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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal IOL | Experimental | 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. |
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| Monovision | Experimental | 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. |
|
| Hybrid Monovision | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery with intraocular lens implantation. | Procedure | Phacoemulsification under topical anesthesia with intraocular lens implantation. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joao Crispim, MD | Post graduated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP) | São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |