Visual Function of Enhanced Monofocal Intraocular Lenses

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: enhanced monofocal IOL; Device: enhanced monofocal IOL

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Findl, Prim. Univ.-Prof. Dr.; Phone Number: 57564 +43 1 91021; Email: office@viros.at
• Study Contact Backup: Name: Manuel Ruiss, MSc.; Phone Number: 57564 +43 1 91021; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery
    • Contact: Oliver Findl, Prim. Univ.-Prof. Dr.; Phone Number: 57564 +43 1 91021; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Art 25 IOL; Patient will receive the Art 25 IOL during cataract surgery	Device: enhanced monofocal IOL; Art 25 IOL, enhanced monofocal IOL; Device: enhanced monofocal IOL; Eyhance IOL, enhanced monofocal IOL
Experimental: Eyhance; Patient will receive the Eyhance IOL during cataract surgery	Device: enhanced monofocal IOL; Art 25 IOL, enhanced monofocal IOL; Device: enhanced monofocal IOL; Eyhance IOL, enhanced monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	3 months
Contrast Sensitivity	The difference in contrast sensitivity between the two different IOLs	3 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prim. Univ.-Prof. Dr., Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cataract surgery; Cataract; intraocular surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Art25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No