Visual Outcomes After Implantation of a New Multifocal Intraocular Lens

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier:
NCT01505816
First received: January 3, 2012
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity will be evaluated. A patient-satisfaction and visual phenomena questionnaire will also be administered.


Condition Intervention Phase
Cataract
Device: Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Outcomes After Implantation of a New Refractive Toric Multifocal Intraocular Lens

Resource links provided by NLM:


Further study details as provided by Hospital Oftalmologico de Brasilia:

Primary Outcome Measures:
  • Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]
    Postoperative evaluation will be performed at 3 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) will be assessed using the 100% contrast ETDRS chart; a binocular defocus curve will be constructed using the ETDRS chart at 4 m.


Secondary Outcome Measures:
  • Contrast sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Contrast sensitivity will be 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 will be obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations will be performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements will be performed under the same conditions.

  • Patient satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient satisfaction and quality of life will be assessed by a simple questionnaire. Patients will be interviewed 3 months postoperative. Patients will be asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.


Enrollment: 40
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Toric
Multifocal Toric IOL implantation
Device: Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Multifocal IOL implantation
Other Name: RAYNER M-FLEX T TORIC IOL

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
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: NCT01505816

Locations
Brazil
Hospital Oftalmologico Brasilia
Brasilia, DF, Brazil, 70200670
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
University of Sao Paulo
Investigators
Principal Investigator: PATRICK F TZELIKIS, MD, PhD HOSPITAL OFTALMOLOGICO BRASILIA
  More Information

Publications:
Responsible Party: PATRICK FRENSEL DE MORAES TZELIKIS, Principal Investigator, Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier: NCT01505816     History of Changes
Other Study ID Numbers: HOB05, HOBBrasilia05
Study First Received: January 3, 2012
Last Updated: January 6, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Oftalmologico de Brasilia:
Cataract
Vision
Intraocular lens
Multifocal
Toric

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 23, 2014