Trial document




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  DRKS00005696

Trial Description

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Title

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

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Trial Acronym

AIOL-2009-1

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00005696
  •   2014/05/06
  •   2014/01/28
  •   no
  •   Approved
  •   MV-064/2009, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   NCT02049567  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   H25 -  Senile cataract
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Interventions/Observational Groups

  •   Experimental: Implant

    FluidVision Lens shall be surgically implanted to restore accommodative vision.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Objective accommodative amplitude after 6 months using an auto refractometer.

Best corrected distance visual acuity of logMAR of 0.3 or better.

Rates of serious adverse events at 6 months.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   South Africa
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/01/10
  •   115
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional 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.

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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).

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Addresses

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    • PowerVision, Inc.
    • Ms.  OD  Priya  Janakiraman 
    • 260 Harbor Blvd
    • 94070  Belmont
    • United States
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    • PowerVision, Inc.
    • Mr.  M.D.  Raymund  Angeles 
    • 260 Harbor Blvd
    • 94002  Belmont
    • United States
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    • Department of Ophthalmology Ruprecht-Karls University Heidelberg
    • Mr.  Prof. Dr. med  Gerd  Auffarth 
    • INF 400
    • D-69120  Baden-Württemberg
    • Germany
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    • PowerVision, Inc.
    • Ms.  OD  Priya  Janakiraman 
    • 260 Harbor Blvd
    • 94070  Belmont
    • United States
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Sources of Monetary or Material Support

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    • PowerVision, Inc.
    • 260 Harbor Boulevard
    • 94070  Belmont
    • United States
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    •   650.620.9948
    •   650.620.4607
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.