Visual Performance After RESTOR Implantation

Refractive Assessment Clinical Trial

Official title:

Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065064
• Other study ID #: HOB-01/09
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: February 8, 2010
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: Hospital Oftalmologico de Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Assessment

Intervention

Procedure:
• RESTOR IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery

Locations

Country	Name	City	State
Brazil	Hospital Oftalmologico de Brasilia	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Oftalmologico de Brasilia

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Alfonso JF, Fernández-Vega L, Ortí S, Ferrer-Blasco T, Montés-Micó 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. — View 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. Russian. — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.		6 months	Yes