Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
1 other identifier
interventional
750
1 country
1
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, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
January 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
May 14, 2025
May 1, 2025
8.7 years
January 7, 2019
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 or PODEYE 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°)
7 months
Secondary Outcomes (5)
Decentration
7 months
Tilt
7 months
Anterior chamber depth
1 month
Best corrected visual acuity (BCVA)
7 months
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
7 months
Study Arms (4)
0°
EXPERIMENTALImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
45°
EXPERIMENTALImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
90°
EXPERIMENTALImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
135°
EXPERIMENTALImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
Interventions
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 and PODEYE Toric IOL on the axis according to the steep meridian of the cornea
Eligibility Criteria
You may qualify if:
- 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 and PODEYE Toric)
- Pupil dilation \>5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna Allgemeines Krankenhaus
Vienna, Vienna, 1090, Austria
Related Publications (1)
Schartmuller D, Lisy M, Mahnert N, Schranz M, Danzinger V, Schwarzenbacher L, Pieh S, Abela-Formanek C, Leydolt C, Menapace R. Rotational stability and refractive outcomes of a new hydrophobic acrylic toric intraocular lens. Eye Vis (Lond). 2024 Jul 2;11(1):25. doi: 10.1186/s40662-024-00393-2.
PMID: 38951940DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rupert Menapace, Prof.Dr.
Medical University Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ao.Univ.Prof.Dr. Rupert Menapace
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 15, 2019
Study Start
January 21, 2019
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share