Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses (LUCIOL)

January 25, 2018 updated by: Carl Zeiss Meditec AG

Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses

The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
  • Patients of any gender, aged 50 to 90 years;
  • Senile cataract in at least 1 eye;
  • Assured follow-up examinations;
  • Healthy eyes besides clinically significant cataract
  • Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Post-operative inclusion criteria:

  • IOL implanted in the capsular bag;
  • The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
  • No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.

Exclusion Criteria:

  • • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;

    • Patients whose freedom is impaired by administrative or legal order;
    • Current participation in another drug or device investigation;
    • Allergy to heparin
    • Monophthalmic patient
    • Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye
    • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
    • Diabetic retinopathy
    • Traumatic cataract
    • Aniridia
    • Microphthalmus
    • Amblyopia
    • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
    • Patient expected to require retinal laser treatment before the end of the follow-up
    • Previous intraocular and corneal surgery
    • Expected postop. astigmatism greater than 1 D
    • Any type of corneal disorder
    • Dementia
    • Diabetes mellitus
    • Pseudoexfoliation syndrome (PXF)
    • Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
    • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT LUCIA
Device: Implantation of CT LUCIA IOL
Active Comparator: Acrysof IQ Sn60WF
Device: Implantation of Acrysof IQ SN60WF IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uncorrected distance visual acuity (UCVA) (monocular)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2014

Primary Completion (Actual)

June 6, 2016

Study Completion (Actual)

October 10, 2016

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CT LUCIA 601PY BER 401-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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