An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01004549
First received: October 28, 2009
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.


Condition
Pseudophakia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading [ Time Frame: one study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amplitude of accommodation on pushdown test - and how it compares to the COAS test results [ Time Frame: one study visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bilateral intraocular lens implantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients age 18 and older
  • Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

    • Crystalens
    • Crysalens HD
    • Tecnis One monofocal
  • Patients must have a healthy cornea and macula
  • Patients must have 20/25 or better best corrected vision
  • Able to provide written informed consent

Exclusion Criteria:

  • BCVA of less than 20/25
  • On oral medications that could potentially block accommodation:

    • First generation antihistamines
    • Anticholinergic agents
    • Anti-psychotic medications
    • Antidepressant medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004549

Locations
United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
  More Information

No publications provided

Responsible Party: William Trattler MD, The Center for Excellence in Eye Care
ClinicalTrials.gov Identifier: NCT01004549     History of Changes
Other Study ID Numbers: Accomodation study
Study First Received: October 28, 2009
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Patients who have previously undergone bilateral intraocular lens implantation

Additional relevant MeSH terms:
Pseudophakia
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014