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Not yet recruiting NCT07262021

Visual Function of Enhanced Monofocal Intraocular Lenses

No phase Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: enhanced monofocal IOL, enhanced monofocal IOL.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: 21 years — 105 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device enhanced monofocal IOL
    Art 25 IOL, enhanced monofocal IOL
  • Device enhanced monofocal IOL
    Eyhance IOL, enhanced monofocal IOL

Primary outcome measures

  • Distance-corrected intermediate visual acuity [Time frame: 3 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Vienna Institute for Research in Ocular Surgery — Vienna

Identifiers

NCT: NCT07262021 · Art25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗