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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02595177

Collaborator

Alcon Research (Industry), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Presbyopia	Procedure: Cataract surgery with intraocular lens implantation.	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multifocal IOL 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. Phacoemulsification under topical anesthesia with intraocular lens implantation.
Experimental: Monovision 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. Phacoemulsification under topical anesthesia with intraocular lens implantation.
Experimental: Hybrid Monovision 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. Phacoemulsification under topical anesthesia with intraocular lens implantation.

Arm

Intervention/Treatment

Experimental: Multifocal IOL

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.

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Experimental: Monovision

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.

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Experimental: Hybrid Monovision

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.

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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);