Cataract
Conditions
Interventions
Eye surgery with removal of the original lens and replacement by an intraocular
lens.
Sponsors
Alcon Laboratories
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults, 22 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts 2. Able to comprehend and willing to sign an IRB/IEC approved statement of informed consent and complete all required post-implantation visits 3. Planned small incision cataract removal surgery 4. Calculated lens power is within the available range (see Table 11-1 for the available range of lens powers for this study) 5. Subjects for whom postoperative emmetropia is planned (defined as 0.00± 0.50 D spherical equivalent) in both eyes 6. Preoperative BCDVA worse than 0.2 logMAR in at least one eye Potential post-implantation visual acuity of 0.2 logMAR or better in both eyes based on Investigator expert medical opinion
Exclusion criteria
Exclusion criteria: 1. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than Nd:YAG capsulotomy) 2. Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of the subjects* participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions) 3. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial, stromal, or endothelial dystrophy), inflammation or edema per the Investigator*s expert medical opinion (Note: Conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded.) 4. Amblyopia 5. Previous corneal transplant 6. Extremely shallow anterior chamber (* 2.5 mm), not due to swollen cataract 7. Any recurrent severe anterior or posterior segment inflammation of any etiology, and or history of any disease producing an intraocular inflammatory reaction 8. Rubella, congenital, traumatic, or complicated cataracts 9. Ocular conditions where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology) 10. Iris neovascularization 11. Glaucoma (uncontrolled or controlled with medication) 12. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha1A adrenoceptor (eg, Flomax (tamsulosin HCL), Hytrin, or Cardura) that in the opinion of the Investigator would potentially require mechanical or surgical manipulation to enlarge the pupil 13. Subjects with diagnosed degenerative eye disorders, such as but not limited to, pseudoexfoliation 14. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes. Note: Including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration 15. Optic nerve atrophy 16. Subjects who are expected to require retinal laser treatment 17. Subjects with diagnosed congenital ocular disorders, such as but not limited to, aniridia or microphthalmia 18. Pregnancy or lactation current or planned during the course of the study 19. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation 20. Any other additional procedures during the cataract removal and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior rupture, with vitreous loss, zonular dehiscence that may make the IOL implant less stable 21. Uncontrolled intraocular pressure 22. Significant anterior chamber bleeding 23. Excessive iris mobility 24. Mechanical or surgical intervention required to manipulate the pupil Note: Pupil size must be 4.5mm or larger just prior to implantation 25. Any capsulorhexis other than continuous curvilinear capsulorhexis (eg, no anterior radial inconsistencies in the capsulorhexis such as anterior capsular tears or any areas of *can-opener* capsulotomy) 26. Unrecognized (pre-existing but discovered during surgery) ocular conditions or complications in which the IOL positio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary analysis set for effectiveness analyses will be the All-Implanted Analysis Set (AAS). AAS includes all eyes with successful test article implantation. Additional supportive analyses may be conducted using the Best-Case Analysis Set (BAS). BAS includes all eyes successfully implanted with the test article that had no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors. The Safety Analysis Set will include all eyes with attempted implantation with the test article (successful or aborted after contact with the eye) and will be used for the safety analyses. The primary effectiveness objective is to demonstrate that the one-sided exact 95% upper confidence limit for the percentage of subjects with monocular best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better at 3 years (Visit 7A) is not worse than SPE rate of 92.5% for AAS (as reported in EN ISO 11979-7:2014). The number and percentages of subjects with BCDVA of 0.3 logMAR or better at 3 years post-implantation (Visit 7A) will be summarized along with the corresponding two-sided exact 95% confidence interval. Three interim analyses summarizing the effectiveness and safety outcomes will be conducted when all subjects complete visits 4A, 5A, and 6A to support the study publication plan. Primary Effectiveness Endpoint Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 3 years post-implantation (Visit 7A) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Effectiveness Endpoints * Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 1 year post-implantation (Visit 5A) * Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years post-implantation (Visit 6A) * UCDVA at 1 year (Visit 5A) post-implantation * UCDVA at 2 years (Visit 6A) post-implantation * UCDVA at 3 years (Visit 7A) post-implantation Exploratory Effectiveness Endpoints * Manifest refraction at 1 year post-implantation (Visit 5A) * Manifest refraction at 2 years post-implantation (Visit 6A) * Manifest refraction at 3 years post-implantation (Visit 7A) * Percentage of eyes having Nd:YAG capsulotomy at 1 year (Visit 5A) * Percentage of eyes having Nd:YAG capsulotomy at 2 years (Visit 6A) * Percentage of eyes having Nd:YAG capsulotomy at 3 years (Visit 7A) * Glistenings at 1 month post-implantation (Visit 3A) * Glistenings at 6 months post-implantation (Visit 4A) * Glistenings at 1 year post-implantation (Visit 5A) * Glistenings at 2 years post-implantation (Visit 6A) * Glistenings at 3 years post-implantation (Visit 7A) | — |
Countries
Netherlands
Outcome results
None listed