Clinical trial NCT00863759: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lens Implantation, Intraocular
Keywords: intra-ocular lenses
comparative study
Ocular aberrations
Contrast Sensitivity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ocular aberrations with a 5.0 mm and 6.0 mm pupil measured with a dynamic retinoscopy aberrometer
timeFrame: At 30 and 90 days postoperatively
Secondary outcomes:
measure: Days contrast sensitivity under photopic and mesopic conditions
timeFrame: at 90 days postoperatively
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: : Department of ophthalmology, Hospital das Clinicas, University of São Paulo
Study officials:
affiliation: University of Sao Paulo (ophthalmology department of Hospital das Clinicas)
name: Marcony R Santhiago, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.