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

Not Applicable

Completed

• Conditions: Catartact
• Interventions: Device: Implantation of CT LUCIA IOL; Device: Implantation of Acrysof IQ SN60WF IOL

• Registration Number: NCT02903927
• Lead Sponsor: Carl Zeiss Meditec AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-20
• Primary Completion: 2016-06-06
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Study Completion: 2016-10-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT LUCIA	Implantation of CT LUCIA IOL	-
Acrysof IQ Sn60WF	Implantation of Acrysof IQ SN60WF IOL	-

Primary Outcome Measures

Name	Time	Method
Uncorrected distance visual acuity (UCVA) (monocular)	6 months