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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01383057

Enrollment

Registered

2011-06-28

Start date

2011-06-30

Completion date

2012-02-29

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataracts

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.

Interventions

PROCEDUREFemtosecond Laser

Using the Femtosecond Laser to make a clear corneal incision.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Intraocular Pressure	3 months	Measure the fluid pressure inside the eye
Uncorrected and Best corrected Visual Acuity	one month	Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026