Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT02903927
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT02903927
Study Brief:
Protocol Section:
NCT02903927