A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is a prospective, open-label, comparative study design that was chosen for the purpose of optimizing the Cheetah settings, and evaluating the Cheetah system quality of LASIK flap.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Corneal Incisions With the IntraLase iFS Femtosecond Laser System

NCT01713660

Cataract

COMPLETED NA

Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

NCT07036835

Refractive Errors

RECRUITING NA

Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes

NCT04699266

Cataract Lens Opacities Presbyopia

COMPLETED NA

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

NCT01383057

Cataracts

COMPLETED PHASE4

Femtosecond Laser Versus Microkeratome in Creating Corneal Flaps in LASIK

NCT03484468

Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a 3-month, prospective, multicenter, open-label, comparative, randomized (1:1 ratio for right and left eyes) study.

The study will be conducted at up to 5 sites and up to 300 treated subjects to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.

Both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed:

A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the two piece PI) on the other eye. The eye treated with the Cheetah femtosecond laser will be the study eye and the eye treated with the commercial iFS femtosecond laser will be the control eye.

All procedures will be performed to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The study eye will be randomized (ratio of 1:1 for right eye and left eye).

Subjects will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system shall be used on both eyes).

Over the course of the study, minor prototype device settings/improvements (with no safety implications and without compromising the clinical validity of the study) may be performed to optimize the quality of flap.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractive Error

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Investigational/Control

Both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).

Subjects will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).

Group Type ACTIVE_COMPARATOR

IntraLase iFS femtosecond laser and patient interface

Intervention Type DEVICE

Commercial ophthalmic laser surgical system

Control/Investigational

Both eyes of each subject will be treated. The investigators will use the commercial Cheetah femtosecond laser and Cheetah two piece PI on one eye, and commercial Cheetah femtosecond laser and investigational Cheetah to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).

Subjects will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).

Group Type ACTIVE_COMPARATOR

Cheetah femtosecond laser and cheetah patient interface

Intervention Type DEVICE

Ophthalmic laser surgical system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IntraLase iFS femtosecond laser and patient interface

Commercial ophthalmic laser surgical system

Intervention Type DEVICE

Cheetah femtosecond laser and cheetah patient interface

Ophthalmic laser surgical system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

To be considered for enrollment of the study, subject must:

* Sign an informed consent and HIPAA authorization
* Be at least 18 years of age at the time of study exam
* Have refractive error and be eligible for commercial LASIK treatment
* Be available for all scheduled follow-up visits (see below)

Exclusion Criteria

Subject will not be eligible to take part of the study if subject, use or have:

* Known to be pregnant, breastfeeding or intend to become pregnant during the study.
* Recent ocular (eye) trauma or eye surgery
* A history of or active ophthalmic (eye) disease or abnormality
* Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions
* A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis.
* Cardiac pacemaker, implanted defibrillator or other implanted electronic device
* Taking systemic or inhaled medications that may affect wound healing
* Known sensitivity or inappropriate responsiveness to any of the medications used in the study
* Desire for monovision correction
* Participating in any other clinical study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No