A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
Myopia
About this trial
This is an interventional treatment trial for Myopia focused on measuring Neurovision, Adult myopia, Therapy
Eligibility Criteria
Inclusion Criteria for Phase I NVC-AM1 (Low Myopia): The subject's cycloplegic spherical equivalence in the worst eye is within the range of -0.50DS to -1.50DS of myopia, and astigmatism does not exceed 0.75DC in either eye. The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months. The subject's age is between 17-55 years. The subject's uncorrected visual acuity in both eyes should be between 0.1 and 0.7 logMAR. The subject's best corrected visual acuity 0.05 LogMar (either eye) The subject is cognitively intact and is able to follow multiple step instructions. The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period. The subject is able to cease contact lens wear for at least a week before attending the Baseline examination, Post-treatment evaluation and Persistence evaluation. 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. 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. Subject (or subject's parent/legal guardian if subject is less than 21 years of age at study entry) agrees to sign the Informed Consent Form (See Appendix D) Manifest spherical equivalence - not more than 1.0Ds difference from cycloplegic spherical equivalence Unaided VA difference between both eyes is less than 0.3 logMAR The patient is very keen to improve unaided vision and to decrease the dependency on eye glasses Inclusion criteria for Phase II NVC-AM2 (Moderate Myopia): The subject's cycloplegic spherical equivalence in the worst eye is within the range of -1.750DS to -3.0DS of myopia, and astigmatism does not exceed 0.75DC in either eye. The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months. The subject's age is between 17-55 years. The subject's uncorrected visual acuity in the worst eye should not exceed 1.0 logMAR. The subject's best corrected visual acuity 0.05 LogMar (either eye) The subject is cognitively intact and is able to follow multiple step instructions. The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period. The subject is able to cease contact lens wear for at least a week before attending the Baseline examination, Post-treatment evaluation and Persistence evaluation. 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. 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. Subject (or subject's parent/legal guardian if subject is less than 21 years of age at study entry) agrees to sign the Informed Consent Form (See Appendix D) Exclusion Criteria (for both Phase I and II): The subject suffers from any other 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 has previously undergone a refractive surgery procedure in either eye. The subject is or may be pregnant. 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.
Sites / Locations
- Singapore Eye Research Institute
Arms of the Study
Arm 1
Experimental
Neurovision