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OpenTrials
Completed

NCT Number: NCT00863759

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

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.

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Key information

Conditions

Lens Implantation, Intraocular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

: Department of ophthalmology, Hospital das Clinicas, University of São Paulo

São Paulo, 05403.001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

implantation of intraocular lens (IOL)

Procedure

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.

Other names: Implantation of aspheric Akreos AO intraocular lenses (IOL), Implantation of spheric Akreos Fit intraocular lenses (IOL)

Primary outcomes

  1. Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer

    Time frame: At 30 and 90 days postoperatively

Secondary outcomes

  1. Days contrast sensitivity under photopic and mesopic conditions

    Time frame: at 90 days postoperatively

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2009
Registry last updated
Jul 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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