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

Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP

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.

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: Intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • VIROS, Hanusch Hospital, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LUCIA; CT LUCIA 611P - Intraocular lens	Device: Intraocular lens; Implantation as part of cataract surgery
Active Comparator: ASPHINA; CT ASPHINA 409MP - Intraocular lens	Device: Intraocular lens; Implantation as part of cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal position stability	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.	1 week to 4-6 months post-operatively

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): July 20, 2018

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CT LUCIA 611P BER-401-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No