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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036149
• Other study ID #: CT LUCIA 611P BER-401-16
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2019
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Device:
• Intraocular lens
Implantation as part of cataract surgery

Locations

Country	Name	City	State
Austria	VIROS, Hanusch Hospital, Department of Ophthalmology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal position stability	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.	1 week to 4-6 months post-operatively