Wavefront Analysis and Contrast Sensitivity After Cataract Surgery With Akreos Advanced Optics Intraocular Lens Implantation
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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 |
- 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 ]
- 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:
|
|
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:
|
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 |
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| Brazil | |
| : Department of ophthalmology, Hospital das Clinicas, University of São Paulo | |
| São Paulo, Brazil, 05403.001 | |
| Principal Investigator: | Marcony R Santhiago, MD | University of Sao Paulo (ophthalmology department of Hospital das Clinicas) |
More Information
Publications:
| Responsible Party: | Marcony Santhiago, MD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00863759 History of Changes |
| Other Study ID Numbers: | 656/06 |
| Study First Received: | March 17, 2009 |
| Last Updated: | July 1, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
intra-ocular lenses comparative study Ocular aberrations Contrast Sensitivity |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013