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

NCT ID: NCT02595177

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Cataract; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cataract surgery with intraocular lens implantation.

Intervention Type: PROCEDURE

Phacoemulsification under topical anesthesia with intraocular lens implantation.

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.

Group Type: EXPERIMENTAL

Cataract surgery with intraocular lens implantation.

Intervention Type: PROCEDURE

Phacoemulsification under topical anesthesia with intraocular lens implantation.

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.

Group Type: EXPERIMENTAL

Cataract surgery with intraocular lens implantation.

Intervention Type: PROCEDURE

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Interventions

Cataract surgery with intraocular lens implantation.

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Intervention Type: PROCEDURE

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);

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Joao Crispim

Post graduated

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joao Crispim, MD

Role: PRINCIPAL_INVESTIGATOR

Post graduated

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PresbyIOL

Identifier Type: -

Identifier Source: org_study_id