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Investigation for Assessing the Visual Performance of Hanita Lenses Intensity SL IOL in Comparison to Alcon Panoptix IOL

NCT06084169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-09-27

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the visual performance between Intensity SL IOL and Panoptix IOL in men and women diagnosed with cataract who require cataract surgery procedure that meet the inclusion criteria and provide written informed consent will be enrolled in the study.

The main questions it aims to answer are:

1. To show non-inferiority in binocular distance corrected visual acuity for far, intermediate and near distances after Trifocal IOL implantation.
2. To show non-inferiority in the Defocus Curve measurement
3. To show non-inferiority in Contrast Sensitivity measurement
4. To show non-inferiority in patient satisfaction

Participants will attend a total of 10 study visits: 1 preoperative visit, 2 operations and 7 postoperative visits.

Conditions

  • Cataract

Interventions

DEVICE

Intra Ocular Lens (IOL) Implant

Implantable intra ocular lens instead of the cataractous lens has been removed from the patient's eye

Sponsors & Collaborators

  • Hanita Lenses

    lead INDUSTRY

Principal Investigators

  • Auffarth Gerd U., Prof. · Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2025-12-30
Completion
2026-03-01

Countries

  • Germany

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 NCT06084169 on ClinicalTrials.gov