An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses
Completed
- Conditions
- Pseudophakia
- Registration Number
- NCT01004549
- Lead Sponsor
- Innovative Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Amplitude of accommodation on pushdown test - and how it compares to the COAS test results one study visit
Trial Locations
- Locations (1)
The Center for Excellence in Eye Care
🇺🇸Miami, Florida, United States