Cataract
Conditions
Interventions
Experimental group:The intraocular lens with the model of SM60AS produed by Simedice company
control group:The intraocular lens with the model of SN60WF produed by Alcon company
Sponsors
Zhongshan Opthalmic center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old; 2. For patients with age-related cataract who are expected to undergo phacoemulsification and intraocular lens implantation, the intraocular nucleus hardness is 1-3 grade; 3. The subjects whose best corrected far vision was less than 4.7 (standard logarithmic visual acuity chart); 4. The subjects whose diopters are expected to be implanted from + 10.0d to + 30d; 5. Patients who can understand the purpose of the trial voluntarily participate in the study and sign the informed consent form by the patient himself or his legal guardian, and can complete the postoperative follow-up on time.
Exclusion criteria
Exclusion criteria: 1. Patients with corneal endothelial cell count less than 2000 cells / mm2; 2. Patients who had a history of trauma or intraocular surgery; 3. The patients with other eye diseases, such as small or large eyeballs, color vision defect, eye movement, which are not suitable for cataract extraction combined with intraocular lens implantation by researchers Inflammatory reaction, corneal dystrophy, shallow anterior chamber, malignant glaucoma or uncontrolled high intraocular pressure, vitreous dislocation, macular disease, pigment epithelial cell disease, diabetic retinopathy, optic atrophy, etc; 4. Patients with contraindications of intraocular lens implantation in capsular bag, such as posterior capsule rupture or separation of ciliary body band; 5. Patients with traumatic cataract, congenital cataract, complex cataract and drug cataract were operated on; 6. Cataract patients with recurrent iritis, severe atrophy of iris and allergic dermatitis; 7. Patients who need eye joint operation; 8. Patients with severe or unstable systemic diseases; 9. Patients with fasting blood glucose >=9 mmol/L before operation; 10. Patients who participated in clinical trials of other drugs or medical devices within 30 days before screening; 11. Patients who are in use or need to use drugs during the study period that may affect their vision, such as oral ethambutol, isoniazid, chlorpromazine, etc; 12. The researchers judged the patients whose contralateral eyes were blind to function; 13. Patients without supervision or unable to follow up according to the doctor's advice; 14. Pregnant and lactating women; 15. Other situations that were not suitable for selection were judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficiency of the test product at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The best corrected distance visual acuity of surgery eye;The refractive test results of surgery eye;The uncorrected distance visual acuity of surgery eye; | — |
Countries
China
Contacts
Public ContactMingqian Zhang
He'nan saimeishi Biotechnology Co., Ltd
Outcome results
None listed