NCT01004549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

October 28, 2009

Last Update Submit

June 24, 2011

Conditions

Pseudophakia

Keywords

Patients who have previously undergone bilateral intraocular lens implantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Amplitude of accommodation on pushdown test - and how it compares to the COAS test results

    one study visit

Study Arms (1)

Bilateral intraocular lens implantation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patients age 18 and older
  • 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

You may not qualify if:

  • BCVA of less than 20/25
  • On oral medications that could potentially block accommodation:
  • First generation antihistamines
  • Anticholinergic agents
  • Anti-psychotic medications
  • Antidepressant medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Excellence in Eye Care

Miami, Florida, United States

Location

MeSH Terms

Conditions

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Trattler, MD

    The Center for Excellence in Eye Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 30, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

US(1)