Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Sponsored by Carl Zeiss Meditec AG
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
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