Cataract
Conditions
Interventions
Experimental group :Aspheric Toric Trifocal Intraocular Lens
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, regardless of gender. 2. Diagnosed with cataracts in at least one eye and scheduled to undergo phacoemulsification cataract extraction with intraocular lens implantation, with nuclear hardness of grade 1 to 3 in the surgical eye. 3. Desire to reduce dependence on glasses. 4. Expected intraocular lens power ranging from -10.0D to +30.0D. 5. Capable of understanding the trial's purpose, willing to participate, and having provided informed consent signed by the patient or their legal guardian, with commitment to complete all required postoperative follow-ups.
Exclusion criteria
Exclusion criteria: 1. Presence of other ocular conditions that are contraindications for intraocular lens implantation, such as microphthalmos or macrophthalmos, small pupil, malignant glaucoma, significant corneal dystrophy, uncontrolled high intraocular pressure, macular/retinal pigment epithelial lesions expected to significantly impair vision (e.g., diabetic retinopathy), severe optic atrophy, significant vitreous loss, chronic or severe uveitis, shallow anterior chamber (not caused by lens swelling), choroidal hemorrhage, posterior capsule rupture or zonular dehiscence (preventing stable IOL fixation), or other concomitant serious ocular diseases. 2. Presence of severe or unstable systemic diseases affecting the heart, liver, kidneys, lungs, endocrine system (including thyroid dysfunction), hematopoietic system, or serious psychiatric/neurological disorders. 3. Expected best-corrected distance visual acuity (BCDVA) worse than 0.5 (Snellen decimal equivalent) in the study eye. 4. Corneal endothelial cell density lower than 2000 cells/mm². 5. Presence of irregular corneal astigmatism in the study eye that is expected to affect postoperative visual quality. 6. History of retinal detachment or retinal disease in the study eye. 7. Presence of traumatic cataract or congenital bilateral cataracts in the study eye. 8. History of ocular trauma or intraocular surgery within the past 3 months in the study eye. 9. Previous corneal surgery in the study eye, such as corneal transplantation or excimer laser surgery (e.g., LASIK, PRK). 10. Habitual use of glasses for reading. 11. Occupational demands or daily activities requiring exceptionally high visual performance. 12. Professional drivers or individuals frequently engaged in outdoor work at night. 13. History of photophobia. 14. Presence of amblyopia. 15. Unrealistically high expectations for postoperative vision, or individuals deemed overly anxious, nervous, depressive, or overly critical. 16. Pre-existing ocular conditions that may adversely affect the stability of the implant. 17. Requirement for combined ocular surgery. 18. Abnormal electrocardiogram (ECG) or laboratory test results indicating a surgical contraindication. 19. Participation in any other drug or medical device clinical trial within 3 months prior to screening. 20. Current use or anticipated need during the study period for medications that may affect vision (e.g., chlorpromazine, ethambutol, digoxin, chloroquine). 21. Pregnancy, lactation, or planning pregnancy in the near future. 22. Lack of a guardian or inability to adhere to the required follow-up schedule per the study protocol. 23. Investigator's judgment that the fellow eye has no functional vision. 24. Any other condition considered by the investigator to make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance-corrected near visual acuity;Distance-corrected intermediate visual acuity;Best corrected distance visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depth of focus curve test;Far contrast sensitivity;Slit lamp exam;Uncorrected distance visual acuity;Uncorrected near visual acuity;Uncorrected intermediate visual acuity; | — |
Countries
China
Contacts
Public ContactAyong Yu
Eye Hospital of Wenzhou Medical University
Outcome results
None listed