A COMPARATIVE CLINICAL EVALUATION OF A NEWTECNIS® PRESBYOPIA-CORRECTING INTRAOCULAR LENS AGAINST A TRIFOCAL INTRAOCULAR LENS
- Conditions
- H25H26Senile cataractOther cataract
- Registration Number
- DRKS00016732
- Lead Sponsor
- Johnson & Johnson Surgical Vision, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 205
Inclusion Criteria (all criteria apply to both eyes):
- Age 22 and older
- Bilateral cataracts or clear crystalline lenses for which posterior chamber IOL implantation has been planned
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 Snellen) or better
- Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
- Clear intraocular media other than cataract in each eye
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
- Written informed consent for participation in the study and data protection.
Exclusion Criteria (including device labeling, all criteria apply to both eyes):
- Require an intraocular lens power outside the available range of +14.0 to +26.0 D
- Irregular corneal astigmatism (as evaluated by topography)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 Snellen) during the study
- Inability to achieve keratometric stability for contact lens wearers, as described in Section 10.1 Preoperative Procedures
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Pupil abnormalities that may affect visual outcomes or increase risk to the subject
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 Snellen) during the study
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
- Use of systemic or ocular medications that, in the opinion of the investigator, may affect vision
- Prior, current, or anticipated use during the 12-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- Poorly-controlled diabetes or hypertension that, in the opinion of the investigator, may impact visual outcome or increase the risk to the subject
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- Known ocular disease or pathology that, in the opinion of the investigator,
o may affect visual acuity (e.g., ocular surface conditions)
o may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
o may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
- Concurrent participation or participation within 60 days prior to the preoperative visit in any other clinical trial
- Desire for monovision correction
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Percent of subjects who achieve binocular distance-corrected VA of 20/25 or better at far, intermediate, and near <br>- Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near <br>- Mean binocular DCNVA at 40 cm<br>- Mean binocular photopic and mesopic DCNVA at 33 cm<br>- Mean binocular best-corrected photopic low-contrast (25%) VA at far <br>- Mean binocular best-corrected mesopic VA at far<br>- Difference between lens groups in range of intermediate & near defocus VA (diopters of 0.2 logMAR or better from 1.0 to -3.5 D)<br><br>- Differences between lens groups in rates of questionnaire responses<br>
- Secondary Outcome Measures
Name Time Method Differences between lens groups in rates of questionnaire responses