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

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Completed
CT.gov ID
NCT04036149
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
16.2
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intraocular lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Actual Study Start Date :
Mar 14, 2017
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VIROS, Hanusch Hospital, Department of Ophthalmology Vienna Austria

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT04036149
Other Study ID Numbers:
  • CT LUCIA 611P BER-401-16
First Posted:
Jul 29, 2019
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jul 31, 2019