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

Primary Purpose

Refractive Error

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cheetah femtosecond laser and Cheetah patient interface
IntraLase iFS iFS femtosecond laser and patient interface
Cheetah femtosecond laser and cheetah patient interface
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

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

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

Sites / Locations

  • Narayana Nethralaya Eye HospitalRecruiting
  • Center For SightRecruiting
  • Tan Tock Seng Hospital PTE. LTD.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Investigational

Investigational/Control

Control/Investigational

Arm Description

In phase I the investigators will use the investigational Cheetah femtosecond laser and Cheetah patient interface (PI) on one eye to create a LASIK flap (worst seeing eye should be preferred). Refractive correction via corneal ablation with a commercial excimer laser will be performed at the discretion of the investigator.If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.

In phase II, 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 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 will be used on both eyes).

In phase II, 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 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 will be used on both eyes).

Outcomes

Primary Outcome Measures

Cheetah ease of flap lift
Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.
surface quality
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.
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.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2018
Last Updated
October 10, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03789669
Brief Title
A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Official Title
A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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 250 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 investigational Cheetah femtosecond laser and Cheetah PI will be used 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) and will be considered the study 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational
Arm Type
Experimental
Arm Description
In phase I the investigators will use the investigational Cheetah femtosecond laser and Cheetah patient interface (PI) on one eye to create a LASIK flap (worst seeing eye should be preferred). Refractive correction via corneal ablation with a commercial excimer laser will be performed at the discretion of the investigator.If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.
Arm Title
Investigational/Control
Arm Type
Active Comparator
Arm Description
In phase II, 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 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 will be used on both eyes).
Arm Title
Control/Investigational
Arm Type
Active Comparator
Arm Description
In phase II, 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 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 will be used on both eyes).
Intervention Type
Device
Intervention Name(s)
Cheetah femtosecond laser and Cheetah patient interface
Intervention Description
Ophthalmic laser surgical system
Intervention Type
Device
Intervention Name(s)
IntraLase iFS iFS femtosecond laser and patient interface
Intervention Description
Commercial ophthalmic laser surgical system
Intervention Type
Device
Intervention Name(s)
Cheetah femtosecond laser and cheetah patient interface
Intervention Description
Ophthalmic laser surgical system
Primary Outcome Measure Information:
Title
Cheetah ease of flap lift
Description
Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.
Time Frame
Operative day
Title
surface quality
Description
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.
Time Frame
Operative Day
Title
amount of opaque bubble layer (OBL)
Description
Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap.
Time Frame
Operative Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
+1 714 247-8802
Email
DParizad@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Narayana Nethralaya Eye Hospital
City
Rajajinagar
State/Province
Bangalore
ZIP/Postal Code
560010
Country
India
Individual Site Status
Recruiting
Facility Name
Center For Sight
City
Safdarjung Enclave
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital PTE. LTD.
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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