Skip to main content
OpenTrials
Completed

NCT Number: NCT01382823

Laser Cataract Surgery With the Femtosecond Laser Technology

The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loden Vision Centers

Goodlettsville, Tennessee, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
  • Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
  • The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.

Exclusion criteria

  • Concurrent participation or participation in the last 30 days in other clinical trials.
  • Known steroid IOP responder.
  • Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.).
  • Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.).
  • Uncontrolled systemic or ocular disease.
  • Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies)
  • Pseudoexfoliation.
  • Ocular hypertension (>or =20hg) or glaucomatous changes in the optic nerve.

Treatment and study plan

Femtosecond Laser

Procedure

Using the Femtosecond Laser to make a clear corneal incision.

Primary outcomes

  1. Intraocular Pressure

    Time frame: three month

    Measure the fluid pressure inside the eye.

  2. Uncorrected and Best corrected Visual Acuity

    Time frame: three month

    Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Oct 6, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.