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
  Purpose

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


Condition Intervention Phase
Cataract
Corneal Disease
Device: LenSx Laser modified disposable contact lens
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery

Resource links provided by NLM:


Further study details as provided by LenSx Lasers Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 110
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treated
This is a single arm study.
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.

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.

  Eligibility

Ages Eligible for Study:   24 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141985

Locations
United States, Texas
Slade and Baker Vision Center
Houston, Texas, United States, 77027
Sponsors and Collaborators
LenSx Lasers Inc.
Investigators
Principal Investigator: Stephen Slade, MD Slade and Baker Vision Center
  More Information

No publications provided

Responsible Party: LenSx Lasers Inc.
ClinicalTrials.gov Identifier: NCT01141985     History of Changes
Other Study ID Numbers: CPT-001h
Study First Received: June 4, 2010
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by LenSx Lasers Inc.:
cataract
cornea
keratoplasty

Additional relevant MeSH terms:
Cataract
Corneal Diseases
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 22, 2014