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

NCT04036149 | Completed

• 1 other identifier: CT LUCIA 611P BER-401-16
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LUCIA

EXPERIMENTAL

CT LUCIA 611P - Intraocular lens

Device: Intraocular lens

ASPHINA

ACTIVE COMPARATOR

CT ASPHINA 409MP - Intraocular lens

Device: Intraocular lens

Interventions

Intraocular lens DEVICE

Implantation as part of cataract surgery

ASPHINA; LUCIA

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

VIROS, Hanusch Hospital, Department of Ophthalmology

Vienna, Austria

Location

MeSH Terms

Interventions

Lenses, Intraocular

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 29, 2019
• Study Start: March 14, 2017
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

AU (1)