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Postoperative Visual function Investigation of Vivinex Impress, a posterior chamber intraocular lens with enhanced Depth of Focus combined with Inserter, in patients with cataract

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	cataract
Date of first enrollment	03/09/2025
Target sample size	33
Countries of recruitment
Study type	Interventional
Intervention(s)	The patients who will receive cataract surgery to insert a Vivinex Impress under a general practice will take the following tests; 1) ophthalmologic tests using an ETDRS visual acuity chart (CTS-1500), unapproved medical device in Japan, before and after the surgery, and 2) a questionnaire (McAlinden QoV), which is not usually performed in general practice, after the surgery.

Outcome(s)

Primary Outcome

1) Uncorrected binocular visual acuity by distance at 3 months after surgery

Secondary Outcome

1) Corrected binocular visual acuity at far distance by distance at 3 months after surgery 2) Corrected binocular visual contrast sensitivity at far distance at 3 months after surgery 3) Binocular depth-of-focus curves at 3 months after surgery 4) Usage of eyeglass 5) Visual performance and subjective symptoms in both eyes 6) Course of changes in subjective refraction 7) Course of changes in uncorrected/corrected visual acuity at far distance 8) Adverse events/product defects

Key inclusion & exclusion criteria

Age minimum	>= 22age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who meet all of the following criteria are included in this study: 1)Patients with binocular cataracts, who are aged of 22 years of age or older, and who have planned to receive lens extraction by phacoemulsification 2)Target postoperative refraction is emmetropia 3)Patients who are expected to obtain corrected visual acuity at far distance of 0.7 or higher after surgery 4)Patients with corneal astigmatism of less than 1.0D at consenting 5)Patients who have planned to receive 1st eye surgery within 60 days after consenting 6)Patients who have planned to receive second eye surgery within 30 days of the first eye surgery 7)Patients whose applicable lens spherical power is assumed to be +6.0 D or higher and +30.0 D or less 8)Patients who can be followed-up for 3 months after surgery 9)Patients who can understand the contents of informed consent documents and give their consent in written form by themselves by their free will
Exclude criteria	Patients who fall into any of the following criteria are excluded from participating in the study; 1)Patients with history of corneal transplantation 2)Patients with history of refractive surgery 3)Patients with history of or intraocular surgery 4)Patients with corneal irregular astigmatism 5)Patients with injuries (atopic dermatitis, etc.) on ocular surface (cornea, lacrimal fluid, conjunctiva, etc.) that may affect visual acuity 6)Patients with extreme shallow anterior chamber (except for bulging cataracts) 7)Patients with pupillary abnormalities (except for physiological pupillary discrepancies) 8)Patients with glaucoma 9)Patients with iris neovascularization 10)Patients with clinical finding or predisposing factor (pseudoexfoliation of the lens, exfoliation syndrome, etc.) of weakened or broken zonule that may affect stability of intraocular lens 11)Patients with traumatic cataract 12)Patients with severe lens opacity, who cannot receive adequate funduscopy 13)Patients whose ocular axis length cannot be measured using the IOL Master or optical biometers with equivalent accuracy 14)Patients with current or history of retinal detachment 15)Patients with diabetic retinopathy 16)Patients with retinal degeneration that may affect visual acuity 17)Patients with choroidal hemorrhage that may affect visual acuity 18)Patients with current or history of uveitis 19)Patients with optic atrophy 20)Patients with strabismus or amblyopia 21)Patients with congenital eye anomaly 22)Patients with nystagmus that may affect accuracy of ophthalmological examinations 23)Patients who have planned to receive endophthalmic surgery during the study period other than the study lens insertion in this study 24)Patients with mental or cognitive impairment that may affect accuracy of ophthalmological examinations 25)Patients who are participating in other clinical studies 26)Patients who had participated in other clinical studies till 30 days prior to preoperative examinations 27)Patients who are judged to be inappropriate to participate in this study by investigators due to systemic or ophthalmic comorbidity etc.