New Disposable Contact Lens Patient Interface For The Lensx Laser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LenSx Lasers Inc.
ClinicalTrials.gov Identifier:
NCT01141985
First received: June 4, 2010
Last updated: October 20, 2014
Last verified: October 2014

June 4, 2010
October 20, 2014
February 2010
December 2010   (final data collection date for primary outcome measure)
Disposable contact lens successfully applied to the eye [ Time Frame: Intraoperative (Day 0) ] [ Designated as safety issue: No ]
Was the Contact Lens successfully applied to the eye? Yes or No.
Not Provided
Complete list of historical versions of study NCT01141985 on ClinicalTrials.gov Archive Site
  • Surgical evaluation of Corneal Incision [ Time Frame: Intraoperative (Day 0) ] [ Designated as safety issue: No ]
    Was the corneal incision complete?
  • Standard Outcomes Measurements [ Time Frame: Pre-operative (Day -60 to Day -1) ] [ Designated as safety issue: Yes ]
    Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
  • Surgical evaluation of capsulotomy [ Time Frame: Intraoperative (Day 0) ] [ Designated as safety issue: No ]
    Was capsulotomy complete? Yes or No.
  • Surgical evaluation of fragmentation [ Time Frame: Intraoperative (Day 0) ] [ Designated as safety issue: No ]
    Was lens fragmentation complete? Yes or No.
  • Standard outcomes measurement [ Time Frame: 1 week (5 to 10 days post operative) ] [ Designated as safety issue: Yes ]
    Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
  • Standard outcomes measurement [ Time Frame: 1 day (24 to 48 hours postoperative) ] [ Designated as safety issue: Yes ]
    Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
  • Standard outcomes measurement [ Time Frame: 1 month (21 to 42 days postoperative) ] [ Designated as safety issue: Yes ]
    Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
Not Provided
Not Provided
Not Provided
 
New Disposable Contact Lens Patient Interface For The Lensx Laser
Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery

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

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.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Cataract
  • Corneal Disease
Device: LenSx Laser modified disposable contact lens
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.
Treated
This is a single arm study.
Intervention: Device: LenSx Laser modified disposable contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
24 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141985
CPT-001h
No
LenSx Lasers Inc.
LenSx Lasers Inc.
Not Provided
Principal Investigator: Stephen Slade, MD Slade and Baker Vision Center
LenSx Lasers Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP