Cataract
Conditions
Interventions
experimental group: tri-focus, astigmatism correction intraocular lens (AT LISA tri toric 939M/MP) implantation
Control group:IOL implantation
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years; 2. Volunteer to participate in this trial and have signed a written informed consent; 3. The cataract in the tested eye has indications for surgical treatment; 4. Regular corneal astigmatism >= 0.75D; 5. Intraocular lenses with spherical lens range -10.0D~+32.0D and cylindrical lens range +1.0D~+12.0D are required; 6. The investigator judged that the postoperative expected CDVA is less than or equal to 0.3LogMAR.
Exclusion criteria
Exclusion criteria: 1. Intraocular lens eye; 2. Have undergone corneal/refractive surgery, or have undergone keratoplasty; 3. Severe corneal dystrophy, or corneal inflammation, corneal edema, corneal opacity, corneal scarring, corneal punctate degeneration; 4. The corneal endothelial cell count is less than 2000/mm2; 5. Glaucoma; 6. Secondary diseases of the anterior segment, such as neovascularization of the iris, primary iris atrophy, hemorrhage in the anterior chamber; 7. Pathological miosis, capsular bag or ciliary muscle deformity; 8. After the test eye has dilated, the pupil diameter is less than 6mm; 9. Inflammation of the tested eye, such as iritis, uveitis, etc.; 10. Aniridia or iris deformity; 11. Choroidal hemorrhage; 12. Have undergone retinal or vitreous surgery; 13. Any clinically diagnosed or OCT confirmed fundus disease, such as macular degeneration, retinal damage (including diabetic retinopathy), etc.; OCT scans cannot get fundus images; 14. Optic nerve atrophy; 15. Amblyopia; 16. Microphthalmia or macrophthalmia; 17. The test eye has no valid data obtained by the IOL Master optical biometer; 18. Subjects who participated in or intend to participate in clinical trials of other drugs or medical devices during the trial period within 3 months before the screening visit of this trial; 19. Female subjects who are pregnant or breastfeeding; 20. Other conditions determined by the investigator to be unsuitable for enrollment or intolerance of surgery, such as: suffering from other serious diseases, severe infectious diseases, allergies to test materials, allergies to pre- and post-operative medications or contraindications, combined use The drugs may affect the vision or the judgment of the postoperative results, and the follow-up cannot be followed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected distance vision;Middle vision with best corrected distance vision;Best corrected near vision with distance vision; | — |
Countries
China
Contacts
Public ContactYao Ke
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed