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NCT Number: NCT07262021

Visual Function of Enhanced Monofocal Intraocular Lenses

Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery

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Key information

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location contact

Oliver Findl, Prim. Univ.-Prof. Dr.

CONTACT

[email protected]

+43 1 91021 ext. 57564

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent prior to surgery

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

Treatment and study plan

enhanced monofocal IOL

Device

Art 25 IOL, enhanced monofocal IOL

Primary outcomes

  1. 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

Secondary outcomes

  1. Uncorrected intermediate visual acuity

    Time frame: 3 months

    The difference in uncorrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs

  2. Corrected and uncorrected distance visual acuity

    Time frame: 3 months

    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

  3. Corrected and uncorrected near visual acuity

    Time frame: 3 months

    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

  4. Defocus curve

    Time frame: 3 months

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

  5. Contrast Sensitivity

    Time frame: 3 months

    The difference in contrast sensitivity between the two different IOLs

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Ruiss, MSc.

CONTACT

[email protected]

+43 1 91021 ext. 57564

Oliver Findl, Prim. Univ.-Prof. Dr.

CONTACT

[email protected]

+43 1 91021 ext. 57564

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Comparison of Visual Function of Enhanced Monofocal Intraocular Lenses After Cataract Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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