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

Federal University of São Paulo

Status: Completed

Conditions: Cataract; Presbyopia

Treatments: Procedure: Cataract surgery with intraocular lens implantation.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02595177

PresbyIOL

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Multifocal IOL

Experimental group

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.

Treatment:

Procedure: Cataract surgery with intraocular lens implantation.

Monovision

Experimental group

Description:

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.

Treatment:

Procedure: Cataract surgery with intraocular lens implantation.

Hybrid Monovision

Experimental group

Description:

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.

Treatment:

Procedure: Cataract surgery with intraocular lens implantation.