NCT07262021

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

CataractCataract surgeryintraocular surgery

Outcome Measures

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

    3 months

Secondary Outcomes (5)

  • Uncorrected intermediate visual acuity

    3 months

  • Corrected and uncorrected distance visual acuity

    3 months

  • Corrected and uncorrected near visual acuity

    3 months

  • Defocus curve

    3 months

  • Contrast Sensitivity

    3 months

Study Arms (2)

Art 25 IOL

EXPERIMENTAL

Patient will receive the Art 25 IOL during cataract surgery

Device: enhanced monofocal IOL

Eyhance

EXPERIMENTAL

Patient will receive the Eyhance IOL during cataract surgery

Device: enhanced monofocal IOL

Interventions

Art 25 IOL, enhanced monofocal IOL

Art 25 IOL

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

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

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Manuel Ruiss, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations