DRKS00005742
Completed
未知
Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL (Intraocular lens) - EROV-108-COMP
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- h25
- Sponsor
- Abbott Medical Optics Inc.
- Enrollment
- 147
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Minimum 22 years of age
- •· Planned natural lens replacement with posterior chamber IOL implantation
- •· Visual potential of 20/25 or better in the operative eye following natural lens
- •replacement with an IOL
- •· Normal corneal topography
- •· Clear intraocular media other than cataract in each eye
- •· Availability, willingness, sufficient cognitive awareness to comply with examination
- •· Ability to sign informed consent
Exclusion Criteria
- •· Requiring an intraocular lens power outside the available range of \+16\.0 D to
- •· Patients with recurrent severe anterior or posterior segment inflammation or uveitis
- •of unknown etiology, or any disease producing an inflammatory reaction in the eye
- •· Patients in whom the intraocular lens may affect the ability to observe, diagnose or
- •treat posterior segment diseases
- •· Expected surgical difficulties at the time of cataract extraction, which may increase
- •the potential for complications (e.g., persistent bleeding, significant iris damage,
- •uncontrolled positive pressure or significant vitreous prolapse or loss)
- •· A compromised eye due to previous trauma or developmental defects in which
- •appropriate support of the IOL is not possible
Outcomes
Primary Outcomes
Not specified
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