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Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon Toric & Hoya Vivinex Impress & Hoya Nanex

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT03803852
Collaborator
(none)
510
Enrollment
1
Location
4
Arms
56.7
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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, three 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.

In the Alcon Clareon toric group, patients receive a toric IOL according to their preoperative astigmatism

Condition or Disease Intervention/Treatment Phase
  • Device: Intraocular Lens Implantation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
510 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study involves 4 different groups. All groups will be investigated seperately Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Hoya Nanex group: 130 eyesThe study involves 4 different groups. All groups will be investigated seperately Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Hoya Nanex group: 130 eyes
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon Toric & Hoya Vivinex Impress & Hoya Nanex
Actual Study Start Date :
Jan 21, 2019
Anticipated Primary Completion Date :
Jun 14, 2023
Anticipated Study Completion Date :
Oct 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0°

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°

Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea
Experimental: 45°

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°

Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea
Experimental: 90°

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°

Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea
Experimental: 135°

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°

Device: Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric IOL on the axis according to the steep meridian of the cornea

Outcome Measures

Primary Outcome Measures

  1. Change of axial intraocular lens position [7 months]

    Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric 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 [7 months]

    Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressfrom or Alcon Clareon toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"

  2. Tilt [7 months]

    Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"

  3. Anterior chamber depth [1 month]

    The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric 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) [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)

  5. UCIVA in the Alcon Clareon toric group [7 months]

    Uncorrected Intermediate Visual Acuity mono or bilateral

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)

  • Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)

  • Astigmatism of at least 1.0 Diopters (Alcon Clareon toric group)

  • Pupil dilation >5.5mm (Alcon Clareon toric group)

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Allgemeines Krankenhaus Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Rupert Menapace, Prof.Dr., Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 15, 2019
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract
Astigmatism

Study Results

No Results Posted as of May 17, 2022