Status:
COMPLETED
New Disposable Contact Lens Patient Interface For The Lensx Laser
Lead Sponsor:
LenSx Lasers Inc.
Conditions:
Cataract
Corneal Disease
Eligibility:
All Genders
24+ years
Phase:
EARLY_PHASE1
Brief Summary
The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.
Detailed Description
This will be a prospective, single center clinical trial of up to 300 consecutive eyes of subjects scheduled to undergo ocular surgery requiring an initial incision, specifically, cataract surgery. Su...
Eligibility Criteria
Inclusion
- Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
- Subjects must be at least 24 years of age.
- Subjects must be willing and able to return for scheduled follow-up examinations.
- Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion
- Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light are excluded.
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
- Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
- Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>21 mm Hg in either eye are excluded.
- Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye are excluded.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study are excluded.
- Subjects with known sensitivity to planned study concomitant medications are excluded.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation are excluded
- Subjects presenting any contraindications to cataract surgery are excluded.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01141985
Start Date
February 1 2010
End Date
December 1 2010
Last Update
October 22 2014
Active Locations (1)
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1
Slade and Baker Vision Center
Houston, Texas, United States, 77027