Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract Surgery

Study Overview
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Brief Summary
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To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.

Detailed Description
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The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.

Official Title
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Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Procedure: Cataract surgery with intraocular lens implantation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral senile cataracts. Implantation of IOL in the capsular bag; Implants from 10-30 diopter; Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery; Exclusion Criteria: Amblyopia; Single Eye; History of intraocular surgery in the previous year; Sequel to prior ocular trauma; Important Microphthalmia or aniridia; History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata); Corneal astigmatism > 1.0 D; IOP ≥ 21 mmHg in standard caliper; Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy); Pupil > 5 mm or < 2 mm under photopic conditions; Asymmetrical pupils in the eye or between the eyes; Binocular vision absence; Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example); Patient probably need to laser treatment of the retina; Patients whose expectations are unrealistic; Patients whose lifestyle involves high expectations of visual acuity (writer, driver, for example); Patients at risk of not meeting the clinical follow-up requirements (distance of travel difficulties, for example);

Ages Eligible for Study
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Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal IOL<br>Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, multifocal intraocular lens implantation in both eyes planning for emmetropia complete the intervention. | Procedure: Cataract surgery with intraocular lens implantation.<br>* Phacoemulsification under topical anesthesia with intraocular lens implantation.<br>|
| Experimental: Monovision<br>Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation planning for emmetropia in one eye (dominant) and a monofocal IOL planning for 1.50 D of myopia in the other eye (non-dominant) complete the intervention. | Procedure: Cataract surgery with intraocular lens implantation.<br>* Phacoemulsification under topical anesthesia with intraocular lens implantation.<br>|
| Experimental: Hybrid Monovision<br>Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation in the dominant eye and a multifocal IOL in the non-dominant eye complete the intervention. | Procedure: Cataract surgery with intraocular lens implantation.<br>* Phacoemulsification under topical anesthesia with intraocular lens implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed reading measure | Assessment is performed to measure the speed reading in each group and compare them. Then using a timer to measure how long does it take to read the page. The speed reading is measured in words per minute (WPM). | 1 year | 
| Near stereopsis measure | Calculate stereopsis in each group and compare them. Stereoacuity is measured using a stereogram in which separate panels are shown to each eye. | 1 year | 
| Contrast sensitivity measure | Comparison between groups of the contrast sensitivity. Contrast sensitivity function at five spatial frequencies is measured with the validated instrument (Functional Vision Analyzer® (Stereo Optical, Chicago, IL, USA) with best refraction. | 1 year | 
| National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multifocal IOL, monovision, hybrid monovision, spectacles independence