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

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

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

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Procedure: Cataract surgery with intraocular lens implantation.

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil
      • Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Alcon Research
• Investigators: Principal Investigator: Joao Crispim, MD, Post graduated

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: November 1, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: multifocal IOL; monovision; hybrid monovision; spectacles independence
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PresbyIOL