CLinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoratio

Not Applicable

Active, not recruiting

• Conditions: Cataract; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12617000708358
• Lead Sponsor: PowerVision

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-17
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary effectiveness objective for FluidVision lens will be assessed by comparison of, Monocular distance corrected near visual acuity (DCNVA) at 40 cm between FluidVision lens and trifocal control lens (Alcon PanOptix IQ) at 100% contrast as assessed with the M&S Technologies Clinical Trial Suite System (electronic ETDRS charts).[Month 6]