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Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Primary Purpose

Cataracts

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Femtosecond Laser

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

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

Sites / Locations

Loden Vision Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Femtosecond Laser

Arm Description

Outcomes

Primary Outcome Measures

Intraocular Pressure

Measure the fluid pressure inside the eye

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01383057

First Posted

June 24, 2011

Last Updated

February 15, 2012

Sponsor

Innovative Medical

1. Study Identification

Unique Protocol Identification Number

NCT01383057

Brief Title

Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Official Title

Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovative Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataracts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Femtosecond Laser

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Femtosecond Laser

Intervention Description

Using the Femtosecond Laser to make a clear corneal incision.

Primary Outcome Measure Information:

Title

Intraocular Pressure

Description

Measure the fluid pressure inside the eye

Time Frame

3 months

Title

Uncorrected and Best corrected Visual Acuity

Description

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

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Loden Vision Centers

City

Goodlettsville

State/Province

Tennessee

Country

United States

12. IPD Sharing Statement

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Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

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