New Disposable Contact Lens Patient Interface For The Lensx Laser

NCT01141985 | Completed Early Phase 1

• 1 other identifier: CPT-001h
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract; Corneal Disease

Keywords

cataract; cornea; keratoplasty

Outcome Measures

Primary Outcomes (1)

• Disposable contact lens successfully applied to the eye

  Was the Contact Lens successfully applied to the eye? Yes or No.

  Intraoperative (Day 0)

Secondary Outcomes (7)

• Surgical evaluation of Corneal Incision

  Intraoperative (Day 0)

• Standard Outcomes Measurements

  Pre-operative (Day -60 to Day -1)

• Surgical evaluation of capsulotomy

  Intraoperative (Day 0)

• Surgical evaluation of fragmentation

  Intraoperative (Day 0)

• Standard outcomes measurement

  1 week (5 to 10 days post operative)

Study Arms (1)

Treated

OTHER

This is a single arm study.

Device: LenSx Laser modified disposable contact lens

Interventions

LenSx Laser modified disposable contact lens DEVICE

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

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LenSx Lasers Inc.: lead

Study Sites (1)

Slade and Baker Vision Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Cataract; Corneal Diseases

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Stephen Slade, MD

  Slade and Baker Vision Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 11, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

US (1)