Cataract
Conditions
Interventions
Experimental group:Implantation of extended depth of focus intraocular lens (EDA601)
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Adults aged 18-85 years (inclusive) of any gender diagnosed with cataract in the study eye and indicated for surgical treatment; (2) Study eye is expected to undergo phacoemulsification cataract extraction combined with intraocular lens implantation; (3) Study eye has a lens nucleus grading of LOCS III = 4; (4) Study eye is expected to use an intraocular lens with a diopter range of +10.0 to +30.0D (inclusive); (5) Best-corrected distance visual acuity in the study eye is = 0.5 (decimal visual acuity); (6) Kappa angle = 0.5mm; (7) Expected postoperative astigmatism in the study eye is = 0.75D; (8) Capable of understanding the purpose of the trial, willing to participate, and able to sign the informed consent form either personally or via a legal guardian, and able to complete postoperative follow-ups on time.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Endothelial cell count of the cornea in the study eye < 2000 cells/mm²; (2) Fasting blood glucose level = 8.3 mmol/L preoperatively; (3) Study eye has a history of ocular trauma affecting visual function, history of intraocular surgery, or corneal refractive surgery; (4) Study eye is accompanied by strabismus, amblyopia, or nystagmus; (5) Study eye has other ocular diseases that, according to the investigator, make it unsuitable for phacoemulsification cataract extraction combined with extended depth of focus intraocular lens implantation, such as irregular corneal astigmatism, corneal scars, corneal degeneration, keratoconus, keratitis, corneal dystrophy, uveitis, severe iris atrophy, iris laxity syndrome, microphthalmos, or megalophthalmos, color vision deficiency, active ocular inflammation, advanced glaucoma or uncontrolled high intraocular pressure, macular degeneration, retinal pigment epithelial disease, diabetic retinopathy, retinal detachment, choroidal detachment, optic atrophy, etc.; (6) According to the investigator, patients with a high risk of zonular rupture during phacoemulsification cataract extraction (e.g., zonular laxity, zonular dehiscence, lens subluxation or dislocation, pseudoexfoliation syndrome, Marfan syndrome, etc.) or study eye has contraindications for in-the-bag intraocular lens implantation (e.g., posterior capsular rupture, ciliary body detachment, etc.); (7) Subjects with severe or unstable systemic diseases, such as systemic lupus erythematosus, Sjögren's syndrome, etc.; (8) According to the investigator, the use of medications that may increase surgical risk or affect vision, such as amiodarone, chlorpromazine, ethambutol, digitalis, chloroquine, etc.; (9) Study eye requires combined ocular treatment, including limbal relaxing incisions, intraocular drug injections, retinal laser treatment, or other combined treatments deemed necessary for exclusion by the investigator; (10) Participation in other drug or medical device clinical trials within 30 days prior to screening; (11) Pregnant or lactating women, or those planning to become pregnant soon; (12) Presence of severe anxiety, depression, or other psychological or mental disorders; (13) 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 ContactAyong Yu
Eye Hospital of Wenzhou Medical University
Outcome results
None listed