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

Pseudophakia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004549
• Other study ID #: Accomodation study
• 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

• Pseudophakia

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