Cataract, Presbyopia
Conditions
Keywords
multifocal IOL, monovision, hybrid monovision, spectacles independence
Brief summary
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
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.
Interventions
PROCEDURECataract surgery with intraocular lens implantation.
Phacoemulsification under topical anesthesia with intraocular lens implantation.
Sponsors
Alcon Research
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speed reading measure | 1 year | 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). |
| Near stereopsis measure | 1 year | Calculate stereopsis in each group and compare them. Stereoacuity is measured using a stereogram in which separate panels are shown to each eye. |
| Contrast sensitivity measure | 1 year | 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. |
| National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire | 1 year | — |
Countries
Brazil
Outcome results
None listed