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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004549
Other study ID # Accomodation study
Secondary ID
Status Completed
Phase N/A
First received October 28, 2009
Last updated June 24, 2011
Start date October 2009
Est. completion date June 2011

Study information

Verified date June 2011
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Center for Excellence in Eye Care Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Amplitude of accommodation on pushdown test - and how it compares to the COAS test results one study visit No
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