A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00

Study Overview
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Brief Summary
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This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.

Official Title
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A Randomised, Controlled Study to Compare Visual Performance, Refractive Outcome, Forward Light Scatter, Patient Satisfaction and Objective Measurement of Glistenings Following Insertion of Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 Lenses

Conditions
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Cataract Extraction, Phacoemulsification, Glistenings, Intraocular Lens Implant, Hydrophobic Acrylic, Cataract Surgery, Light Scatter, Patient Satisfaction, Patient Related Outcome Measures

Intervention / Treatment
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* Device: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral cataracts good visual potential ability to understand informed consent and objectives of the trial not-pregnant not breast feeding no previous eye surgery corneal astigmatism less than 1 diopter in both eyes Exclusion Criteria: age-related macula degeneration glaucoma previous retinal vascular disorders previous retinal detachment or tear any neuro-ophthalmological condition any inherited retinal disorder or pathology previous strabismus surgery or record of amblyopia previous transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease already enrolled in another study Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, such as: Significant corneal opacities Small pupils following pharmacological dilatation Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Experimental intraocular lens implant<br>'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant | Device: Cataract surgery<br>* Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant<br>|
| Active Comparator: Standard intraocular lens implant<br>Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant | Device: Cataract surgery<br>* Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | As measured by conventional LogMAR visual acuity charts | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraocular lens glistenings | Incidence of presence of intraocular lens glistenings in each study arm | 13 months | 
| Severity of intraocular lens glistenings | Number of vacuoles per square millimetre | 13 months | 
| Refraction (i.e. glasses prescription) | In conventional sphere/cylinder dioptre scales: total range -40 to +40, in 0.25 steps. Higher values represent worse outcome. Values closer to 0 (zero) represent better outcome | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures