Cataract
Conditions
Interventions
Experimental group:Extended Depth of Focus Intraocular Lenses (Wuxi leiming Shikang)
Control group:One-piece folding intraocular lens (Wuxi leiming Shikang)
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, men and women; 2. Cataract in one or both eyes, patients expected to undergo phacoemulsification and intraocular lens implantation. If the patient's eyes meet the inclusion criteria, patients with poor corrected visual acuity or better fundus conditions were selected for this study; 3. The best corrected far vision<=0.5; 4. The corrected diopter of intraocular lens is expected to be between +5.0Dand +34.0D; 5. Preoperative astigmatism<=1.0D; 6. Patients who can complete the six-month follow-up; 7. Be able to understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other eye diseases before operation, such as congenital microphthalmos and megalopia, glaucoma, severe corneal dystrophy, macular lesion, diabetic retinopathy, severe optic atrophy, severe shallow anterior chamber, choroidal hemorrhage,rupture of posterior capsule or separation of ciliary band,etc; 2. Those who had retinal detachment or retinopathy before operation; 3. History of recurrent anterior segment and posterior segment inflammation; 4. Patients with traumatic or congenital cataract; 5. Those who need combined eye surgery; 6. According to the judgment of the researcher, the nonoperative eye ignores the function or amblyopia; 7. Corneal endothelial cell count less than 1800/mm2; 8. Patients with a history of ocular trauma or intraocular surgery in recent three months; 9. Those who have undergone corneal refractive surgery or corneal transplantation; 10. Postoperative ocular inflammation, such as iritis, uveitis; 11. Aniridia or iris malformation; 12. Those who have participated in clinical trials of other drugs or medical devices within three months; 13. Accompanied by serious or unstable heart, liver, kidney, blood, mental and neurological dysfunction, and other diseases; 14. With surgical contraindications; 15. Patients who are using or need to use drugs affecting vision during the study; 16. Pregnant or lactating women, and those who plan to become pregnant within 6 months after surgery; 17. Unattended or unable to follow up according to the doctor's advice; 18. The investigator judged that the candidate was not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance corrected intermediate Visual Acuity of six months after operation;Best corrected distance visual acuity of six months after operation;Focal depth at 0.3LogMAR on defocus curve;The percentage of DCIVA less than or equal to 0.3 LogMAR of 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of BCDVA = 0.3LogMar of 6 months after operation;Best corrected distance visual acuity,Distance Corrected Intermediate Visual Acuity,Uncorrected distance visual acuity,Uncorrected intermediate visual acuity;Defocus curve;Expected diopter and diopter changes at 1 week, 1 month, 3 months and 6 months after operation;Contrast sensitivity at 6 months after operation;Visual quality satisfaction rate at 6 months after operation; | — |
Countries
China
Contacts
Public ContactWang Cong
Wuxi Leiming Shikang Technology Co.Ltd
Outcome results
None listed