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
  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:


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
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: 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:
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 July 28, 2014