Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Days contrast sensitivity under photopic and mesopic conditions [at 90 days postoperatively]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | : 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)
Study Documents (Full-Text)
None provided.More Information
Publications
- Dietze HH, Cox MJ. Limitations of correcting spherical aberration with aspheric intraocular lenses. J Refract Surg. 2005 Sep-Oct;21(5):S541-6.
- Kasper T, Bühren 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.
- Montés-Micó R, Ferrer-Blasco T, Cerviño 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. Review.
- 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.
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