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

NCT04036149 — Not applicable, Completed, 54 participants, Carl Zeiss Meditec AG

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

RegistryNCT04036149
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment54 (Actual)
SponsorCarl Zeiss Meditec AG (Industry)
ConditionsCataract Senile
InterventionsIntraocular lens (Device)
Datesstart 2017-03-14, primary completion 2018-07-20, completion 2018-07-20, first posted 2019-07-29, last updated 2019-07-31
Locations1 site in Austria

Related Papers Related Patents Related Grants Related Experts
All trials for Cataract Senile All trials of Intraocular lens

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
LUCIAExperimentalDevice: Intraocular lensCT LUCIA 611P - Intraocular lens
ASPHINAActive comparatorDevice: Intraocular lensCT ASPHINA 409MP - Intraocular lens
  • Intraocular lens (Device): Implantation as part of cataract surgery

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 50 Years to 90 Years

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

+Locations (1)

FacilityCityCountryStatus
VIROS, Hanusch Hospital, Department of OphthalmologyViennaAustria