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

Primary Purpose

Lens Implantation, Intraocular

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
implantation of intraocular lens (IOL)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lens Implantation, Intraocular focused on measuring intra-ocular lenses, comparative study, Ocular aberrations, Contrast Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Days contrast sensitivity under photopic and mesopic conditions

Full Information

First Posted
March 17, 2009
Last Updated
July 1, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00863759
Brief Title
Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation
Official Title
Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos AO Intraocular Lens Implantation: Clinical Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lens Implantation, Intraocular
Keywords
intra-ocular lenses, comparative study, Ocular aberrations, Contrast Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
implantation of intraocular lens (IOL)
Other Intervention Name(s)
Implantation of aspheric Akreos AO intraocular lenses (IOL), Implantation of spheric Akreos Fit intraocular lenses (IOL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Days contrast sensitivity under photopic and mesopic conditions
Time Frame
at 90 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcony R Santhiago, MD
Organizational Affiliation
University of Sao Paulo (ophthalmology department of Hospital das Clinicas)
Official's Role
Principal Investigator
Facility Information:
Facility Name
: Department of ophthalmology, Hospital das Clinicas, University of São Paulo
City
São Paulo
ZIP/Postal Code
05403.001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19101441
Citation
Montes-Mico R, Ferrer-Blasco T, Cervino A. Analysis of the possible benefits of aspheric intraocular lenses: review of the literature. J Cataract Refract Surg. 2009 Jan;35(1):172-81. doi: 10.1016/j.jcrs.2008.09.017.
Results Reference
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PubMed Identifier
18291345
Citation
Tzelikis PF, Akaishi L, Trindade FC, Boteon JE. Spherical aberration and contrast sensitivity in eyes implanted with aspheric and spherical intraocular lenses: a comparative study. Am J Ophthalmol. 2008 May;145(5):827-33. doi: 10.1016/j.ajo.2007.12.023. Epub 2008 Mar 4.
Results Reference
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PubMed Identifier
16516783
Citation
Kasper T, Buhren J, Kohnen T. Intraindividual comparison of higher-order aberrations after implantation of aspherical and spherical intraocular lenses as a function of pupil diameter. J Cataract Refract Surg. 2006 Jan;32(1):78-84. doi: 10.1016/j.jcrs.2005.11.018.
Results Reference
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PubMed Identifier
16209458
Citation
Dietze HH, Cox MJ. Limitations of correcting spherical aberration with aspheric intraocular lenses. J Refract Surg. 2005 Sep-Oct;21(5):S541-6. doi: 10.3928/1081-597X-20050901-24.
Results Reference
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Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation

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