cataract
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant Level: (1) Age >= 50 years and = 4; (3) Planned to undergo phacoemulsification combined with intraocular lens implantation; (4) Pupil size is 6 mm or larger after dilation; (5) Corneal endothelial cell count is 1500 cells/mm^2 or higher. 3. Study Eye Selection: The participant must have at least one eye that meets all the inclusion criteria (both at the Participant and Study Eye levels) and does not meet any of the listed exclusion criteria. 4. Only one eye per participant can be the Study Eye. If both eyes are eligible at the time of enrollment, the eye with the higher nuclear (N) grade will be selected. If both eyes have the same nuclear grade, the eye with worse visual acuity will be selected. If both eyes have the same nuclear grade and the same visual acuity, the Study Eye will be chosen by mutual agreement between the investigator and the participant prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Participant Level: (1) Judged by the investigator to be unsuitable for participation in this clinical trial for other reasons (e.g., unstable systemic conditions, blood pressure, blood glucose, severe cardiovascular disease, renal disease, etc.); (2) Blood pressure >180/110 mmHg (systolic >180 mmHg or diastolic >110 mmHg); if blood pressure can be controlled below this threshold with antihypertensive medication, the participant may be considered for inclusion; (3) Myocardial infarction or other cardiac disease requiring hospitalization, cerebral infarction, transient ischemic attack, or acute heart failure within 4 months prior to enrollment; (4) Women of childbearing potential (i.e., currently pregnant, breastfeeding, or planning to become pregnant within the next 2 years). Female potential study participants should be asked about the possibility of pregnancy, and the investigator will determine when a pregnancy test is necessary; (5) Currently participating in other clinical trials. 2. Study Eye Level: (1) History of ocular trauma or surgery; (2) Presence of other ocular diseases (e.g., glaucoma, diabetic retinopathy, or high myopia); (3) Other ocular factors that may complicate surgery (e.g., small pupil, shallow anterior chamber).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The best-corrected distance visual acuity at 1 day postoperatively.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coefficient of variation of corneal endothelial cell size;The percentage loss of central corneal endothelial cell density compared to the preoperative baseline at post-operative day 1 and post-operative;Percentage of hexagonal cells;Central corneal thickness;Corneal endothelial cell density;The best-corrected distance visual acuity; | — |
Countries
China
Contacts
The Zhongshan Ophthalmic Center,Sun Yat-sen University