Clinical trial NCT04036149: To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Official title: Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Horizontal position stability
timeFrame: 1 week to 4-6 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS, Hanusch Hospital, Department of Ophthalmology
Study officials:
References: