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Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL

NCT06105190 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2025-02-12

No results posted yet for this study

Summary

This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).

Conditions

  • Cataract
  • Lens Opacities

Interventions

DEVICE

Implantation of premium monofocal IOL, LuxSmart (device under investigation)

Patients will be implanted with study IOL in both eyes

DEVICE

Implantation of monofocal IOL, LuxGood (control device)

Patients will be implanted with Control IOL in both eyes

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Cutting Edge SAS

    lead INDUSTRY

Principal Investigators

  • Burkhard Dick, Prof. · Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Austria
  • Czechia
  • Germany
  • Philippines
  • Singapore
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105190 on ClinicalTrials.gov