Clinical Trials Directory

Trials / Completed

CompletedNCT00863759

Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation

Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery. Study hypothesis: the implantation of an intraocular lens (IOL) with a modified anterior and posterior aspherical surface (Akreos AO, Bausch \& Lomb,Inc) results in reduced ocular aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery. Setting: Department of ophthalmology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. Overall Study design: This will be an intraindividual randomized double-blinded prospective study. Patients will be randomized to receive an aspheric IOL Akreos AO in one eye (25 eyes; Bausch \& Lomb, Inc), and an spheric IOL Akreos Fit (25 eyes; Bausch \& Lomb, Inc.) in the fellow eye. Ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic retinoscopy aberrometer after 1 and 3 months. Uncorrected and best-corrected visual acuity, out-focus performance and contrast sensitivity under mesopic and photopic conditions will be also measured. All patients will be followed for 3 months.

Detailed description

Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up. Patients will be examined before surgery and at 1, 7, 30, 90 days after surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREimplantation of intraocular lens (IOL)implantation of intraocular lens during cataract surgery. Arm 1: implantation of aspheric IOL Akreos AO in right eye and an spheric IOL Akreos Fit in left eye. Arm 2: implantation of aspheric IOL Akreos AO in left eye and an spheric IOL Akreos Fit in right eye.

Timeline

Start date
2009-03-01
Primary completion
2009-11-01
Completion
2009-11-01
First posted
2009-03-18
Last updated
2010-07-02

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00863759. Inclusion in this directory is not an endorsement.