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Evaluation of the FluidVision Accommodating Lens (AIOL-2009-1)

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: NCT02049567
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
PowerVision

Brief Summary:

Traditional lenses for cataract patients are monofocal, meaning they offer clear distance vision, but that patients must wear eyeglasses or contact lenses in order to see clearly things that are close to them, such as a newspaper.

The FluidVision™ lens that is being tested in this study is designed to allow patients to see far objects as clearly as with a regular lens, and also to see near objects more clearly than with a regular lens.


Condition or disease Intervention/treatment Phase
Presbyopia Device: FluidVision Lens Not Applicable

Detailed Description:
The FluidVision lens is an IOL that utilizes the eye's natural accommodative forces to reshape the anterior surface of the lens to change optical power. It does this by using a proprietary hydraulic mechanism to drive fluid from the periphery of the device to the central lens portion and back again, changing the curvature of the lens surfaces and facilitating accommodation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
Actual Study Start Date : January 6, 2014
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 6, 2017

Arm Intervention/treatment
Experimental: FluidVision Lens
Single arm implantation of an accomodating intraocular lens
Device: FluidVision Lens
Intraocular lens designed to restore visual function at all distances.




Primary Outcome Measures :
  1. Objective accommodative amplitude [ Time Frame: 6 months ]
  2. Best corrected distance visual acuity of logMAR of 0.3 or better [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Rates of adverse events. [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Patients must be eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction.
  2. Patients should have a best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester)
  3. Patients predicted best corrected distance visual acuity must be 20/40 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.
  4. Patients must have ≤1.0 D of preoperative keratometric astigmatism.
  5. Patients must have clear intraocular media other than cataract.
  6. Patients must have a preoperative endothelial cell density of 2200 cells/mm2 or more.
  7. Patients must be at least 50 years of age.
  8. Patients must be willing and able to comply with schedule for follow-up visits for thirty six months after surgery.
  9. Patients must have a calculated AIOL power within the range of the investigational device;
  10. Patients must provide written informed consent.

Exclusion Criteria:

  1. Patients must not be 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).
  2. Patients must not have systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes).
  3. Patients must not have 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.
  4. Patients must not have ocular conditions that may predispose for future complications (e.g. anterior segment pathology including glaucoma or potentially occludable angles, corneal dystrophy, ocular inflammation, poor pupil dilation).
  5. Patients must not have previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
  6. Patients must not be pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
  7. Patients must not have degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
  8. Patients must not have 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).
  9. Patients must not have sensitivity to planned study medications.
  10. Patients must not be simultaneously participating in other ophthalmic drug or device clinical trial.
  11. Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract extraction and lens implantation.
  12. Patients who have floppy/weak zonules, incomplete zonules or zonular rupture during cataract extraction.
  13. Patients who have a capsulorhexis size of <5.5 mm or >6.0 mm.
  14. Patients who have a decentered capsulorhexis of >1.0 mm in relation to the limbus.
  15. Patients with posterior capsular opacity observed after cataract extraction.
  16. Patients with complicated cataract surgery or damage to AIOL that prevents 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): NCT02049567


Locations
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Germany
Department of Ophthalmology Ruprecht-Karls University Heidelberg
Heidelberg, Baden-Württemberg, Germany, D-69120
Charlottenklinik fuer Augenheilkunde
Stuttgart, Baden-Württemberg, Germany, D-70176
Center for Vision Science Ruhr University Eye Hospital
Bochum, North Rhine-Westphalia, Germany, 44892
Augentagesklinik
Berlin, Germany, 10559
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
Sponsors and Collaborators
PowerVision
Investigators
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Study Director: Trial Director PowerVision

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Responsible Party: PowerVision
ClinicalTrials.gov Identifier: NCT02049567     History of Changes
Other Study ID Numbers: CTP01725
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 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