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CompletedNCT02903927LUCIOLUpdated Jan 29, 2018

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

An interventional study of Implantation of CT LUCIA IOL and Implantation of Acrysof IQ SN60WF IOL in Catartact, sponsored by Carl Zeiss Meditec AG. Completed. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by Carl Zeiss Meditec AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled May 2014, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Catartact
03

In context

Lead sponsor

Carl Zeiss Meditec AG is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
81 participants (actual)

Study arms

  • Experimental
    CT LUCIA

    Device: Implantation of CT LUCIA IOL

  • Active comparator
    Acrysof IQ Sn60WF

    Device: Implantation of Acrysof IQ SN60WF IOL

Interventions

  • DeviceImplantation of CT LUCIA IOL
  • DeviceImplantation of Acrysof IQ SN60WF IOL
06

What researchers measure

Primary outcomes

  1. Uncorrected distance visual acuity (UCVA) (monocular)

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02903927
Lead sponsor
Carl Zeiss Meditec AG
Responsible party
Sponsor
First posted
Sep 16, 2016
Start date
May 20, 2014
Primary completion
Jun 6, 2016
Completion
Oct 10, 2016
Last update
Jan 29, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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