A Prospective, multicenter, randomized, parallel-controlled, evaluator masked, non- inferiority clinical trial to evaluate the effectiveness and safety of multifocal IOLs (INTENSITY SL) for vision correction in aphakia patients
Single Center Post-Market Clinical Follow-Up (PMCF) Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL
The goal of this clinical trial is to compare the visual performance between Intensity SL IOL and Panoptix IOL in men and women diagnosed with cataract who require cataract surgery procedure that meet the inclusion criteria and provide written informed consent will be enrolled in the study.
The main questions it aims to answer are:
1. To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation.
2. To show non-inferiority in the Defocus Curve measurement
3. To show non-inferiority in Contrast Sensitivity measurement
4. To show non-inferiority in patient satisfaction
Participants will attend a total of 10 study visits: 1 preoperative visit, 2 operations and 7 postoperative visits.
Intensity Lenses Post Operation Standard of Care Visits - Data Collection.
Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.
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