Cataract
Conditions
Interventions
Test group:Both eyes implanted with Vivity IOLs
Sponsors
Boao Super Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Able to comprehend and sign an informed consent form. 2)Adults aged at and above 18 years, diagnosed with binocular cataracts. 3)Pre-operative regular corneal astigmatism less than 1.0 D. 4)Planned bilateral cataract removal by phacoemulsification. 5)Calculated IOL spherical equivalent between +15.0 D and +25.0 D. (with targeted diopter of 0.0 D). 6)The preoperative best-corrected distance visual acuity in one eye is worse than or equal to 0.2 LogMAR. 7)Potential postoperative best corrected distance visual acuity of 0.2 logMAR or better in one eye based on the physician's professional judgment.
Exclusion criteria
Exclusion criteria: 1)History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathologic change including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, ARMD, glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve. 2)Corneal Endothelial Cell Count less than 2000/mm2. 3)History of recurrent anterior segment/posterior segment inflammation. 4)Clinically significant corneal diseases (epithelium, stromal, and/or endothelium) may, according to the investigator's medical opinion, adversely affect visual outcomes. These ocular pathologies include but are not limited to old significant corneal scars (including Salzmans nodular degeneration), active or inactive keratitis with compromise of the refractive capability of the cornea, keratoconjunctivitis sicca with compromise of visual function, active keratouveitis, endothelial dystrophy (Fuchs and non-guttate), keratoconus, etc. (Note: Patients with any pathological manifestations that may potentially affect postoperative visual acuity should not be included in this study) 5)Clinically significant/severe dry eye that would affect study measurements based on the investigators expert medical opinion. 6)Previous intraocular surgery history. 7)Pregnancy or lactation during study or planning to be pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes. 8)Current or past history of amblyopia or monofixation syndrome with poor stereoscopic vision. 9)Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject (e.g., Tamsulosin Hydrochloride – Flomax) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome). 10)Any subject currently participating in another investigational drug or device study that may confound the results of this investigation. 11)Any other ocular or systemic co- morbidity that, in the investigators medical opinion, may confound the results of this study or prohibit the completion of the study assessments or increase the risk for the subject. 12)Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL (e.g., patients of exfoliation Syndrome, Marfan syndrome). 13)Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI). 14)Patients who can only undergo cataract surgery in one eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Monocular Distance Corrected Intermediate Visual Acuity(DCIVA)(66cm);Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) (40cm); | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of best-corrected distance visual acuity in one eye reached 0.2 LogMAR or above; | — |
Countries
China
Contacts
Public ContactWei Chen
Outcome results
None listed