NL-OMON37851CompletedPhase 4
A randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs - Presbyopia-correcting multifocal IOLs
Medisch Universitair Ziekenhuis Maastricht0 sites28 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •*Bilateral cataract
- •*Less than 1.00 diopters of corneal astigmatism in both eyes
- •*Fulfill the recommendations in the *Warnings* and *Precautions* sections of the AcrySof ReSTOR and FineVision package inserts*
- •*Age 42 years or older
- •*Expected postoperative logMAR +0.3 or better
- •*Availability to undergo second eye surgery within 2 weeks of the first eye surgery
- •*Willing and able to comply with scheduled visits and other study procedures
- •*Signed informed consent
Exclusion Criteria
- •*Planned multiple procedures, including LRI, during cataract/IOL implantation surgery
- •*Previous corneal surgery and/or reshaping
- •*Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
- •*History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •*Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen)
- •*Glaucoma related extensive visual field loss
- •*Extensive Diabetic macular disease
- •*Suturing of incision required at time of surgery
- •*Complications during surgery of the first eye.
Investigators
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