To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP

Carl Zeiss Meditec

Status

Completed

Conditions

Cataract Senile

Treatments

Device: Intraocular lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT04036149

CT LUCIA 611P BER-401-16

Details and patient eligibility

About

The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.

Enrollment

54 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;
Assured follow-up examinations;
Healthy eyes besides clinically significant bilateral age-related cataract.
Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
Calculated IOL power within the available dioptre range;
Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Per operative inclusion criteria:

IOL implanted in the capsular bag;
The 2 IOL models (CT LUCIA 611P and CT ASPHINA 409MP) have been implanted in the 2 eyes of one patient;
No intraoperative complications; no damaged capsular bag, no intraocular haemorrhage; no can opener rhexis.

Exclusion criteria

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 in either eye;
Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
Floppy iris syndrome;
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 last follow-up;
Previous intraocular and corneal surgery;
Expected postop. astigmatism greater than 1 D;
Any type of corneal disorder;
Dementia;
Pseudoexfoliation syndrome (PEX);
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.
Pregnancy and/or lactation