Cataract
Conditions
Brief summary
The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.
Detailed description
This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.
Interventions
DEVICEFluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
DEVICEAcrySof IQ monofocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURECataract surgery
Standard cataract extraction with phacoemulsification
Sponsors
PowerVision
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity; * Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D); * Calculated IOL power within range. Key
Exclusion criteria
* Current medication that may affect accommodation; * Systemic disease or concomitant medication that may increase operative risk or confound results; * Ocular conditions that may predispose the subject for future complications; * Monocular subjects or subjects with significant permanent visual function loss in fellow eye; * Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye; * Grade 4 cataract of any type.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accommodative Amplitude (AA) | Month 6 postoperative | Accommodative amplitude is the ability of the eye to change its focus from distant to near objects. |
| Distance Corrected Visual Acuity | Month 6 postoperative | Visual acuity was measured with distance correction (plus or minus power) in place. |
| International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL | Up to Month 6 postoperative | Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accommodative Amplitude | Month 3 postoperative | Accommodative amplitude is a measure of the range of vision with good acuity. |
| Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity | Up to Month 6 postoperative | Plus lenses were placed over the subject's best distance manifest correction. |
| Uncorrected Visual Acuity | Up to Month 6 postoperative | Visual acuity was measured without correction in place. |
Outcome results
None listed