CataractNCT06607848
Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses
A study testing Low-Add EDOF IOL and EDOF IOL in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Low-Add EDOF IOL and EDOF IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jul 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
- Written informed consent prior to surgery
Who cannot join
- Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- Corneal decompensation or corneal endothelial cell insufficiency
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, Austria, 1140
Johannes Zeilinger, MD, 01 91021 57564, office@viros.at
Manuel Ruiss, Mac, 01 91021 57564, office@viros.at
About this study
Official title: Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
Read the detailed description
Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.
Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.
The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.
The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo\&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.
The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.
- Conditions
- Cataract
- Being tested
- Low-Add EDOF IOL, EDOF IOL
- Keywords
- EDOF IOL, presbyopia-correction, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Add EDOF IOLDevice
Acunex Vario AN6V
EDOF IOLDevice
PureSee EDOF IOL
| Study group | Role | What they receive |
|---|---|---|
| Acunex Vario AN6V | Experimental | Patients will receive the Acunex IOL during cataract surgery Receives: Device: Low-Add EDOF IOL |
| PureSee | Experimental | Patients will receive the PureSee IOL during cataract surgery Receives: Device: EDOF IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance corrected visual acuity for intermediate distance
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Measured: 6 months
Secondary outcomes (7)
Uncorrected visual acuity for intermediate distance
Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Measured: 6 months
Uncorrected and distance corrected visual acuity for far distance
Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts
Measured: 6 months
Uncorrected and distance corrected visual acuity for near distance
Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts
Measured: 6 months
Defocus curve assessment
Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart
Measured: 6 months
Halometry
Potential halos will be assessed using the Aston Halometer App provided on a Tablet at 2 m
Measured: 6 months
Contrast sensitivity
Contrast sensitivity will be tested using the Optec device
Measured: 6 months
Subjective rating of dysphotopsia
Dysphotopsia will be subjectively rated by the patients using a questionnaire and a visual analogue scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start29 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Univ. Prof. Prim. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607848
- Sponsor's protocol ID
- Vario vs. PureSee
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
- ClinicalTrials.gov ID
- NCT06607848
- Acronym / sponsor ID
- Vario vs. PureSee
- Conditions
- Cataract
- Keywords
- EDOF IOL, presbyopia-correction, Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
Detailed description
Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.
Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.
The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.
The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo\&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.
The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acunex Vario AN6V | Experimental | Device: Low-Add EDOF IOLPatients will receive the Acunex IOL during cataract surgery |
| PureSee | Experimental | Device: EDOF IOLPatients will receive the PureSee IOL during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity \> 0.05
- For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
Key exclusion criteria (7 listed)
- Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
- Corneal decompensation or corneal endothelial cell insufficiency
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
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 |
|---|---|---|
| Low-Add EDOF IOLAcunex Vario AN6V | Device | Acunex Vario AN6V |
| EDOF IOLPureSee EDOF IOL | Device | PureSee |
Primary outcome
Distance corrected visual acuity for intermediate distance
Time frame: 6 months
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
7 secondary outcomes
Uncorrected visual acuity for intermediate distance
Time frame: 6 months
Uncorrected and distance corrected visual acuity for far distance
Time frame: 6 months
Uncorrected and distance corrected visual acuity for near distance
Time frame: 6 months
Defocus curve assessment
Time frame: 6 months
Halometry
Time frame: 6 months
Contrast sensitivity
Time frame: 6 months
Subjective rating of dysphotopsia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- 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. This study is not recruiting at the moment.
Oliver Findl, Univ. Prof. Prim. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery (VIROS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Add EDOF IOL and EDOF IOL in people with Cataract, run by Vienna Institute for Research in Ocular Surgery 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Zeilinger, MD (01 91021 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance corrected visual acuity for intermediate distance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.