CataractNCT07262021
Visual Function of Enhanced Monofocal Intraocular Lenses
A study testing enhanced monofocal IOL in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- enhanced monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2025to 1 Nov 2027
- 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 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
- Axial length: 21.00-27.00mm
- Astigmatism < 1.0 dpt
- Normal findings in the medical history and physical examination
- Written informed consent prior to surgery
Who cannot join
- Reduced contrast vision, binocularity or stereoscopic vision (e.g. amblyopia, strabismus)
- 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
- Irregular astigmatism on corneal tomography
- Pronounced dry eye disease
- Nystagmus or pathologies that might affect patient's fixation
- Previous ocular surgery or trauma
- Persons who are pregnant or nursing
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
Vienna Institute for Research in Ocular Surgery
Vienna, 1140
Oliver Findl, Prim. Univ.-Prof. Dr., +43 1 91021 ext. 57564, office@viros.at
About this study
Official title: Comparison of Visual Function of Enhanced Monofocal Intraocular Lenses After Cataract Surgery
Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery
Read the detailed description
Cataracts remain the leading cause of preventable blindness in many developing countries. Over the past decades, cataract surgery has undergone significant advancements. With the development of refined surgical techniques, such as smaller incisions, and the introduction of advanced intraocular lens (IOL) technologies, the procedure has transformed into a refractive approach for visual rehabilitation. The primary goal is to achieve a high level of spectacle independence for patient.
Monofocal lenses are designed with a single fixed focal length and refractive power. While they provide excellent distance vision, patients still need glasses for intermediate and near vision. However, modern patients have increasingly high expectations, often seeking full independence from spectacles after cataract surgery. This growing demand has fueled ongoing research and innovation in the development of advanced IOLs. In contrast, enhanced monofocal IOLs offer optical properties that deliver good intermediate vision outcomes without the negative aspects of multifocal IOLs such as photic phenomena or loss in contrast vision.
The aim of the study is therefore to compare two refractive enhanced monofocal IOLs in an intra-individual approach.
60 eyes of 30 patients will be included into this study. After randomization one eye is implanted with the Art 25 IOL, whereas the other eye gets the Eyhance IOL. Follow-up visits will be 1 week and 3 months after the surgery.
- Conditions
- Cataract
- Being tested
- enhanced monofocal IOL
- Keywords
- Cataract, Cataract surgery, intraocular surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced monofocal IOLDevice
Art 25 IOL, enhanced monofocal IOL
enhanced monofocal IOLDevice
Eyhance IOL, enhanced monofocal IOL
| Study group | Role | What they receive |
|---|---|---|
| Art 25 IOL | Experimental | Patient will receive the Art 25 IOL during cataract surgery Receives: Device: enhanced monofocal IOL |
| Eyhance | Experimental | Patient will receive the Eyhance IOL during cataract surgery Receives: Device: enhanced monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-corrected intermediate visual acuity
The difference in distance-corrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs
Measured: 3 months
Secondary outcomes (5)
Uncorrected intermediate visual acuity
The difference in uncorrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs
Measured: 3 months
Corrected and uncorrected distance visual acuity
The difference in corrected and uncorrected distance visual acuity before and after surgery will be measured at 4 m and compared between the two different IOLs
Measured: 3 months
Corrected and uncorrected near visual acuity
The difference in corrected and uncorrected near visual acuity before and after surgery will be measured at 40 cm and compared between the two different IOLs
Measured: 3 months
Defocus curve
The difference in visual acuity assessed in the defocus curve before and after surgery and compared between the two different IOLs
Measured: 3 months
Contrast Sensitivity
The difference in contrast sensitivity between the two different IOLs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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, Prim. Univ.-Prof. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262021
- Sponsor's protocol ID
- Art25
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Function of Enhanced Monofocal Intraocular Lenses After Cataract Surgery
- ClinicalTrials.gov ID
- NCT07262021
- Acronym / sponsor ID
- Art25
- Conditions
- Cataract
- Keywords
- Cataract, Cataract surgery, intraocular surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 3 Dec 2025 (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.
Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery
Detailed description
Cataracts remain the leading cause of preventable blindness in many developing countries. Over the past decades, cataract surgery has undergone significant advancements. With the development of refined surgical techniques, such as smaller incisions, and the introduction of advanced intraocular lens (IOL) technologies, the procedure has transformed into a refractive approach for visual rehabilitation. The primary goal is to achieve a high level of spectacle independence for patient.
Monofocal lenses are designed with a single fixed focal length and refractive power. While they provide excellent distance vision, patients still need glasses for intermediate and near vision. However, modern patients have increasingly high expectations, often seeking full independence from spectacles after cataract surgery. This growing demand has fueled ongoing research and innovation in the development of advanced IOLs. In contrast, enhanced monofocal IOLs offer optical properties that deliver good intermediate vision outcomes without the negative aspects of multifocal IOLs such as photic phenomena or loss in contrast vision.
The aim of the study is therefore to compare two refractive enhanced monofocal IOLs in an intra-individual approach.
60 eyes of 30 patients will be included into this study. After randomization one eye is implanted with the Art 25 IOL, whereas the other eye gets the Eyhance IOL. Follow-up visits will be 1 week and 3 months after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art 25 IOL | Experimental | Device: enhanced monofocal IOLPatient will receive the Art 25 IOL during cataract surgery |
| Eyhance | Experimental | Device: enhanced monofocal IOLPatient will receive the Eyhance 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 (7 listed)
- age-related bilateral cataract
- Age 21 or older
- Visual acuity > 0.05
- Axial length: 21.00-27.00mm
- Astigmatism < 1.0 dpt
Key exclusion criteria (8 listed)
- Reduced contrast vision, binocularity or stereoscopic vision (e.g. amblyopia, strabismus)
- 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
- 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 |
|---|---|---|
| enhanced monofocal IOLArt 25 IOL, enhanced monofocal IOL | Device | Art 25 IOL |
| enhanced monofocal IOLEyhance IOL, enhanced monofocal IOL | Device | Eyhance |
Primary outcome
Distance-corrected intermediate visual acuity
Time frame: 3 months
The difference in distance-corrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs
5 secondary outcomes
Uncorrected intermediate visual acuity
Time frame: 3 months
Corrected and uncorrected distance visual acuity
Time frame: 3 months
Corrected and uncorrected near visual acuity
Time frame: 3 months
Defocus curve
Time frame: 3 months
Contrast Sensitivity
Time frame: 3 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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Oliver Findl, Prim. Univ.-Prof. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced monofocal 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Dec 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 Oliver Findl, Prim. Univ.-Prof. Dr. (+43 1 91021 ext. 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 intermediate visual acuity (time frame: 3 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 3 Dec 2025.