Cataract
Conditions
Interventions
Trial group:Intraocular lens implantation after cataract phacoemulsification
Control group:Intraocular lens implantation after cataract phacoemulsification
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 40 and 85 years (inclusive), no gender restriction; 2. Diagnosed with senile cataract in one or both eyes, expecting to undergo cataract phacoemulsification extraction with intraocular lens implantation and have a requirement for spectacle independence; if both eyes of the subject meet the inclusion criteria, the eye with worse corrected vision or better fundus condition will be selected for this study; 3. The expected power range of the Multifocal Intraocular Lens (MIOL) for the study eye is between +5D and +30.0D (inclusive); 4. Nuclear hardness grade of the study eye’s lens = 4; 5. Preoperative Best Corrected Visual Acuity (BCVA) = 0.5 or the subject requests surgery; 6. Anticipated postoperative astigmatism = 1.00D for the study eye; 7. Kappa angle of the study eye < 0.5mm; 8. Able to understand the purpose of the trial, voluntarily willing to participate, and able to sign the informed consent form either by the subject themselves or their legal guardian, and capable of completing postoperative follow-ups on schedule.
Exclusion criteria
Exclusion criteria: 1. Corneal endothelial cell count < 2000 cells/mm²; 2. Fasting blood glucose = 8.3 mmol/L prior to surgery; 3. History of ocular trauma within 3 months before screening; 4. Previous intraocular or corneal surgery; 5. Presence of strabismus, amblyopia, or nystagmus; 6. Coexisting ocular conditions deemed unsuitable by the investigator for undergoing phacoemulsification with multifocal IOL implantation, such as irregular astigmatism, corneal scarring, corneal dystrophy, keratoconus, keratitis, corneal degeneration, uveitis, severe iris atrophy, iris floppy syndrome, microphthalmia or megalophthalmia, color vision defects, active ocular inflammation, advanced glaucoma or uncontrolled high intraocular pressure, macular disease, retinal pigment epithelium disorders, diabetic retinopathy, retinal detachment, choroidal detachment, optic nerve atrophy, etc.; 7. Patients assessed by the investigator to have a high risk of zonular rupture during phacoemulsification (e.g., zonular laxity, zonular dialysis, lens subluxation or dislocation, pseudoexfoliation syndrome, Marfan syndrome) or contraindications to in-the-bag IOL implantation (e.g., posterior capsule rupture, ciliary sulcus detachment); 8. Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), hematologic, systemic diseases, neurological disorders, or psychiatric conditions; 9. Use of medications that may increase surgical risk or affect vision as determined by the investigator, such as amiodarone, chlorpromazine, ethambutol, digitalis, chloroquine, etc.; 10. Need for concurrent ocular procedures including limbal relaxing incisions, intravitreal injections, retinal laser therapy, or other surgeries that the investigator deems should be excluded; 11. Participation in another drug or medical device clinical trial within 30 days prior to screening; 12. Pregnant, breastfeeding women, or those planning to become pregnant soon; 13. Any other conditions that the investigator determines would make the patient unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with best corrected distance visual acuity of 0.5;The percentage of patients with intermediate visual acuity (76cm) of 0.5 at best corrected distance visual acuity;The percentage of patients with best corrected near visual acuity (38cm) of 0.5; | — |
Secondary
| Measure | Time frame |
|---|---|
| In the open hole well, and near vision;Best corrected far, in and near vision;Best corrected distant vision under the vision, best corrected distant vision of near vision; | — |
Countries
China
Contacts
Public ContactKe Ma
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed