Clinical trial NCT02595177: Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract Surgery
Official title: Multifocal Intraocular Lens vs. Monovision vs. Hybrid Monovision After Bilateral Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Keywords: multifocal IOL
monovision
hybrid monovision
spectacles independence
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Alcon Research
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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);

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Speed reading measure
timeFrame: 1 year
measure: Near stereopsis measure
timeFrame: 1 year
measure: Contrast sensitivity measure
timeFrame: 1 year
measure: National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)
state: SP
Study officials:
affiliation: Post graduated
name: Joao Crispim, MD
role: PRINCIPAL_INVESTIGATOR
References: