New Disposable Contact Lens Patient Interface For The Lensx Laser

Completed · Early Phase 1

Conditions studied: Cataract, Corneal Disease

In brief

The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.

Key facts

Study ID

NCT01141985

Run by

LenSx Lasers Inc.

People needed

110

Starts

2010-02-01

Expected to finish

2010-12-01

Last updated by the study team

2014-10-22

Who can join

Age: 24 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Slade and Baker Vision Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.