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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00863759
First received: March 17, 2009
Last updated: July 1, 2010
Last verified: March 2009
  Purpose

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.


Condition Intervention
Lens Implantation, Intraocular
Procedure: implantation of intraocular lens (IOL)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days contrast sensitivity under photopic and mesopic conditions [ Time Frame: at 90 days postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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)

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)
Active Comparator: 2
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)

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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863759

Locations
Brazil
: Department of ophthalmology, Hospital das Clinicas, University of São Paulo
São Paulo, Brazil, 05403.001
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Marcony R Santhiago, MD University of Sao Paulo (ophthalmology department of Hospital das Clinicas)
  More Information