NCT01383057

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

June 24, 2011

Last Update Submit

February 15, 2012

Conditions

Cataracts

Outcome Measures

Primary Outcomes (2)

  • Intraocular Pressure

    Measure the fluid pressure inside the eye

    3 months

  • Uncorrected and Best corrected Visual Acuity

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

    one month

Study Arms (1)

Femtosecond Laser

EXPERIMENTAL
Procedure: Femtosecond Laser

Interventions

Femtosecond LaserPROCEDURE

Using the Femtosecond Laser to make a clear corneal incision.

Femtosecond Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.

You may not qualify if:

  • Concurrent participation or participation in the last thirty days in any other clinical trial.
  • Known steroid IOP responder
  • Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, 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 IOP \>25 mmHg by tonometry or glaucomatous changes in the optic nerve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loden Vision Centers

Goodlettsville, Tennessee, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 28, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)