Back to resultsNew Disposable Contact Lens Patient Interface For The Lensx Laser
Primary Purpose
Cataract, Corneal Disease
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
LenSx Laser modified disposable contact lens
Sponsored by
About this trial
This is an interventional basic science trial for Cataract focused on measuring cataract, cornea, keratoplasty
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Slade and Baker Vision Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treated
Arm Description
This is a single arm study.
Outcomes
Primary Outcome Measures
Disposable contact lens successfully applied to the eye
Was the Contact Lens successfully applied to the eye? Yes or No.
Secondary Outcome Measures
Surgical evaluation of Corneal Incision
Was the corneal incision complete?
Standard Outcomes Measurements
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Surgical evaluation of capsulotomy
Was capsulotomy complete? Yes or No.
Surgical evaluation of fragmentation
Was lens fragmentation complete? Yes or No.
Standard outcomes measurement
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Standard outcomes measurement
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Standard outcomes measurement
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01141985
Brief Title
New Disposable Contact Lens Patient Interface For The Lensx Laser
Official Title
Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LenSx Lasers Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Corneal Disease
Keywords
cataract, cornea, keratoplasty
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated
Arm Type
Other
Arm Description
This is a single arm study.
Intervention Type
Device
Intervention Name(s)
LenSx Laser modified disposable contact lens
Intervention Description
Modified Disposable Contact Lens Patient Interface: Like the current disposable contact lens, a single unit is used for each procedure only once, and is then discarded. It is similarly mounted onto the distal end of the system's focusing objective and serves as a sterile barrier between the patient and the laser. In place of a separate suction ring that is used in the current contact lens, the modified contact lens has an integrated suction ring and curved applanation surface. These features result in significantly lower elevation of intraocular pressure and significantly easier application by the surgeon in preliminary testing. Identical to the current contact lens, the suction ring is applied around the patient's limbus and mild suction is applied to stabilize the eye.
Primary Outcome Measure Information:
Title
Disposable contact lens successfully applied to the eye
Description
Was the Contact Lens successfully applied to the eye? Yes or No.
Time Frame
Intraoperative (Day 0)
Secondary Outcome Measure Information:
Title
Surgical evaluation of Corneal Incision
Description
Was the corneal incision complete?
Time Frame
Intraoperative (Day 0)
Title
Standard Outcomes Measurements
Description
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Time Frame
Pre-operative (Day -60 to Day -1)
Title
Surgical evaluation of capsulotomy
Description
Was capsulotomy complete? Yes or No.
Time Frame
Intraoperative (Day 0)
Title
Surgical evaluation of fragmentation
Description
Was lens fragmentation complete? Yes or No.
Time Frame
Intraoperative (Day 0)
Title
Standard outcomes measurement
Description
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Time Frame
1 week (5 to 10 days post operative)
Title
Standard outcomes measurement
Description
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Time Frame
1 day (24 to 48 hours postoperative)
Title
Standard outcomes measurement
Description
Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Time Frame
1 month (21 to 42 days postoperative)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Slade, MD
Organizational Affiliation
Slade and Baker Vision Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slade and Baker Vision Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
12. IPD Sharing Statement
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New Disposable Contact Lens Patient Interface For The Lensx Laser
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