straylight adverse optical effect
Conditions
Interventions
Implantation of two CE marked Multifocal Intra-ocular lenses after extraction
of the natural opacified lens.
Sponsors
AMO Groningen BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 or greater 2. Bilateral cataracts for which phacoemulsification cataract extraction and posterior chamber IOL implantation have been planned. 3. Visual potential in each eye of 0.8 (20/25 Snellen) or better as determined by surgeon*s estimation 4. Normal corneal topography with preoperative corneal astigmatism of 1.5 D or less (or the ability to manage astigmatism to 1.0 or less postoperatively by incision placement) 5. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Concurrent participation or participation during the last 30 days in any other clinical trial 2. Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated) 3. Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, diabetes, etc.) 4. Uncontrolled systemic or ocular disease 5. Irregular astigmatism 6. Requiring an intraocular lens 26.0 diopters 7. History of ocular trauma or prior ocular surgery 8. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies 9 10. Uncontrolled ocular hypertension or glaucomatous changes in the retina 11. Intraocular inflammation or recurrent ocular inflammatory condition 12. Known pathology that may potentially affect vision 13. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils) 14. Capsule or zonule abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, an eccentric anterior capsulorhexis, or posterior capsule defects 15. Retinal changes that may affect vision or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) 16. Planned moving or moving to another home address during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY CLINICAL STUDY ENDPOINTS: Pre- and postoperative stray light perception measured with the C-Quant (standard and with modified tube), Rostock Glare Perimeter, Double Pass System and a subject questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected and best corrected distance visual acuities (ETDRS 100% and 25% charts) • Capsular bag striae ratings • IOL Decentration/Tilt • Posterior capsule opacification (PCO) • Optical visual symptom incidence • Complication rates • Adverse event rates • Subjective subject questionnaire | — |
Countries
Netherlands
Outcome results
None listed