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Laser Cataract Surgery With the Femtosecond Laser Technology

NCT ID: NCT01382823

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femtosecond Laser

Group Type EXPERIMENTAL

Femtosecond Laser

Intervention Type PROCEDURE

Using the Femtosecond Laser to make a clear corneal incision.

Interventions

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Femtosecond Laser

Using the Femtosecond Laser to make a clear corneal incision.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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CRO

Principal Investigators

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James Loden, MD

Role: PRINCIPAL_INVESTIGATOR

Loden Vision Centers

Locations

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Loden Vision Centers

Goodlettsville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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FEMTO 2010

Identifier Type: -

Identifier Source: org_study_id