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

Primary Purpose

Cataract, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Cataract surgery with intraocular lens implantation.

About this trial

This is an interventional treatment trial for Cataract focused on measuring multifocal IOL, monovision, hybrid monovision, spectacles independence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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);

Sites / Locations

Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Multifocal IOL

Monovision

Hybrid Monovision

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire

Full Information

NCT ID

NCT02595177

First Posted

October 27, 2015

Last Updated

November 1, 2015

Sponsor

Federal University of São Paulo

Collaborators

Alcon Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

1. Study Identification

Unique Protocol Identification Number

NCT02595177

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

Collaborators

Alcon Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Presbyopia

Keywords

multifocal IOL, monovision, hybrid monovision, spectacles independence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multifocal IOL

Arm Type

Experimental

Arm Description

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.

Arm Title

Monovision

Arm Type

Experimental

Arm Description

Arm Title

Hybrid Monovision

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Cataract surgery with intraocular lens implantation.

Intervention Description

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Primary Outcome Measure Information:

Title

Visual acuity

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Speed reading measure

Description

Time Frame

1 year

Title

Near stereopsis measure

Description

Calculate stereopsis in each group and compare them. Stereoacuity is measured using a stereogram in which separate panels are shown to each eye.

Time Frame

1 year

Title

Contrast sensitivity measure

Description

Time Frame

1 year

Title

National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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);

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joao Crispim, MD

Organizational Affiliation

Post graduated

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)

City

Sao Paulo

State/Province

Country

Brazil

12. IPD Sharing Statement

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

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