b. When there is one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation, and 5 < FBUT=10 seconds or 5 < Schirmer I test (without topical anesthesia) =10mm/5min, at the same time, fluorescein staining is positive (=5 points) in the cornea and conjunctiva. 5.Have not participated in other clinical trials within 1 month; 6.Not using other treatment for dry eye, or using other treatment but has stopped for more than 1 month; 7.Refractive range: the spherical equivalent of binocular autorefraction was between +4.00D and -6.00D (including +4.00D and -6.00D). Anisometropia was less than 2.00D, and astigmatism was less than 2.00D. 8.The best corrected visual acuity of either eye was =0.8; 9.Viewing time in front of electronic screen devices =8 hours/day.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women or those who plan to have children recently; 2.Patients with a history of keratitis, blepharitis, pterygium, cataract, fundus related diseases, eyelid surface abnormalities, ocular malignant tumors, and ocular trauma; 3.Dry eye secondary to scarring, radiation, alkali burn, cicatricial pemphigoid or destruction of conjunctival goblet cells (e.g., vitamin A deficiency); 4.Had undergone intraocular surgery or intraocular laser surgery within the past 6 months, or had any eye and/or eyelid surgery planned during the trial period; 5.Tear film break-up time =0 seconds, or schirmer test =0 mm /5 minutes; 6.The number of staining points of the whole cornea was more than 30, patchy staining fusion or filamentous matter appeared. 7.Severe MGD patients (grade 4); 8.Combined with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; 9.Patients who could not stop wearing contact lenses during the trial; 10.Long-term systemic or ocular medication may affect the patients evaluated in the study; 11.Inability to wear glasses and follow up as required during the trial; 12If the investigator considered that the participant was not suitable for the trial; 13.Wearing anti-blue light lenses and related products within 6 months.

Design outcomes

Primary

MeasureTime frame
OQASTM II visual quality analysis;Intraocular pressure;Number of blinks;Visual function ;Thickness of tear film lipid layer;Corneal staining score;Tear film rupture time;Fundus condition;Ocular surface condition;Ocular Surface Disease Index (OSDI);Visual Analog Scale Score (VAS);Census version of the visual fatigue scale score;Tear secretion;

Countries

China

Contacts

Public ContactLei Tian

Bejing Tongren Hospital, Capital Medical Uniersity

tianlei0131@163.com+86 18600166885

Outcome results

None listed

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