Prospective, Non-randomized, Multicenter, Parallel group (55-75 subjects) Clinical Investigation of Extended Range of Vision (ERV) Intraocular Lenses, XRA03 and Toric series ZXT on Best-Corrected Distance Visual Acuity in Participants Requiring Bilateral Cataract Removal and Lens Replacement Sequentially In Both Eyes .

Abbott Medical Optics Inc0 个研究点目标入组 75 人开始时间: 2013年10月29日最近更新: 2020年1月13日

研究概览

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•1. Bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation are planned
•2. Visual potential of 6/7.5 Metric (20/25 Snellen) or better in each eye following cataract removal and IOL implantation
•3. Clear intraocular media other than cataract in each eye
•4. Normal corneal topography
•5. Subjects for ERV Model Series ZXT only:
•5.1 Preoperative corneal cylinder between 0.75 D and 3.62 D in both eyes and an AMO Toric calculation lens model recommendation of a ZCT lens equal to the study lens powers of ZXT150, ZXT225, ZXT300, or ZXT375, with a predicted spherical equivalent outcome of emmetropia (+/-0.25 D).

•1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
•2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
•3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
•4.Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses
•5. Use of systemic or ocular medications that may affect vision
•6. No irregular corneal astigmatism.
•7. Poorly-controlled diabetes
•8. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

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