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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595177
• Other study ID #: PresbyIOL
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: November 1, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Procedure:
• Cataract surgery with intraocular lens implantation.
Phacoemulsification under topical anesthesia with intraocular lens implantation.

Locations

Country	Name	City	State
Brazil	Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Alcon Research, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire		1 year	No