N/A
Completed N=218
Clinical Investigation of the Next Generation Intraocular Lens
Source: ClinicalTrials.gov NCT03500198 ↗Enrolled (actual)
218
Serious AEs
4.6%
Results posted
Jun 2020
Primary outcomePrimary: Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) — 0.053; 0.370 logMAR — p=< 0.0001
Summary
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) |
0.053; 0.370 | < 0.0001 sig |
| PRIMARY Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve |
2.3; 0.8 | — |
| SECONDARY Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm |
0.151; 0.466 | <0.0001 sig |
| SECONDARY Overall Spectacle Wear |
63.3; 7.6 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Minimum 22 years of age
- Bilateral cataracts for which posterior chamber IOL implantation has been planned
- Corneal astigmatism:
- Normal corneal topography
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
- Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- Ability to understand and respond to a questionnaire in English
Exclusion Criteria
- Irregular corneal astigmatism
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Poorly-controlled diabetes
- Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- Desire for monovision correction
Data sourced from ClinicalTrials.gov (NCT03500198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.