Status:
COMPLETED
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
Lead Sponsor:
Calhoun Vision, Inc.
Conditions:
Cataracts
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
- Adults between the ages of 40 and 80 inclusive.
- Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
- Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
- Clear intraocular media other than cataract.
- Potentially good vision in the fellow eye with BCVA 20/40 or better.
- Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
- Fully dilated pupil diameter of more than or equal to 7.0 mm.
Exclusion
- Zonular laxity or dehiscence.
- Pseudoexfoliation.
- Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder that is expected to cause future vision loss.
- Diabetes with any evidence of retinopathy.
- Evidence of glaucomatous optic neuropathy.
- History of uveitis.
- Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
- Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
- Keratoconus or suspected of having keratoconus.
- Corneal dystrophy including basement membrane dystrophy.
- Previous corneal or intraocular surgery
- Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
- Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00845520
Start Date
January 1 2009
End Date
March 1 2013
Last Update
July 6 2018
Active Locations (6)
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1
Altos Eye Physicians
Los Altos, California, United States, 94024
2
Maloney Vision Institute
Los Angeles, California, United States, 90024
3
Price Vision Group
Indianapolis, Indiana, United States, 46260
4
Discover Vision Centers
Leawood, Kansas, United States, 66211