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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Lens Implantation, Intraocular

Intervention / Treatment
-----------------
* Procedure: implantation of intraocular lens (IOL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters) Exclusion Criteria: Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities Surgical complications Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination) Incomplete follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will receive an aspheric intraocular lenses (IOL) Akreos AO in the right eye and an spheric IOL Akreos Fit in the left eye, during cataract surgery. | Procedure: implantation of intraocular lens (IOL)<br>* 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.<br>* Other names: Implantation of spheric Akreos Fit intraocular lenses (IOL);|
| Active Comparator: 2<br>Patients will receive an spheric intraocular lens (IOL) Akreos Fit in the right eye and an aspheric IOL Akreos AO in the left eye, during cataract surgery. | Procedure: implantation of intraocular lens (IOL)<br>* 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.<br>* Other names: Implantation of spheric Akreos Fit intraocular lenses (IOL);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer |  | At 30 and 90 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days contrast sensitivity under photopic and mesopic conditions |  | at 90 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-ocular lenses, comparative study, Ocular aberrations, Contrast Sensitivity