Evaluation of the FluidVisionTM AIOL With an Improved Injector
This trial is active, not recruiting.
|Treatment||fluidvisiontm accommodating intraocular lens|
|Start date||January 2015|
|End date||March 2016|
|Trial size||60 participants|
|Trial identifier||NCT02418871, AIOL-2015-1|
The objective of this study is to evaluate the clinical outcomes of an accommodating intraocular lens (AIOL) designed to provide distance, intermediate, and near vision in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Budapest, Hungary||Peterfry Hospital||no longer recruiting|
|Budapest, Hungary||Semmelweiss University||no longer recruiting|
|Claremont, South Africa||John Hill Eye Laser Centre||no longer recruiting|
|Northcliff, South Africa||Visiomed Laser Centre||no longer recruiting|
|Queenswood, South Africa||Optimed Eye and Laser Centre||no longer recruiting|
|Somerset West, South Africa||Somerset Eye Clinic||no longer recruiting|
|Intervention model||single group assignment|
time frame: 3 months
time frame: 6 months
time frame: 12 months
Male or female participants at least 50 years old.
Inclusion Criteria: - eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction; - best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester); - predicted best corrected distance visual acuity to be 20/30 or better after cataract removal and AIOL implantation as determined by potential acuity meter (PAM) or other potential vision tests or surgeon estimation on both eyes; - ≤1.0 D of preoperative keratometric astigmatism (first operative eye only); - clear intraocular media other than cataract; - preoperative central endothelial cell density of 2200 cells/mm2 or more; - at least 50 years of age; - willing and able to comply with schedule for follow-up visits for 36 months after surgery; - calculated AIOL power within the range of investigational device; - provide written informed consent. Exclusion Criteria: - vulnerable population as defined in ISO 14155 (e.g. individuals with lack of autonomy due to mental disability, persons in nursing homes, and children) - taking medications that may affect accommodation (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents) - systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, uncontrolled diabetes as demonstrated by HbA1c values); - taking systemic medications that may confound the outcome or increase the risk to the subject, i.e. tamsulosin hydrochloride (Flomax) or other medications with similar side effects; - ocular conditions that may predispose for future complications (e.g. anterior segment pathology including glaucoma or potentially occludable angles, corneal dystrophy, ocular inflammation); - monocular patient or presence of significant permanent visual function loss in fellow eye; - previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye; - pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes; - diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future best corrected distance visual acuity worse than 20/30; - floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction; - conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome); - sensitivity to planned study medications; - simultaneous participation in other ophthalmic drug or device clinical trial; - does not have an intact capsulorhexis and posterior capsule at the time of cataract extraction and lens implantation; - baseline dilated pupil size <8mm in diameter; - ACD based on IOL Master <2.8 mm; - corneal diameter <10 mm in any meridian; - capsulorhexis size of <5.5 mm or >6.0 mm; - not within range of manufacturer's fitting algorithm - decentered capsulorhexis of >1.0 mm in relation to the limbus; - posterior capsular opacity observed after cataract extraction; - complicated cataract surgery that prevents attempted implantation of the AIOL (e.g.; pupillary constriction, poor visibility due to corneal edema).
|Official title||Clinical Evaluation of the FluidVisionTM Accommodating Intraocular Lens With an Improved Injector System|
|Principal investigator||Frederik J Potgieter|
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