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A real-world study on the use of soft hydrophilic contact lenses for visual correction in adult astigmatism patients

A real-world study on the use of soft hydrophilic contact lenses for visual correction in adult astigmatism patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070780
Enrollment
Unknown
Registered
2023-04-23
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

ametropia

Interventions

Experimental group:Wear contact lenses

Sponsors

Shaanxi Eye Hospital, Xi 'an People's Hospital (Xi 'an Fourth Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Patients over the age of 18; 2) Patients with binocular spherical mirror powers ranging from 0.00D to 10.00D (including 0.00D and -10.00D), astigmatism powers ranging from -0.50D to -3.75D (including -0.50D and -3.75D), and astigmatism axes ranging from 0 to 180 °; 3) Patients with optimal corrected visual acuity (for remote use) of both binocular frames reaching 0.8; 4) Those with normal fundus as judged by a doctor; 5) Patients who can complete at least 3 months of follow-up; 6) Those who are not allergic to any component of contact lenses or contact lens care products; 7) Those who are not pregnant, breastfeeding, or have no recent pregnancy plans; 8) Patients without contraindications; 9) Those who can understand the purpose of the follow-up study, voluntarily participate and have the informed consent form signed by the subjects themselves.

Exclusion criteria

Exclusion criteria: 1) Those who suffer from systemic diseases that may affect the eyes and cannot wear soft contact lenses as determined by the researcher, such as lupus erythematosus, scleroderma, uncontrollable diabetes, etc; 2) People with eye diseases who cannot wear soft contact lenses as determined by the researcher, such as acute or chronic eye inflammation, glaucoma, abnormal corneal perception, corneal epithelial defect, corneal endothelial cell reduction, severe dry eye, etc; 3) Individuals with a history of contact lens allergies or allergies to contact lens care products; 4) Individuals with a history of eye injury or intraocular surgery; 5) Patients with any intraocular pressure greater than 21mmHg; 6) Slit lamp inspection is abnormal, but it is not ruled out that the abnormality is = level 1; 7) Patients with BUT = 5s; 8) Individuals who do not have the necessary hygiene conditions for wearing soft glasses, such as dispersed dust, drugs, aerosols (such as hair gel, volatile chemicals), and dust in their living or working environment; 9) Patients who are using or need to use drugs that may cause dry eyes or affect vision (such as penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, ethambutol, etc.) during follow-up study; 10) Those who have worn rigid contact lenses within 30 days; 11) Individuals who have participated in soft contact lens testing within 7 days before screening, other medical device testing within 30 days, and drug testing within 3 months; 12) Pregnant women, breastfeeding or recently planned pregnancies; 13) Those who are unable to wear contact lenses according to medical advice and follow up on time; 14) Other situations that the researcher determines are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Glassed vision;Beauty effects;

Secondary

MeasureTime frame
Contact lens correction of vision;

Countries

China

Contacts

Public ContactYe Lu

Biomedical ethics review committee of Xi'an People's Hospital (Xi'an Fourth Hospital)

dryelu@126.com+86 029 61220086

Outcome results

None listed

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