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Clinical Trials/NL-OMON37851
NL-OMON37851
Completed
Phase 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 enrollmentTBD
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Conditionsbilateral cataractpresbyopia10047518

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
bilateral cataract
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
28
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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