New Disposable Contact Lens Patient Interface For The Lensx Laser

Cataract Clinical Trial

Official title:

Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141985
• Other study ID #: CPT-001h
• Status: Completed
• Phase: Phase 0
• First received: June 4, 2010
• Last updated: October 20, 2014
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: LenSx Lasers Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract
• Corneal Disease
• Corneal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Slade and Baker Vision Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LenSx Lasers Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disposable contact lens successfully applied to the eye	Was the Contact Lens successfully applied to the eye? Yes or No.	Intraoperative (Day 0)	No
Secondary	Surgical evaluation of Corneal Incision	Was the corneal incision complete?	Intraoperative (Day 0)	No
Secondary	Standard Outcomes Measurements	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events	Pre-operative (Day -60 to Day -1)	Yes
Secondary	Surgical evaluation of capsulotomy	Was capsulotomy complete? Yes or No.	Intraoperative (Day 0)	No
Secondary	Surgical evaluation of fragmentation	Was lens fragmentation complete? Yes or No.	Intraoperative (Day 0)	No
Secondary	Standard outcomes measurement	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events	1 week (5 to 10 days post operative)	Yes
Secondary	Standard outcomes measurement	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events	1 day (24 to 48 hours postoperative)	Yes
Secondary	Standard outcomes measurement	Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events	1 month (21 to 42 days postoperative)	Yes