Cataract
Conditions
Interventions
Experimental group:Phaco + Toric IOL implantation was performed, and in the experimental group, patients were implanted with AT TORBI 709M Toric IOL.
Control group:Phaco + Toric IOL implantation was performed, and in the experimental group, patients were implanted with Acrysof SN6AT Toric IOL
Sponsors
Changzhou Third People’s Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients clinically diagnosed with cataract (lens opacity grade higher than C2N2P1 of the Lens Opacities Classification System) and planned to undergo phacoemulsification of the opaque lens combined with IOL implantation; 2. Diagnosed with regular corneal astigmatism >= 0.75 D in one or both eyes; 3. Expecting to be free of glasses for distance vision after surgery; 4. Other refractive media are transparent except for cataract and possible mild vitreous opacity; 5. Aged between 40 and 90 years old, with normal cognitive ability, and able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with unstable corneal or biometric measurement results; 2. Those whose best corrected distance visual acuity of the affected eye is expected to be <= 0.6 decimal visual acuity according to the medical judgment of the researcher; 3. Those with ocular organic diseases that may affect refraction and visual function, such as glaucoma, chronic or severe uveitis, pathological myopia, microphthalmos or macrophthalmos, severe corneal diseases, large alternating strabismus, deformed or obviously abnormal pupils, severe dry eye syndrome, amblyopia, etc.; 4. Those with diseases that may affect the stability of the lens capsule, such as lens zonular relaxation or rupture, lens capsule fibrosis, lens dislocation or subluxation, pseudoexfoliation syndrome, etc.; 5. Those with progressive retinal or optic nerve diseases (including macular diseases), such as diabetic retinopathy, retinal detachment, proliferative vitreoretinopathy, vitreomacular traction syndrome, macular degeneration, epiretinal membrane, macular hole, retinitis pigmentosa, Stargardt disease, and severe optic nerve diseases, etc.; 6. Those who have any other ophthalmic surgery plans during the study period, or have undergone corneal refractive, corneal transplantation or intraocular surgery in the past, including prophylactic peripheral iridectomy and peripheral retinal laser photocoagulation, etc.; 7. Those with corneal endothelial cell count lower than 2000 cells/mm^2; 8. Those with ocular infections or inflammations such as conjunctivitis, keratitis, dacryocystitis, etc. that may increase the risk of postoperative infection; 9. Patients with traumatic or congenital cataracts; 10. Those who have participated in other medical device clinical trials within 30 days before screening or drug clinical trials within 60 days; 11. Pregnant or lactating women; 12. Those with ocular diseases that may cause side effects on the stability of the implant as judged by the researcher; 13. Those with systemic acute or chronic diseases that may increase the surgical risk or affect the visual prognosis as judged by the researcher, such as poorly controlled diabetes, low immune function, Sjogren's syndrome, etc.; 14. Those who are not suitable for Toric IOL implantation as judged by the researcher or as mentioned in the product manual, expert consensus, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rotation of Toric IOL within the capsular bag;Decentration of Toric IOL in the capsular bag;Tilt of the toric IOL within the capsular bag; | — |
Countries
China
Contacts
Public ContactXin Gao
Changzhou Third People’s Hospital
Outcome results
None listed