NL-OMON35080CompletedPhase 4
Pilot study to compare straylight perception in pseudophakic subjects with different intraocular lenses - Clear Multifocal Vision (CMV)
AMO Groningen BV0 sites15 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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 <16.0 or >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.
Investigators
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