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

NCT00863759 | Completed

• 1 other identifier: 656/06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lens Implantation, Intraocular

Keywords

intra-ocular lenses; comparative study; Ocular aberrations; Contrast Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Days contrast sensitivity under photopic and mesopic conditions

  at 90 days postoperatively

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Implantation of aspheric Akreos AO intraocular lenses (IOL), Implantation of spheric Akreos Fit intraocular lenses (IOL)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0D (diopters)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403.001, Brazil

Location

Related Publications (4)

• 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.

  PMID: 19101441 BACKGROUND

• 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.

  PMID: 18291345 BACKGROUND

• 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.

  PMID: 16516783 BACKGROUND

• 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.

  PMID: 16209458 BACKGROUND

MeSH Terms

Interventions

Lens Implantation, Intraocular

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marcony R Santhiago, MD

  University of Sao Paulo (ophthalmology department of Hospital das Clinicas)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 2, 2010

Record last verified: 2009-03

Locations

BR (1)