Status:
COMPLETED
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Cataract Senile
Eligibility:
All Genders
50-90 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04036149
Start Date
March 14 2017
End Date
July 20 2018
Last Update
July 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VIROS, Hanusch Hospital, Department of Ophthalmology
Vienna, Austria