New Disposable Contact Lens Patient Interface For The Lensx Laser

Early Phase 1

Completed

• Conditions: Cataract; Corneal Disease
• Interventions: Device: LenSx Laser modified disposable contact lens

• Registration Number: NCT01141985
• Lead Sponsor: LenSx Lasers Inc.

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. Subjects will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition.

Subjects will undergo unilateral cataract surgery using the LenSx Laser for one or a combination of the following laser procedures: anterior capsulotomy, laser lens phacofragmentation and corneal incision with implantation of an intraocular lens (IOL). Surgeon and staff comments will be solicited for ergonomic and packaging features of the new disposable contact lens. Subjects will be evaluated intraoperatively to assess comfort of the new disposable contact lens, as well as the completion of anterior capsulotomy, laser lens phacofragmentation and completion of corneal incisions. All patients will be evaluated postoperatively at one day, one week and 1 month to follow the condition of the surgical eye. Further follow up can be performed at the discretion of the surgeon.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
2. Subjects must be at least 24 years of age.
3. Subjects must be willing and able to return for scheduled follow-up examinations.
4. Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria

1. Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light are excluded.
2. Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
3. 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.
4. Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>21 mm Hg in either eye are excluded.
5. Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
6. 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.
7. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study are excluded.
8. Subjects with known sensitivity to planned study concomitant medications are excluded.
9. Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation are excluded
10. Subjects presenting any contraindications to cataract surgery are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated	LenSx Laser modified disposable contact lens	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Disposable contact lens successfully applied to the eye	Intraoperative (Day 0)	Was the Contact Lens successfully applied to the eye? Yes or No.

Secondary Outcome Measures

Name	Time	Method
Surgical evaluation of Corneal Incision	Intraoperative (Day 0)	Was the corneal incision complete?
Surgical evaluation of capsulotomy	Intraoperative (Day 0)	Was capsulotomy complete? Yes or No.
Surgical evaluation of fragmentation	Intraoperative (Day 0)	Was lens fragmentation complete? Yes or No.
Standard outcomes measurement	1 month (21 to 42 days postoperative)	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Standard Outcomes Measurements	Pre-operative (Day -60 to Day -1)	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events

Trial Locations

Locations (1)

Slade and Baker Vision Center; 🇺🇸 Houston, Texas, United States