Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric
Primary Purpose
Age Related Cataracts, Astigmatism
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Intraocular Lens Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Cataracts
Eligibility 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
- 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
Sites / Locations
- Medical University of Vienna Allgemeines KrankenhausRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
0°
45°
90°
135°
Arm Description
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
Outcomes
Primary Outcome Measures
Change of axial intraocular lens position
Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV 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
Decentration
Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"
Tilt
Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Anterior chamber depth
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 or Rayner RayOne EMV toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter
Best corrected visual acuity (BCVA)
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)
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
Uncorrected Intermediate Visual Acuity mono or bilateral
Full Information
NCT ID
NCT03803852
First Posted
January 7, 2019
Last Updated
October 16, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03803852
Brief Title
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric
Official Title
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
June 14, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 and RayOne EMV toric groups, patients receive a toric IOL according to their preoperative astigmatism
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study involves 5 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 Rayner RayOne EMV toric group: 120 eyes
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0°
Arm Type
Experimental
Arm Description
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
Arm Title
45°
Arm Type
Experimental
Arm Description
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
Arm Title
90°
Arm Type
Experimental
Arm Description
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
Arm Title
135°
Arm Type
Experimental
Arm Description
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
Intervention Type
Device
Intervention Name(s)
Intraocular Lens Implantation
Intervention Description
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 and Rayner RayOne EMV toric IOL on the axis according to the steep meridian of the cornea
Primary Outcome Measure Information:
Title
Change of axial intraocular lens position
Description
Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV 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°)
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Decentration
Description
Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"
Time Frame
7 months
Title
Tilt
Description
Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Time Frame
7 months
Title
Anterior chamber depth
Description
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 or Rayner RayOne EMV toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter
Time Frame
1 month
Title
Best corrected visual acuity (BCVA)
Description
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)
Time Frame
7 months
Title
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
Description
Uncorrected Intermediate Visual Acuity mono or bilateral
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)
Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group)
Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)
Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups)
Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupert Menapace, Prof.Dr.
Phone
0043-1-40400
Ext
- 66300
Email
rupert.menapace@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Schartmueller, Dr.
Phone
0043-1-40400
Ext
79450
Email
daniel.schartmueller@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, Prof.Dr.
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna Allgemeines Krankenhaus
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, Prof.
Phone
014040066300
Email
rupert.menapace@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric
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