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OpenTrials
Completed

NCT Number: NCT02595177

Multifocal Intraocular Lens x Monovision x 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Cataract surgery with intraocular lens implantation.

Procedure

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Primary outcomes

  1. Visual acuity

    Time frame: 1 year

    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 outcomes

  1. Speed reading measure

    Time frame: 1 year

    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).

  2. Near stereopsis measure

    Time frame: 1 year

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

  3. Contrast sensitivity measure

    Time frame: 1 year

    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.

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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