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Evaluation of the FluidVisionTM AIOL With an Improved Injector

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418871
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
PowerVision

Brief Summary:
The objective of this study is to evaluate the clinical outcomes of an accommodating intraocular lens (AIOL) designed to provide distance, intermediate, and near vision in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.

Condition or disease Intervention/treatment Phase
Presbyopia Device: FluidVisionTM AIOL with an improved injector Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the FluidVisionTM Accommodating Intraocular Lens With an Improved Injector System
Actual Study Start Date : March 13, 2015
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Arm Intervention/treatment
Experimental: Single arm Device: FluidVisionTM AIOL with an improved injector



Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 3 months ]
  2. Visual Acuity [ Time Frame: 6 months ]
  3. Visual Acuity [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
  • best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
  • predicted best corrected distance visual acuity to be 20/30 or better after cataract removal and AIOL implantation as determined by potential acuity meter (PAM) or other potential vision tests or surgeon estimation on both eyes;
  • ≤1.0 D of preoperative keratometric astigmatism (first operative eye only);
  • clear intraocular media other than cataract;
  • preoperative central endothelial cell density of 2200 cells/mm2 or more;
  • at least 50 years of age;
  • willing and able to comply with schedule for follow-up visits for 36 months after surgery;
  • calculated AIOL power within the range of investigational device;
  • provide written informed consent.

Exclusion Criteria:

  • vulnerable population as defined in ISO 14155 (e.g. individuals with lack of autonomy due to mental disability, persons in nursing homes, and children)
  • taking medications that may affect accommodation (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
  • systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, uncontrolled diabetes as demonstrated by HbA1c values);
  • taking systemic medications that may confound the outcome or increase the risk to the subject, i.e. tamsulosin hydrochloride (Flomax) or other medications with similar side effects;
  • ocular conditions that may predispose for future complications (e.g. anterior segment pathology including glaucoma or potentially occludable angles, corneal dystrophy, ocular inflammation);
  • monocular patient or presence of significant permanent visual function loss in fellow eye;
  • previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
  • pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
  • diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future best corrected distance visual acuity worse than 20/30;
  • floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction;
  • conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
  • sensitivity to planned study medications;
  • simultaneous participation in other ophthalmic drug or device clinical trial;
  • does not have an intact capsulorhexis and posterior capsule at the time of cataract extraction and lens implantation;
  • baseline dilated pupil size <8mm in diameter;
  • ACD based on IOL Master <2.8 mm;
  • corneal diameter <10 mm in any meridian;
  • capsulorhexis size of <5.5 mm or >6.0 mm;
  • not within range of manufacturer's fitting algorithm
  • decentered capsulorhexis of >1.0 mm in relation to the limbus;
  • posterior capsular opacity observed after cataract extraction;
  • complicated cataract surgery that prevents attempted implantation of the AIOL (e.g.; pupillary constriction, poor visibility due to corneal edema).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418871


Locations
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Hungary
Peterfry Hospital
Budapest, Hungary
Semmelweiss University
Budapest, Hungary
South Africa
John Hill Eye Laser Centre
Claremont, Cape Town, South Africa, 2001
Visiomed Laser Centre
Northcliff, Johannesburg, South Africa, 2001
Optimed Eye and Laser Centre
Queenswood, Pretoria, South Africa, 2001
Somerset Eye Clinic
Somerset West, South Africa
Sponsors and Collaborators
PowerVision
Investigators
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Study Director: Trial Director PowerVision

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Responsible Party: PowerVision
ClinicalTrials.gov Identifier: NCT02418871     History of Changes
Other Study ID Numbers: AIOL-2015-1
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by PowerVision:
cataract
presbyopia
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases