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

Carl Zeiss Meditec

Status: Completed

Conditions: Catartact

Treatments: Device: Implantation of Acrysof IQ SN60WF IOL; Device: Implantation of CT LUCIA IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02903927

CT LUCIA 601PY BER 401-14

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

CT LUCIA

Experimental group

Treatment:

Device: Implantation of CT LUCIA IOL

Acrysof IQ Sn60WF

Active Comparator group

Treatment:

Device: Implantation of Acrysof IQ SN60WF IOL