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OpenTrials
Completed

NCT Number: NCT04036149

To Compare 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.

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Key information

Conditions

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIROS, Hanusch Hospital, Department of Ophthalmology

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular lens

Device

Implantation as part of cataract surgery

Primary outcomes

  1. Horizontal position stability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2019
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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