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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00348218
Eligibility Criteria:
Inclusion Criteria:
1. The subject's age is between 7 to 9 years.
2. The subject's cycloplegic refraction is at least -1.0DS in either eye.
3. The subject's manifest spherical equivalence does not differ by more than 1.0 D from cycloplegic spherical equivalence
4. The subject's visual acuity with an under correction of 1DS (compared to the manifest subjective VA), in both eyes, should not exceed 0.6 LogMAR.
5. The subject's best corrected visual acuity 0.04 LogMAR (either eye)
6. The subject is cognitively intact and is able to follow multiple step instructions.
7. The subject and his parents/legal guardians are very keen to improve the habitual visual acuity and to reduce the progression rate of myopia
8. The subject is able and willing to attend all study sessions and visits at the required frequency:
* The total number of treatments is individual, approximately 30 and no more than 40.
* The required pace for the treatment sessions is at least 3 sessions per week.
* No foreseen interruptions longer than 2 weeks during the treatment course.
9. The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period (phase I).
10. The subject's parent/legal guardian agrees to sign the Informed Consent Form (See Appendix D)
11. Subject's parent/legal guardian agrees to follow the study instruction including use of optical aids
Exclusion Criteria:
1. The subject suffers from any other eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism.
2. 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.
3. The subject is suffering from Diabetes Mellitus.
4. The subject suffers from binocular vision problems, such as high exophoria / divergent squint / nystagmus
5. 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:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
9 Years
Study:
NCT00348218
Study Brief:
Protocol Section:
NCT00348218