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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01382823
Other study ID # FEMTO 2010
Secondary ID
Status Completed
Phase Phase 4
First received June 24, 2011
Last updated October 5, 2011
Start date September 2010
Est. completion date September 2011

Study information

Verified date October 2011
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Femtosecond Laser
Using the Femtosecond Laser to make a clear corneal incision.

Locations

Country Name City State
United States Loden Vision Centers Goodlettsville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular Pressure Measure the fluid pressure inside the eye. three month No
Primary 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). three month No
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