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Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

NCT04465344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-02-12

No results posted yet for this study

Summary

The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.

Conditions

  • Cataract
  • Lens Opacities

Interventions

DEVICE

Implantation of trifocal IOL, Isatis TF (device under investigation)

Patients will be implanted with study IOL in both eyes

DEVICE

Implantation of monofocal IOL, Isatis (control device)

Patients will be implanted with Control IOL in both eyes

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Cutting Edge SAS

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2024-06-27
Completion
2024-06-27

Countries

  • Czechia
  • 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 NCT04465344 on ClinicalTrials.gov