Cataract
Conditions
Interventions
Test Group:Treated with CATACURE100
Sponsors
Cataract Clinical Center, Eye Hospital WMU
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age range of 50-85 years old (inclusive), both males and females; 2) Diagnosed with age-related cataracts; 3) Cataract LOCS III grading for the study eye: NO/NC = grade 5, C = grade 5, P = grade 2; 4) Best corrected distance visual acuity (BCDVA) for the study eye between 0.2-0.6 LogMAR (inclusive); 5) Able and willing to follow instructions, including participating in all study assessments and visits as advised by the researcher, including being able to sit upright for at least 20 minutes (duration of treatment).
Exclusion criteria
Exclusion criteria: 1) The study eye has other eye conditions significantly affecting vision, including glaucoma, retinal disorders, amblyopia, optic neuropathy, high myopia, etc., which may either affect treatment or the ability of the study eye to be assessed post-treatment. 2) Any eye with active ocular inflammation during the screening period (including blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation, etc.). 3) Intraocular pressure > 21mmHg in the study eye. 4) Shallow anterior chamber in the study eye, defined as anterior chamber depth (ACD) 8.3mmol/L). 13) Diagnosed with severe cardiovascular diseases (cardiomyopathy or myocardial infarction, arrhythmia, angina pectoris, congestive heart failure, liver or kidney failure, etc.). 14) Pregnant or lactating women, and those planning to become pregnant during the study period. 15) Participation in drug clinical trials within the past 3 months or ongoing participation, or participation in other medical device clinical trials within the past 30 days. 16) The researcher considers other conditions unsuitable for enrollment (such as narrow palpebral fissure in the study eye, poor eye opening in the study eye, poor pupil dilation effect in the study eye, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in best-corrected distance visual acuity(BCVA) compared to baseline 90 days after the end of the last treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in best-corrected distance visual acuity compared to baseline.;The percentage of improvement of one line or more in best-corrected distance visual acuity compared to baseline.;The change in near visual acuity under best-corrected distance visual acuity, best-corrected near visual acuity, uncorrected distance visual acuity, and uncorrected near visual acuity compared to baseline.;Cataract LOCS III score;Visual Function Quality Assessment (VF-14);Contrast sensitivity; | — |
Countries
China
Contacts
Public ContactAyong Yu
Eye Hospital WMU
Outcome results
None listed