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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational/Control | Active Comparator | 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). |
|
| Control/Investigational | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntraLase iFS femtosecond laser and patient interface | Device | Commercial ophthalmic laser surgical system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stromal Bed Surface Quality | Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher. | At the Operative visit, one time visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Flap Thickness | The central flap thickness is measured per each eye, compared from ELITA vs. iFS performances. | 3 months |
INCLUSION CRITERIA
To be considered for enrollment of the study, subject must:
EXCLUSION CRITERIA
Subject will not be eligible to take part of the study if subject, use or have:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narayana Nethralaya Eye Hospital | RajajiNagar | Bangalore | 560010 | India | ||
| Center For Sight |
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A total of 200 subjects were enrolled in the study. 45 subjects were consented but not treated in the study. 3 subjects were one-eye treated with ELITA; and 197 subjects were treated bilateral (one eye treated with ELITA, one eye treated with controlled system iFS). 3 unilaterally treated subjects were excluded from the analysis. A score of 4 or 5: study eye was better than the control eye. A score of 3: equal performance. A score of 1 or 2: study eye was worse than the control eye.
This is a paired-eye study design in which for each subject, one eye is treated with ELITA and the fellow eye is treated with iFS. For the primary endpoints, a relative scale of 1-5 was used to compare the performance of the ELITA treated eye vs iFS treated eye. The primary endpoint evaluations require both eyes to be treated; thus, 3 unilaterally treated subjects were excluded from the analysis. There is only one arm for primary endpoint evaluation; and two arms for other analyses.
| ID | Title | Description |
|---|---|---|
| FG000 | Unilateral | ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated |
| FG001 | Bilateral | One eye treated with ELITA, fellow eye treated with iFS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2023 | Sep 27, 2024 |
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| Cheetah femtosecond laser and cheetah patient interface | Device | Ophthalmic laser surgical system |
|
| Safdarjung Enclave |
| New Delhi |
| 110029 |
| India |
| Tan Tock Seng Hospital PTE. LTD. | Singapore | 308433 | Singapore |
| COMPLETED |
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| NOT COMPLETED |
|
3 unilaterally treated subjects were excluded in analysis as they were not applicable.
| ID | Title | Description |
|---|---|---|
| BG000 | Unilateral | ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated |
| BG001 | Bilateral | One eye treated with ELITA, fellow eye treated with iFS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stromal Bed Surface Quality | Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher. | 3 unilaterally treated subjects were excluded from the analysis. There is only one arm analyzed for primary outcome measure. The primary endpoint evaluations require both eyes to be treated. | Posted | Count of Units | Eyes | At the Operative visit, one time visit | Eyes | Eyes |
|
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| Other Pre-specified | Flap Thickness | The central flap thickness is measured per each eye, compared from ELITA vs. iFS performances. | This Outcome Measure has different Group from the Outcome Measure 1, Test Group with one eye with ELITA and Control Group, the fellow eye with the iFS. At 3-month visit, there were only 132 participants in the analysis. These data were not collected from participants in the Unilateral group. | Posted | Mean | Standard Deviation | microMeter | 3 months | Eyes | Eyes |
|
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During the course of the study until termination (3 months)
Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level.
3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilateral | One eye treated with ELITA only, Fellow Eye Not Treated | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Bilateral | One eye treated with ELITA, fellow eye treated with iFS | 0 | 197 | 0 | 197 | 2 | 197 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscreated Flap | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Epithelium in the interface with a loss of 2 or more lines of BSCVA (>10 ETDRS letters) | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Other | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, Dr. | Johnson & Johnson Surgical Vision | +1 904 6292289 | bpall@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2023 | Sep 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
|
| 30-39 years old |
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| <30 years old |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Eyes |
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