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

NCT ID: NCT04036149

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2018-07-20

Brief Summary

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.

Conditions

Cataract Senile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LUCIA

CT LUCIA 611P - Intraocular lens

Group Type: EXPERIMENTAL

Intraocular lens

Intervention Type: DEVICE

Implantation as part of cataract surgery

ASPHINA

CT ASPHINA 409MP - Intraocular lens

Group Type: ACTIVE_COMPARATOR

Intraocular lens

Intervention Type: DEVICE

Implantation as part of cataract surgery

Interventions

Intraocular lens

Implantation as part of cataract surgery

Intervention Type: DEVICE

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;
• 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.

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VIROS, Hanusch Hospital, Department of Ophthalmology

Vienna, , Austria

Countries

Austria

Other Identifiers

CT LUCIA 611P BER-401-16

Identifier Type: -

Identifier Source: org_study_id