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Trial record 2 of 432 for:    cataract AND intraocular lens

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

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ClinicalTrials.gov Identifier: NCT02595177
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Collaborators:
Alcon Research
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Joao Crispim, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Cataract Presbyopia Procedure: Cataract surgery with intraocular lens implantation. Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595177


Locations
Brazil
Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Alcon Research
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Joao Crispim, MD Post graduated

Responsible Party: Joao Crispim, Post graduated, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02595177     History of Changes
Other Study ID Numbers: PresbyIOL
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Joao Crispim, Federal University of São Paulo:
multifocal IOL
monovision
hybrid monovision
spectacles independence

Additional relevant MeSH terms:
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors