Age Related CataractsNCT03803852
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
A study testing Intraocular Lens Implantation in people with Age Related Cataracts and Astigmatism, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Age Related Cataracts, Astigmatism
- What is being tested?
- Intraocular Lens Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jan 2019to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Preceding ocular surgery or trauma
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
- Microphthalmus
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna Allgemeines Krankenhaus
Vienna, State of Vienna, 1090
Rupert Menapace, Prof., 014040066300, rupert.menapace@meduniwien.ac.at
About this study
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
- Conditions
- Age Related Cataracts, Astigmatism
- Being tested
- Intraocular Lens Implantation
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Lens ImplantationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 0° | Experimental | Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0° Receives: Device: Intraocular Lens Implantation |
| 45° | Experimental | Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45° Receives: Device: Intraocular Lens Implantation |
| 90° | Experimental | Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90° Receives: Device: Intraocular Lens Implantation |
| 135° | Experimental | Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135° Receives: Device: Intraocular Lens Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°)
Measured: 7 months
Secondary outcomes (5)
Decentration
Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"
Measured: 7 months
Tilt
Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Measured: 7 months
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 or PODEYE Toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter
Measured: 1 month
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)
Measured: 7 months
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
Uncorrected Intermediate Visual Acuity mono or bilateral
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start21 Jan 2019
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 PODEYE Toric: 120 eyes
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, Prof.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803852
- Sponsor's protocol ID
- 1978/2018
- Status last verified
- May 2025
- First submitted
- 7 Jan 2019
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lisy M, Danzinger V, Schranz M, Mahnert N, Abela-Formanek C, Leydolt C, Menapace R, Schartmuller D. Assessing postoperative toric intraocular lens rotation: comparative analysis. J Cataract Refract Surg. 2025 Mar 1;51(3):196-203. doi: 10.1097/j.jcrs.0000000000001585.
PubMed 39602338Schartmuller 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.
PubMed 38951940
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
- ClinicalTrials.gov ID
- NCT03803852
- Acronym / sponsor ID
- 1978/2018
- Conditions
- Age Related Cataracts, Astigmatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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 PODEYE Toric: 120 eyes
| Arm | Type | Receives |
|---|---|---|
| 0° | Experimental | Device: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0° |
| 45° | Experimental | Device: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45° |
| 90° | Experimental | Device: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90° |
| 135° | Experimental | Device: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135° |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- Preceding ocular surgery or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular Lens ImplantationImplantation 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 | Device | 0°, 135°, 45°, 90° |
Primary outcome
Change of axial intraocular lens position
Time frame: 7 months
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°)
5 secondary outcomes
Decentration
Time frame: 7 months
Tilt
Time frame: 7 months
Anterior chamber depth
Time frame: 1 month
Best corrected visual acuity (BCVA)
Time frame: 7 months
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 39602338Lisy M, Danzinger V, Schranz M, Mahnert N, Abela-Formanek C, Leydolt C, Menapace R, Schartmuller D. Assessing postoperative toric intraocular lens rotation: comparative analysis. J Cataract Refract Surg. 2025 Mar 1;51(3):196-203. doi: 10.1097/j.jcrs.0000000000001585.
- Derived from this study: PubMed 38951940Schartmuller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rupert Menapace, Prof.Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular Lens Implantation in people with Age Related Cataracts and Astigmatism, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rupert Menapace, Prof.Dr. (0043-1-40400 ext. - 66300, rupert.menapace@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of axial intraocular lens position (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.