Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT00469612
Eligibility Criteria:
Inclusion Criteria:
* Age should be between 18 to 59 years
* Spherical equivalent in the worst eye should not exceed -1.5 DS and the astigmatism should not exceed -0.75 DC.
* The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months. That is, the subject's spectacle prescription should not differ from the auto-refraction value by 0.50D.
* Unaided visual acuity is 0.6 LogMAR or better in the eye with the poorer unaided acuity
* Unaided visual acuity is 0.1 LogMAR or worse in the eye with better unaided acuity
* Unaided visual acuity difference between both eyes is less than 0.3 LogMAR
* Best-corrected visual acuity is 0.04 LogMAR or better in both eyes.
* The subject should be aware that the study has the following features:
1. The recommended pace for the treatment sessions is at least 3 sessions per week.
2. Interruptions should not be longer than 2 weeks during the treatment course. Note: The subject is free to voluntarily withdraw from the study at any time.
Exclusion Criteria:
* The subject suffers from any other visually disabling eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism
* The subject suffers from myopia-related visual complications resulting in visual loss, including myopic macular degeneration, myopic cataract and previous or pre-existing myopic retinal detachment.
* The subject is suffering from Diabetes Mellitus.
* The subject suffers from Migraines
* The subject suffers from Epilepsy
* The subject is pregnant. (It is not recommended to include pregnant women because of the expected visual fluctuations. The NV treatment , basically using a computer, has no impact on the pregnancy.) No pregnancy testing will be done but will be identified through verbal history. The study has use of tropicamide drug (dilation drops) and proparacaine (topical anesthetic), which are a routinely used eye drop in everyday clinical practice and no adverse effects have been reported so far on pregnant women or fetus.
* The subject has an activity limitation due to medical disorders (including migraines, seizure disorders, etc.), medications, or emotional status that might potentially impair the subject's ability to perform the treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT00469612
Study Brief:
Protocol Section:
NCT00469612