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

Not Applicable

Completed

• Conditions: Cataract Senile
• Interventions: Device: Intraocular lens

• Registration Number: NCT04036149
• Lead Sponsor: Carl Zeiss Meditec AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-14
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2019-07
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUCIA	Intraocular lens	CT LUCIA 611P - Intraocular lens
ASPHINA	Intraocular lens	CT ASPHINA 409MP - Intraocular lens

Primary Outcome Measures

Name	Time	Method
Horizontal position stability	1 week to 4-6 months post-operatively	Evaluation of the horizontal position stability of the CT LUCIA 611P IOL. The horizontal position at M1 and M4-6 will be compared to the horizontal IOL position at baseline (W1) and to the position stability of the reference IOL, CT ASPHINA 409MP.

Trial Locations

Locations (1)

VIROS, Hanusch Hospital, Department of Ophthalmology; 🇦🇹 Vienna, Austria