A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational 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. |
Device: Cheetah femtosecond laser and Cheetah patient interface
Ophthalmic laser surgical system
|
| Active Comparator: Investigational/Control 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). |
Device: Cheetah femtosecond laser and cheetah patient interface
Ophthalmic laser surgical system
|
| Active Comparator: Control/Investigational 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). |
Device: IntraLase iFS iFS femtosecond laser and patient interface
Commercial ophthalmic laser surgical system
|
Outcome Measures
Primary Outcome Measures
- Cheetah ease of flap lift [Operative day]
Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.
- surface quality [Operative Day]
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.
- amount of opaque bubble layer (OBL) [Operative Day]
Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center For Sight | Safdarjung Enclave | New Delhi | India | 110029 |
| 2 | Tan Tock Seng Hospital PTE. LTD. | Singapore | Singapore | 308433 |
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
Investigators
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHTA-103-FLAP