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
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: 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 July 23, 2014