None listed
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the investigational FluidVision (registered trademark) MX Accommodating Intraocular Lens (AIOL) in providing distance, intermediate, and near vision as compared to a trifocal IOL (Alcon PanOptix IQ), in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation.
Interventions
The purpose of this investigation is to compare the safety and effectiveness of the investigational AIOL to the approved commercially available trifocal IOL (Alcon PanOptix IQ) (active control) in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation.
Patients diagnosed with cataracts in both eyes, who require bilateral cataract extraction by phacoemulsification and are eligible for bilateral IOL implantation.
The study is a prospective, randomized, cont
The purpose of this investigation is to compare the safety and effectiveness of the investigational AIOL to the approved commercially available trifocal IOL (Alcon PanOptix IQ) (active control) in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation. Patients diagnosed with cataracts in both eyes, who require bilateral cataract extraction by phacoemulsification and are eligible for bilateral IOL implantation. The study is a prospective, randomized, controlled, bilateral, multinational, subject and assessor-blinded design. The randomization employs a 1:1 ratio for subjects to receive either the investigational AIOL or a commercially available trifocal IOL (Alcon PanOptix IQ) (active control). Subjects will be randomly assigned to receive bilateral implantation of the Acrysof® IQ PanOptix Trifocal IOL (Model TFNT00, Alcon, TX, USA) with an Alcon qualified delivery system or the investigational FluidVision MX AIOL (PowerVision, CA, USA) using the PowerJect Injector System following standard cataract extraction. The trifocal lens (Alcon PanOptix IQ) restores vision at more than one distance, by splitting or stretching the light entering the eye. The investigational AIOL is designed to use the eye’s natural forces to change the shape and power of the lens, producing a change in lens power when needed. Randomization will be stratified by site and both arms of the study will enrol the same number of subjects. Eligible subjects must be able to undergo the second eye surgery using the same device as the first eye treatment. The second surgery will occur after the 1 Week follow up on the first eye surgery is complete. Subjects will be followed at 1 day, 1 week, and 1, 3, 6, and 12 months post-surgery. The intervention is intended to be a single visit outpatient surgery with follow-up visits, also at the the study’s affiliated clinic(s), at 1 day, 1 week, 1 month, 3, 6, and 12 months post-surgery, for each treated eye. The study team member assigned to perform visual acuity assessments at each follow-up visit will be masked to the type of IOL that the subject receives. The subject will also be masked to the type of IOL implant used during surgery. The implanting investigator performing the procedure will not be masked to the treatment assignment.
Sponsors
PowerVision
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 50 years of age; 2. Willing and able to comply with schedule for follow-up visits; 3. Able to read and understand the Informed Consent Form and Patient Information materials; 4. Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction 5. Corrected distance visual acuity is equal to or worse than 20/40 either with or without a glare source present OR presence of visually significant lens opacity; 6. Predicted corrected distance visual acuity in both eyes to be 20/32 or better after cataract removal and IOL implantation as determined by potential acuity meter (PAM) or other potential vision tests; 7. Less than or equal to 1.0 diopter (D) of preoperative or predicted post-operative corneal astigmatism; 8. Clear intraocular media other than cataract; 9. Preoperative central endothelial cell density of 2200 cells/mm2 or more; 10. Eligible for LASIK procedure or other corneal refraction correction procedure; 11. Willing to wear contact lenses and physically capable of wearing them per investigator examination 12. Able to undergo second eye surgery within 14 days after the first eye surgery.
Exclusion criteria
1. Subject is a member of a vulnerable population as defined in ISO 14155; 2. Current use of medications that may affect accommodation; 3. Current or historic use of systemic medications that may confound the outcome or increase the risk to the subject; 4. Sensitivity to planned study medications; 5. Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes; 6. Has systemic disease that could increase the operative risk or confound the outcome; 7. Ocular conditions that may predispose for future complications (e.g. anterior segment pathology including potentially occludable angles, corneal dystrophy, ocular inflammation); 8. Monocular patient or significant permanent visual function loss in one eye; 9. Previous refractive, intraocular or corneal surgery in either eye; 10. Diagnosed degenerative visual disorders that are predicted to cause future corrected distance visual acuity worse than 20/32; 11. Conditions that increase the risk of zonular rupture during procedure; 12. Simultaneous participation in other ophthalmic drug or device clinical trial; 13. Baseline dilated pupil size less than 8 mm in diameter; 14. Anterior Chamber Depth (ACD) less than 2.8 mm, based on IOL Master; 15. Grade 4 cataract in either eye, as assessed per the Quick Reference Guide (QRG)-8 published by the American Optometric Association; 16. Subject has any other condition(s), disease(s) or habit(s) that would interfere with completion of the study and follow-up visits, increase the risk(s) of the cataract and/or IOL procedure, or in the physician’s judgement, would interfere with compliance to the study or adversely impact study outcomes. 17. Subject randomized to AIOL with ocular dimensions not within range of manufacturer’s fitting algorithm. Intraoperative Exclusion Criteria 18. Do not have an intact capsulorhexis and posterior capsule at the time of cataract extraction and lens implantation; 19. Floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction; 20. Posterior capsules that are found to be thin, brittle or fibrosed; 21. Decentered capsulorhexis of >1.0 mm in relation to the limbus; 22. Posterior capsular opacity observed after cataract extraction; 23. Complicated cataract surgery that prevents attempted implantation of the (A)IOL. Additional Intraoperative Exclusion Criteria for the FluidVision AIOL 24. Unable to attain and maintain a dilated pupil size =7 mm in diameter; 25. Capsulorhexis size of less than 6.0 mm or greater than 6.5 mm.
Outcome results
None listed