Presbyopia-induced visual fatigue
Conditions
Interventions
Experimental group:Zhangyanming tabletoral, 2 tablets a time, tid
Control group:Zhangyanming mimetic tablet oral, 2 tablets a time, tid
Sponsors
Eye System of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-65 years (including the critical value), male and female; 2. Meet the diagnostic criteria for presbyopia; 3. Meet the diagnostic criteria of western medicine visual fatigue; 4. Conforming to the TCM standards for syndrome differentiation of eye fatigue (Gan Shen Yin Xu Pattern); 5. During screening, the subjects can be equipped with frames, contact lenses or without lenses, and the corrected binocular far visual acuity >= 0.8 (standard logarithmic visual acuity chart test, decimal record); 6. Women were postmenopausal (>= 12 months after menopause), had undergone surgical sterilization, or consented to use effective contraception during the trial; Women of reproductive age or subjects who have gone through menopause less than 12 months must undergo a blood or urine pregnancy test during the screening period and the results must be negative; 7. Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Visual fatigue not caused by presbyopia, such as esotropia, exotropia (oblique Angle > 20 degree), high anisometropia, conjunctivitis, ptosis; 2. Patients with other eye diseases that may affect drug evaluation, such as glaucoma, uveitis, and severe fundus diseases (such as proliferative diabetic retinopathy, retinal detachment); 3. Patients who underwent corneal refractive surgery, cataract surgery, glaucoma surgery or strabismus surgery within 3 months before enrollment; 4. Dry eye related examinations were performed during screening, and the examination results supported the diagnosis of dry eye, but no corresponding treatment was performed or the patients had been diagnosed with dry eye but had been treated with drugs for less than 1 month;Tests to support the diagnosis of dry eye can be one of the following: (1) Tear film rupture time (TBUT) = 1.5 times the upper limit of normal, SCr > the upper limit of normal); 8. Known or suspected allergic history or severe adverse reaction to the test drug and its excipients, or allergic constitution; 9. Unable to cooperate or unwilling to cooperate because of neurological or mental illness; 10. Participants who had participated in other clinical trials within 3 months before enrollment; 11. Pregnant or lactating women, patients who have family planning in the past six months; 12. According to the judgment of the researcher, it is not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual fatigue symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Amplitude of binocular accommodation (AMP);Negative relative regulation (NRA);Positive relative regulation (PRA);Additional degree of presbyopia (Add);Organized Crime Threat Assessment (OCTA) examination;Short distance time with eyes;Tear film break-up time (TBUT);TCM syndrome score; | — |
Countries
China
Contacts
Public ContactQu Jia
Eye System of Wenzhou Medical University
Outcome results
None listed