NL-OMON35740
Completed
Not Applicable
A PROSPECTIVE MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ACUFOCUS* CORNEAL INLAY ACI 7000PDT IMPLANTED INTRA-STROMALLY FOR MODIFIED MONOVISION IN PRESBYOPIC SUBJECTS - ACU-P10-020B (AcuFocus, ACI 7000PDT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- MODIFIED MONOVISION
- Sponsor
- AcuFocus, Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects must sign and be given a copy of the written Informed Consent form.
- •2\. Subjects must be emmetropes needing a magnitude of \+1\.00D to \+2\.50D of reading
- •3\. Subjects must have uncorrected near visual acuity worse than 20/40 and better
- •than 20/100 in the eye to be implanted.
- •4\. Subjects must have distance visual acuity correctable to at least 20/20 in both eyes.
- •5\. Subjects must have a preoperative spherical equivalent of plano defined as \+0\.50D to \-0\.75D with no more than 0\.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.
- •6\. Subjects must have a stable refraction twelve months prior to ACI implantation: i.e.
- •MRSE within 0\.50D over prior twelve months as determined by subject history.
- •7\. Subjects who are soft contact lens wearers must discontinue their contact lenses for
- •at least one week prior to ACI pre\-operative examination.
Exclusion Criteria
- •1\. Subjects with a difference of \>1\.00D between the spherical equivalent manifest
- •refraction and the spherical equivalent cycloplegic refraction.
- •2\. Subjects with anterior segment pathology, including cataracts, in the eye to be
- •3\. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any
- •corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal
- •erosion, etc.) in the eye to be implanted.
- •4\. Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus
- •suspect) or keratoectasia in the eye to be implanted.
- •5\. Subjects with dry eye as determined by objective testing; anesthetized Schirmer\*s
- •test result \<10 mm or a tear break\-up time (TBUT) less than 10 seconds are
Outcomes
Primary Outcomes
Not specified
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