Clinical Investigation of the Cheetah System For The Correction of Myopia With and Without Astigm… (NCT04200898) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of the Cheetah System For The Correction of Myopia With and Without Astigmatism
Croatia, India, Italy286 participantsStarted 2019-12-31
Plain-language summary
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Note: All criteria apply to each Cheetah treated eye
* Age ≥18 years old at the time of consenting.
* Subjects with refractive error within the following ranges:
* Phase I: Partially sighted eyes (as defined below)
* Phase II: Refractive error range in the Cheetah-treated eye/s between -2.00 D to -6.00 D and astigmatism up to -1.00 D based on manifest refraction at optical infinity. If cyclotorsion correction after docking is available, astigmatism greater than -1. 00 D can be included, provided that spherical equivalent (SE) is up to -6.00 D.
* Phase III: Myopic refractive error in the study eye up to -12.00 D spherical equivalent (SE) and astigmatism up to - 6.00 D based on manifest refraction at optical infinity.
* Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus maximum lenticule thickness to be extracted.
* Uncorrected visual acuity of 20/40 or worse in Phase II and III subjects.
* Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better for phase II and III subjects. For phase I subjects, BSCVA and pin-hole acuity of the iLEX treated eye is worse than 20/50, with at least a 2-line difference between the iLEX treated eye and the fellow eye.
Note: Potential phase I subjects to be evaluated on a case-by-case basis for interocular difference in visual acuity and enrollment to be confirmed through Medical Monitor and PI consensus.
* BSCVA ≥2 lines better than…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The Cheetah System trial has already been completed — do the results suggest this device was effective at correcting myopia and astigmatism, and could my specific prescription fall within the range that showed the best outcomes?
2One of the main things this trial measured was whether patients kept their best corrected vision after the procedure — did any participants lose sharpness that glasses or contacts could previously correct, and what does that mean for my own risk?
3Since this trial is listed as 'Phase NA,' meaning it was studying a device rather than following the usual drug trial phases, how does that affect what we know about long-term safety compared to more established laser vision correction procedures?
4Based on what this trial found about uncorrected vision after the procedure, how likely is it that I might still need glasses or contacts for certain tasks like reading or night driving?
5Would my doctor consider my current prescription, eye health, and lifestyle before recommending this device, and are there standard surgical alternatives I should compare it against before deciding anything?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Monocular Uncorrected Visual Acuity
Timeframe: 1 month
2
maintenance of Best Spectacle Corrected Visual Acuity