cataract
Conditions
Interventions
experimental group:Intensity SL intraocular lens was implanted
control group:Implant an intraocular lens AT LISA tri 839MP
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Adults, 18 years of age or older at the time of enrollment, no gender restriction; (2) Subjects with cataract in one eye or bilateral eyes with planned cataract removal by phacoemulsification and combined with posterior chamber IOL implantation; (3) Subjects who require an IOL lens power within the range of +10.0 to +30.0 D estimated by investigators; (4) Expected postoperative astigmatism of 1.00D or less (=1.00D); (5) Preoperative Kappa angle < 0.5 mm or less than half the diameter of the central diffractive optic of the MIOL (Kappa angle: distance from the center of the pupil to the visual axis); (6) Preoperative BCDVA = 0.3 logMAR; (7) Clear intraocular media other than cataracts in study eye; (8) Fundus visualization is possible; Visible fundus of the study eye, without retinal or optic nerve disease; (9) If the subject is a contact lens wearer, willing to discontinue wearing rigid gas permeable contact lenses for 3 30 days or soft contact lenses for 3 14 days prior to the preoperative visit; (10) Able to comprehend and sign an informed consent (additional impartial witnesses are required if the subject is unable to read); (11) Patients had sufficient cognitive awareness to comply with the examination procedures of this study and were willing to participate in regular follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Preoperative irregular corneal astigmatism keratoconus or other abnormal corneal; (2) Subjects who had previous intraocular or corneal surgery (e.g., laser keratomileusis, corneal transplantation, etc.) that may affect the accuracy of IOL power calculations or restore of visual acuity; Severe corneal dystrophy or other clinically significant corneal abnormalities, such as keratitis, keratopathy, corneal inflammation, infection, corneal edema, corneal opacity, corneal scar, etc.; (3) Inability to achieve secure IOL placement in the designated position, that may affect postoperative IOL location (e.g., anterior capsular pericapsular instability, zonule laxity or dehiscence, floppy iris, posterior synechiae to the capsular bag, Marfan's syndrome, etc.) or contraindicate to intra capsular bag IOL implantation (e.g., posterior capsular membrane rupture, ciliary body separation, etc.); (4) Study eye with any previous or current ocular pathology that may affect visual acuity (e.g., severe dry eye, uncontrolled glaucoma or advanced glaucoma, ocular injury, corneal pathologies) , or combined progressive retinal disease (e.g., diabetic retinopathy, macular degeneration, macular membrane, Stargardt's disease, retinitis pigmentosa and optic nerve disease etc.,), uveitis, pseudoexfoliation syndrome, aniridia or iris atrophy, vitreous pathologies (such as vitreomacular traction syndrome, etc.), optic nerve atrophy, etc.; (5) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at 3.0~5.5 mm under mesopic/scotopic conditions), or less than 6.0mm after mydriasis/cycloplegia; (6) Preoperative corneal endothelial cell density below 2000 cells/mm2 ; (7) Inability to measure corneal keratometry or biometry (including but not limited to subjects unable to focus long enough to be measure, cataract density) or inability to obtain valid data during measurement of study eye. (8) Rubella cataract, traumatic cataract, congenital cataract and other types of cataracts; (9) Microphthalmia or macrophthalmia; (10) Amblyopia, dominant strabismus, nystagmus, etc.; (11) Pregnant, lactation, or planning to become pregnant during the course of the clinical trial, or subject who are unwilling to use effective contraception during the study; (12) Subjects who are expected to require secondary ocular surgical intervention or laser treatment (other than Nd:YAG capsulotomy) or retinal laser treatment; (13) Subjects who require combined ocular surgery, such as corneal limbal relaxing incisions, intra-vitreous injection, retinal laser treatment and other surgery need to be ruled out determinate by the investigator; (14) Subjects who have participated in any other drug or medical device clinical trials within 90 days prior to the screening visit in this trial, or intend to participate in other clinical trials during this study; (15) Subjects with special occupations (e.g. professional drivers, etc.) or excessive expectations of postoperative vision, or overly sensitive, anxious, depressed, or perfectionism; (16) Conditions predicted to cause future significant visual acuity losses or could confound the results of study based on the investigator’s judgment, such as patient’s inability to adapt to simultaneous multiple retinal images; (17) Subjects with uncontrolled systemic diseases that may have adverse impacts or confound outcomes, such as uncontrolled diabetes mellitus, severe psychiatric and/or psychological disorders, immu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of the product: 6 months after surgery, the study eyes were evaluated by ETDRS visual acuity chart to achieve 0.3logMAR or better in the best corrected far vision, the middle vision under the best corrected far vision, and the near vision under the best corrected far vision.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity;naked vision;diopter; | — |
Countries
China
Contacts
Public ContactKe Yao
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed