Cataract
Conditions
Keywords
Cataract, Monofocal, Intraocular lens, Preloaded, Aphakic, Asqelio, aspicio, AST Products, ICARES
Brief summary
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.
Detailed description
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination. Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery. The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.
Interventions
DEVICEaspicio Monofocal IOL
A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery
Sponsors
ICARES Medicus, Inc.
AST Products, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye 2. Willingness to cooperate with and complete all post-operative visits 3. Ability to comprehend and sign an informed consent
Exclusion criteria
1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation). 2. Previous ocular surgery (including YAG-laser) or trauma 3. Clinically significant irregular astigmatism 4. Concomitant severe eye disease 5. Pregnant or lactating 6. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study 7. Concurrent participation in another drug or device investigation 8. May be expected to require other ocular surgery during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CDVA | 3 months after implantation | Photopic monocular best corrected distance visual acuity (CDVA), 400cm |
| Defocus curve | 3 months after implantation | Photopic monocular defocus curve, -4.0 D \~ +2.0 D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UDVA | 3 months after implantation | Photopic monocular uncorrected distance visual acuity (UDVA), 400cm |
| UIVA | 3 months after implantation | Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm |
| CIVA | 3 months after implantation | Photopic monocular corrected intermediate visual acuity (CIVA), 60cm |
| IOL glistening | 3 months after implantation | IOL glistening observation |
| PCO | 3 months after implantation | Posterior Capsular Opacification observation |
| Satisfaction questionnaire | 3 months after implantation | Satisfaction questionnaire |
| AE | 3 months after implantation | Signs of inflammation and AEs |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORYih-Shiou Hwang, MD
Chang Gung University Hospital
Outcome results
None listed