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Spherical Aberration and Contrast Sensitivity in IOLs

This study has been completed.
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00576485
First received: December 18, 2007
Last updated: October 17, 2008
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Federal University of Minas Gerais

Additional 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
Study First Received: December 18, 2007
Last Updated: October 17, 2008
Health Authority: Brazil: National Health Surveillance Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013