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

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

Study Overview

• Status: Completed
• Conditions: Pseudophakia

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States
      • The Center for Excellence in Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bilateral intraocular lens implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	one study visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Amplitude of accommodation on pushdown test - and how it compares to the COAS test results	one study visit

Collaborators and Investigators

• Sponsor: Innovative Medical

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 24, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Patients who have previously undergone bilateral intraocular lens implantation
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: Accomodation study