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Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex (RayAXClaroNaro)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803852
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

Brief Summary:
The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, two different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months.

Condition or disease Intervention/treatment Phase
Age Related Cataracts Device: Intraocular Lens Implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study involves 3 different groups. One investigating the RayOne IOL and the other investigating the Clareon IOL. Those 2 groups will be evaluated separately.

Alcon Clareon group: 120 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 120 eyes

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: 0°
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex on axis 0°
Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex into the capsular bag using an injector, after removing of the human cristalline lens.

Experimental: 45°
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex on axis 45°
Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex into the capsular bag using an injector, after removing of the human cristalline lens.

Experimental: 90°
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex on axis 90°
Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex into the capsular bag using an injector, after removing of the human cristalline lens.

Experimental: 135°
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex on axis 135°
Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex into the capsular bag using an injector, after removing of the human cristalline lens.




Primary Outcome Measures :
  1. Change of axial intraocular lens position [ Time Frame: 7 months ]
    Change in axis position of an intraocular lens Rayner RayOne or Alcon Clareon from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)


Secondary Outcome Measures :
  1. Decentration [ Time Frame: 7 months ]
    Decentration of the intraocular lens Rayner RayOne or Alcon Clareon will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"

  2. Tilt [ Time Frame: 7 months ]
    Tilt of the intraocular lens Rayner RayOne or Alcon Clareon will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"

  3. Anterior chamber depth [ Time Frame: 1 month ]
    The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Alcon Clareon will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter

  4. Best corrected visual acuity (BCVA) [ Time Frame: 7 months ]
    BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)



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:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
  • Age: 45 to 95
  • Need for spherical IOL correction between 10.00 and 30.00 D
  • Preoperative pupil dilation in mydriasis ≥ 7.0 mm

Exclusion Criteria:

  • Preceding ocular surgery or trauma

    • Recurrent intraocular inflammation of unknown etiology
    • Uncontrolled glaucoma
    • Uncontrolled systemic or ocular disease
    • Blind fellow eye
    • Microphthalmus
    • Corneal abnormality (Corneal scaring)
    • History of uveitis/iritis
    • Iris neovascularization
    • Proliferative diabetic retinopathy
    • Pregnancy
    • Lactation
    • Females of childbearing age will be asked if pregnancy is possible

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): NCT03803852


Contacts
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Contact: Rupert Menapace, Prof.Dr. 0043-1-40400 ext - 66300 rupert.menapace@meduniwien.ac.at
Contact: Daniel Schartmueller, Dr. 0043-1-40400 ext 79450 daniel.schartmueller@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Allgemeines Krankenhaus Recruiting
Vienna, Austria, 1090
Contact: Rupert Menapace, Prof.    014040066300    rupert.menapace@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Rupert Menapace, Prof.Dr. Medical University Vienna
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Responsible Party: Rupert Menapace, Ao.Univ.Prof.Dr. Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03803852    
Other Study ID Numbers: 1978/2018
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases