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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract Senile

Intervention / Treatment
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* Device: Intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUCIA<br>CT LUCIA 611P - Intraocular lens | Device: Intraocular lens<br>* Implantation as part of cataract surgery<br>|
| Active Comparator: ASPHINA<br>CT ASPHINA 409MP - Intraocular lens | Device: Intraocular lens<br>* Implantation as part of cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |