ClinicalTrials.gg
Not yet recruitingNCT07262021Updated Dec 3, 2025

Visual Function of Enhanced Monofocal Intraocular Lenses

An interventional study of enhanced monofocal IOL and enhanced monofocal IOL in Cataract, sponsored by Vienna Institute for Research in Ocular Surgery. Not yet recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 105 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract
  • Cataract surgery
  • intraocular surgery
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 30 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 prior to surgery

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Art 25 IOL

    Patient will receive the Art 25 IOL during cataract surgery

    Device: enhanced monofocal IOL

  • Experimental
    Eyhance

    Patient will receive the Eyhance IOL during cataract surgery

    Device: enhanced monofocal IOL

Interventions

  • Deviceenhanced monofocal IOL

    Art 25 IOL, enhanced monofocal IOL

  • Deviceenhanced monofocal IOL

    Eyhance IOL, enhanced monofocal IOL

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: 3 months

  4. Defocus curve

    The difference in visual acuity assessed in the defocus curve before and after surgery and compared between the two different IOLs

    Time frame: 3 months

  5. Contrast Sensitivity

    The difference in contrast sensitivity between the two different IOLs

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2025; primary completion for Nov 2026, 11 months later.

Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2025
First posted
Dec 3, 2025
StartEst.
Dec 1, 2025
Primary completionEst.
Nov 1, 2026
CompletionEst.
Nov 1, 2027
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07262021
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Dec 3, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Dec 3, 2025

Study contacts

Oliver Findl, Prim. Univ.-Prof. Dr.
Contact
office@viros.at
+43 1 91021 ext. 57564
Manuel Ruiss, MSc.
Contact
office@viros.at
+43 1 91021 ext. 57564
Oliver Findl, Prim. Univ.-Prof. Dr.
principal investigator · Vienna Institute for Research in Ocular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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