Clinical trial NCT01065064: Visual Performance After RESTOR Implantation
Official title: Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Refractive Assessment
Keywords: Multifocal IOL
ReSTOR IOL
Lead sponsor: Hospital Oftalmologico de Brasilia
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Detailed description: To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Prospective study of 50 patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation. Uncorrected distance vision acuity (UDVA), corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA), and distance-corrected intermediate visual acuity (DCIVA) were measured postoperatively. A patient-satisfaction and visual phenomena questionnaire was administered at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Cataract
* Any race
* Either gender
* Diagnosis of cataracts both eyes
* Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
* Subjects must have \< 1.00 diopter of astigmatism
* Biometry results for the Restore patients should target emmetropia or +0.25.

Exclusion Criteria:

* Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
* Retinal abnormalities
* Diabetes mellitus steroid or immunosuppressive treatment
* Connective tissue diseases

Primary outcomes:
measure: To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Oftalmologico de Brasilia
state: DF
Study officials:
affiliation: HOB; HBDF; UFMG
name: PATRICK F TZELIKIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Artem'eva LS, Asin BA, Guliaev AA. [Method of prolonged active drainage after operations on the joints in rheumatoid arthritis]. Ortop Travmatol Protez. 1979 Aug;(8):28-9. No abstract available. Russian.
citation: Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.
citation: Alfonso JF, Fernandez-Vega L, Orti S, Ferrer-Blasco T, Montes-Mico R. Refractive and visual results after implantation of the AcrySof ReSTOR IOL in high and low hyperopic eyes. Eur J Ophthalmol. 2009 Sep-Oct;19(5):748-53. doi: 10.1177/112067210901900511.