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Spherical Aberration and Contrast Sensitivity in IOLs (IOLs)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576485
First Posted: December 19, 2007
Last Update Posted: October 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of Minas Gerais
  Purpose

Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery.

Design: Prospective, comparative, interventional case series.

Methods: In an intraindividual randomized prospective study of 25 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of vision was measured by visual acuity and contrast sensitivity under mesopic and photopic conditions. All patients were followed for 3 months.


Condition Intervention Phase
Cataract Signs and Symptoms Pseudophakia Lens Diseases Procedure: Cataract surgery and intraocular lens implantation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Spherical Aberration and Contrast Sensitivity in Eyes Implanted With Aspheric and Spherical Intraocular Lenses: Clinical Comparative Study

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery [ Time Frame: within the first 30 days of surgery ]

Enrollment: 25
Study Start Date: February 2005
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
Cataract surgery and implantation of a spherical intraocular lens
Procedure: Cataract surgery and intraocular lens implantation
Cataract surgery and implantation of an intraocular lens
Experimental: 2
Cataract surgery and implantation of a spherical intraocular lens
Procedure: Cataract surgery and intraocular lens implantation
Cataract surgery and implantation of an intraocular lens

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age-related cataract
  • No indication of existing ocular pathology
  • Unsatisfactory correction with glasses and
  • Less than 2.50 diopters (D) of topography cylinder.

Exclusion Criteria:

  • Previous ocular surgery
  • Central endothelial cell count less than 1800 cells/mm2
  • Glaucoma or intraocular pressure greater than 21 mmHg
  • Amblyopic eyes
  • Retinal abnormalities
  • Diabetes mellitus
  • Steroid or immunosuppressive treatment, and
  • Connective tissue diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576485


Locations
Brazil
Federal University of Minas Gerais - Sao Geraldo Eye Hospital
Belo Horizonte, Minas Gerais, Brazil, 31270000
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Patrick F Tzelikis, MD Federal University of Minas Gerais
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick Frensel de Moraes Tzelikis, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT00576485     History of Changes
Other Study ID Numbers: 490/06
ETIC490/06
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: October 20, 2008
Last Verified: December 2007

Keywords provided by Federal University of Minas Gerais:
Cataract
Intraocular lens
Spherical aberration
Contrast sensitivity

Additional relevant MeSH terms:
Hypersensitivity
Cataract
Signs and Symptoms
Pseudophakia
Lens Diseases
Immune System Diseases
Eye Diseases