This trial is active, not recruiting.

Condition catartact
Treatments implantation of ct lucia iol, implantation of acrysof iq sn60wf iol
Sponsor Carl Zeiss Meditec AG
Start date May 2014
End date January 2015
Trial identifier NCT02903927, CT LUCIA 601PY BER 401-14


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
implantation of ct lucia iol
(Active Comparator)
implantation of acrysof iq sn60wf iol

Primary Outcomes

Uncorrected distance visual acuity (UCVA) (monocular)
time frame: 6 months

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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 information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Carl Zeiss Meditec AG.