Cataract
Conditions
Interventions
Experimental group:Implantation of extended depth of focus intraocular lens (SV1)
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Adult patients (18-85 years old, inclusive) diagnosed with cataracts and indicated for surgical treatment; gender is not restricted. Patients expected to undergo phacoemulsification cataract extraction combined with intraocular lens implantation. Lens Opacities Classification System III (LOCS III) nuclear grading = 4. Patients expected to use intraocular lens power range between +10.0 to +30.0 diopters (inclusive). Best corrected visual acuity (BCVA) = 0.5 (decimal visual acuity). Kappa angle = 0.5 mm. Postoperative astigmatism expected to be = 0.75 diopters. Patients able to understand the purpose of the trial, willing to participate, sign the informed consent form personally or by their legal guardian, and able to complete postoperative follow-up on time.
Exclusion criteria
Exclusion criteria: Corneal endothelial cell count < 1500 cells/mm². Fasting blood glucose = 9 mmol/L preoperatively. History of ocular trauma affecting visual function, previous intraocular surgery, or corneal refractive surgery. Presence of strabismus, amblyopia, or nystagmus. Combined ocular diseases deemed unsuitable for phacoemulsification cataract extraction combined with extended depth of focus intraocular lens implantation by the investigator, such as irregular corneal astigmatism, corneal scarring, corneal degeneration, keratoconus, keratitis, corneal dystrophy, uveitis, severe iris atrophy, floppy iris syndrome, microphthalmia, or megalophthalmia, color vision deficiency, active ocular inflammatory response, advanced glaucoma, uncontrolled intraocular pressure, macular lesions, retinal pigment epithelial diseases, diabetic retinopathy, retinal detachment, choroidal detachment, optic nerve atrophy, etc. Patients with a high risk of zonular fiber rupture during phacoemulsification cataract extraction (e.g., zonular laxity, zonular detachment, lens dislocation or subluxation, pseudoexfoliation syndrome, Marfan syndrome) or contraindications for intraocular lens implantation in the capsular bag (e.g., posterior capsule rupture, ciliary body separation). Patients with severe or unstable systemic diseases, such as systemic lupus erythematosus, Sjogren's syndrome, etc. Patients using medications that may increase surgical risk or affect vision, such as amiodarone, chlorpromazine, ethambutol, digitalis, chloroquine, etc., as determined by the investigator. Patients requiring combined ocular treatments, including limbal relaxing incisions, intraocular drug injections, retinal laser treatments, or other combined treatments deemed necessary to exclude by the investigator. Participation in other drug or medical device clinical trials within 30 days prior to screening. Pregnant or breastfeeding women, or those planning to become pregnant soon. Presence of severe anxiety, depression, or other psychological or psychiatric disorders. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected distance visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distance-corrected intermediate visual acuity; | — |
Countries
China
Contacts
Public ContactXuemin Li
Peking University Third Hospital
Outcome results
None listed