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OpenTrials
Completed

NCT Number: NCT01713660

Corneal Incisions With the IntraLase iFS Femtosecond Laser System

The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 21 years of age
  • Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
  • Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
  • Clear intraocular media other than cataract
  • Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
  • Signed informed consent

Exclusion criteria

  • Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
  • History of active or recurrent ophthalmic disease
  • Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
  • White to white measurement less than 10 mm or greater than 14 mm
  • Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
  • Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
  • Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
  • Subjects with conditions associated with increased risk of IOL/capsule instability
  • Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities
  • Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)
  • History of any ocular or medical conditions that could affect corneal wound healing
  • Poorly-controlled diabetes or subjects with diabetic retinopathy
  • Concurrent use of topical or systemic medications that may impair corneal wound healing
  • Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
  • Ocular hypertension (> 21 mm Hg)
  • Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course
  • Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit

Treatment and study plan

iFS Femtosecond Laser

Device

corneal incisions created by the femtosecond laser

Primary outcomes

  1. Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.

    Time frame: Day 0, Operative (Within 2 hours of incision creation)

    Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).

Secondary outcomes

  1. Surgeon Assessment of Workflow

    Time frame: Day 0, Operative

    Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?

  2. Percent of Seidel Staining

    Time frame: Day 0 (performed immediately post-incision creation), Day 1

    Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Oct 25, 2012
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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