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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04036149

Enrollment

Registered

2019-07-29

Start date

2017-03-14

Completion date

2018-07-20

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

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.

Interventions

DEVICEIntraocular lens

Implantation as part of cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026