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

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789669
• Other study ID #: CHTA-103-FLAP
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: Study Contact
• Phone: 1-669-252-5145
• Email: cjones56[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a 2-phase, prospective, open-label, comparative (phase II) study design that was chosen for the purpose of optimizing the Cheetah settings (phase I), and evaluating the Cheetah system quality of LASIK flap (phase II).

Description:

This study is a 3-month, 2-phase, prospective, multicenter, open-label, comparative (phase II), randomized (phase II, 1:1 ratio for right and left eyes) study.

The study will be conducted at up to 5 sites and will include up to 30 treated subjects in phase I and up to 300 treated subjects in phase II to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.

Subjects will be enrolled in phase I until Cheetah setting optimization is achieved. After setting optimization, and upon medical monitor and principal investigator consensus, phase II of the study may begin.

For phase I, one eye of each subject will be included (worst seeing eye should be preferred). The investigational Cheetah femtosecond laser and Cheetah patient interface (PI) will be used on one eye to create a LASIK flap. Refractive correction via corneal ablation with a commercial excimer laser will be performed at the investigator's discretion, provided there is at least 1.00 D SE of refractive error. If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.

Once five consecutive phase I subjects show good flap lift, per investigator's evaluation, central flap thickness within ±10 µm of planned thickness, flap diameter within ±0.5 mm of planned diameter, and upon medical monitor and principal investigator consensus, phase II may begin.

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

1. A comparison between the one and two piece PI with the Cheetah system in both eyes. The eye treated with the one piece PI will be the study eye and the eye treated with the two piece PI will be the control eye.

2. A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the one or 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 in phase II 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Phase I of study

INCLUSION CRITERIA

To be considered for enrollment in phase I 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 best corrected vision of 20/50 or worse

• Be available for all scheduled follow-up visits (see below)

EXCLUSION CRITERIA

Subject will not be eligible to take part in phase I 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

• Participating in any other clinical study

Phase II of study

INCLUSION CRITERIA

To be considered for enrollment in phase II 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 in phase II 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

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Cheetah femtosecond laser and Cheetah patient interface
Ophthalmic laser surgical system
• IntraLase iFS iFS femtosecond laser and patient interface
Commercial ophthalmic laser surgical system
• Cheetah femtosecond laser and cheetah patient interface
Ophthalmic laser surgical system

Locations

Country	Name	City	State
India	Narayana Nethralaya Eye Hospital	Rajajinagar	Bangalore
India	Center For Sight	Safdarjung Enclave	New Delhi
Singapore	Tan Tock Seng Hospital PTE. LTD.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Countries where clinical trial is conducted

India,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cheetah ease of flap lift	Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.	Operative day
Primary	surface quality	Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.	Operative Day
Primary	amount of opaque bubble layer (OBL)	Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap.	Operative Day