Visual Performance of Pseudophakic Patient With Different Intraocular Lenses (ETDRS)
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Purpose
This retrospective study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular Lens was been implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction and visual phenomena questionnaire was also been administered.
| Condition |
|---|
|
Cataract Lens Diseases Eye Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Visual Performance of Pseudophakic Patient With Different Intraocular Lenses |
- Visual Performance in Pseudophakic Patients With Different Intraocular Lens [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]Postoperative evaluation was been performed at 6 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) was assessed using the 100% contrast ETDRS chart; a binocular defocus curve was constructed using the ETDRS chart at 4 m.
- Contrast sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd). The background illumination of the translucent chart does not depend on room lighting. All measurements was obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations was performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements was performed under the same conditions.
- Patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]Patient satisfaction and quality of life was assessed by a simple questionnaire. Patients was interviewed 6 months postoperative. Patients was asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.
| Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Multifocal Spheric Intraocular Lens (Restor SN60D3 IOL)
No Intervention: Multifocal Spheric IOL implantation
|
|
Monofocal Spheric Intraocular Lens (AcrySof SN60AT IOL)
No Intervention: Monofocal Spheric IOL implantation
|
|
Multifocal Aspheric Intraocular Lens (Tecnis ZMA00 IOL)
No intervention Multifocal IOL implantation
|
|
Monofocal Aspheric Intraocular Lens (AcrySof SN60WF IOL)
No Intervention: Monofocal IOL implantation
|
Detailed Description:
Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam protractor after full mydriasis. The mean of the absolute values of degrees the intraocular lens was off axis was determined.
Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. The background illumination of the translucent chart does not depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were performed under the same conditions.
Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients were interviewed 3 months postoperative. Patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study population was derived from patients who had phacoemulsification with multifocal or mono focal intraocular lens (IOL) in Sao Paulo University School of Medicine, Brazil. Patients with senile cataract with vision-impairing disease characterized by gradual, progressive opacity of the lens.
Inclusion Criteria:
Cataract Any race Either gender Diagnosis of cataracts both eyes Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer Subjects must have > 1.00 diopter of astigmatism
Exclusion Criteria:
Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia Retinal abnormalities Diabetes mellitus steroid or immunosuppressive treatment Connective tissue diseases
Contacts and Locations| Brazil | |
| University of Sao Paulo | |
| Sao Paulo, Brazil, 05403010 | |
| Principal Investigator: | Wilson T Hida, MD | University of Sao Paulo, Brazil |
| Study Chair: | Newton J Kara-Junior, MD PhD | University of Sao Paulo, Brazil |
| Principal Investigator: | Celso T Nakano, MD | University of Sao Paulo, Brazil |
| Study Director: | Patrick Tzelikis, MD PhD | Hospital Oftalmologico de Brasilia |
More Information
Publications:
| Responsible Party: | Wilson Takashi Hida, MD PhD, Hospital Oftalmologico de Brasilia |
| ClinicalTrials.gov Identifier: | NCT01763411 History of Changes |
| Other Study ID Numbers: | HOB-12/12, HOB03012013 |
| Study First Received: | January 5, 2013 |
| Last Updated: | January 5, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Hospital Oftalmologico de Brasilia:
|
Cataract Vision Intraocular lens Multifocal Monofocal |
Additional relevant MeSH terms:
|
Eye Diseases Lens Diseases Cataract |
ClinicalTrials.gov processed this record on May 23, 2013