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Clinical Trials/NL-OMON35080
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

Sponsor
AMO Groningen BV

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