Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

Study Overview
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Brief Summary
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To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.

Detailed Description
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The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively. The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses. Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.

Official Title
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Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study

Conditions
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Cataract

Intervention / Treatment
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* Device: ICB00 IOL
* Device: ZCB00 IOL
* Device: CNA0T0 IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically significant bilateral cataract (BCVA <20/40, cataract must be the primary cause of visual impairment) axial length between 21 and 27 mm the patient must be able to read, understand and provide written informed consent, the patient must be willing and able to comply with all study and follow-up procedures preoperative refractive cylinder ≤ 0.75 D Exclusion Criteria: anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus) diabetic retinopathy uncontrolled glaucoma and/or intraocular pressure IOP> 24 mmHg all types of infections (acute eye disease, external/internal infection, systemic infection) traumatic cataract pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm microphthalmia amblyopia degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders) previous intraocular and corneal surgery systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus) period of pregnancy or breastfeeding for female patients

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICB00 Group<br>ICB00 IOL | Device: ICB00 IOL<br>* Bilateral implantation of ICB00 IOL<br>* Other names: TECNIS EYHANCE IOL;|
| Active Comparator: ZCB00 Group<br>ZCB00 IOL | Device: ZCB00 IOL<br>* Bilateral implantation of ZCB00 IOL<br>|
| Active Comparator: CNA0T0 Group<br>CNA0T0 IOL | Device: CNA0T0 IOL<br>* Bilateral implantation of CNA0T0 IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bino DCIVA | Binocular distance corrected intermediate visual acuity | 12 weeks after second eye surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mono DCIVA | Monocular distance corrected intermediate visual acuity | 12 weeks after second eye surgery | 
| Mono UIVA | Monocular uncorrected intermediate visual acuity | 12 weeks after second eye surgery | 
| Bino UIVA | Binocular uncorrected intermediate visual acuity | 12 weeks after second eye surgery | 
| Mono UDVA | Monocular uncorrected distance visual acuity | 12 weeks after second eye surgery | 
| Bino UDVA | Binocular uncorrected distance visual acuity | 12 weeks after second eye surgery | 
| Mono BCDVA | Monocular best corrected distance visual acuity | 12 weeks after second eye surgery | 
| Bino BCDVA | Binocular best corrected distance visual acuity | 12 weeks after second eye surgery | 
| Mono UNVA | Monocular uncorrected near visual acuity | 12 weeks after second eye surgery | 
| Bino UNVA | Binocular uncorrected near visual acuity | 12 weeks after second eye surgery | 
| Mono CNVA | Monocular corrected near visual acuity | 12 weeks after second eye surgery | 
| Bino CNVA | Binocular corrected near visual acuity | 12 weeks after second eye surgery | 
| Binocular defocus curves | Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D) | 12 weeks after second eye surgery | 
| Catquest 9SF score changes | Changes in Catquest 9SF score before and 3 months after surgery | preop and 12 weeks after second eye surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, intermediate distance, cataract surgery, enhanced monofocal