Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
NCT00845520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2018-07-06
Summary
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.
Conditions
- Cataracts
Interventions
- DEVICE
-
Lens implantation +1.00 D postop target
Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
- DEVICE
-
Lens implantation -1.00 D postop target
Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
- DEVICE
-
Lens implantation 0.00 D postop target
Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Sponsors & Collaborators
-
Calhoun Vision, Inc.
lead INDUSTRY
Principal Investigators
-
R. Doyle Stulting, MD, PhD · Emory Eye Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
- Mexico
Study Locations
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