Visual Performance of Pseudophakic Patient With Different Intraocular Lenses (ETDRS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Wilson Takashi Hida, Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier:
NCT01763411
First received: January 5, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Hospital Oftalmologico de Brasilia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763411

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05403010
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
University of Sao Paulo
Investigators
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:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on September 16, 2014