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| Name | Class |
|---|---|
| Universidad Europea de Madrid | OTHER |
| Aston University | OTHER |
| Clinica novovision | UNKNOWN |
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The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menicon Z Night | Experimental | The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years |
|
| Glasses | Active Comparator | The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menicon Z Night | Device | To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | To compare the incidence of adverse events between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Adverse events were classified into serious, significant, or non-significant. Recurrences of the same adverse event(s) in the same or fellow eye at any of the subsequent study visits were classified as separate events; bilateral events will be counted as two separate events. The incidence of adverse events was calculated as a percentage of eyes per annum. |
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Inclusion Criteria:
Exclusion Criteria:
White European
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22729437 | Result | Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005. | |
| 22773180 | Result | Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Orthokeratology vs. spectacles: adverse events and discontinuations. Optom Vis Sci. 2012 Aug;89(8):1133-9. doi: 10.1097/OPX.0b013e318263c5af. |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Prospective, controlled, longitudinal
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| Control | Device | Distance, single-vision glasses were used as control |
|
| Two years |
| Patient-reported outcomes | To compare vision-related quality-of-life measures between children wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. The pediatric refractive error profile survey was used to compare patient-reported outcomes in terms of the vision-specific quality of life between children in the Menicon Z Night and control groups. The survey consists of 26 statements scored from 1 (poor quality of life) to 5 (good quality of life), then scaled from 0 to 100 by subtracting 1 from the raw score of each question and multiplying by 25. The mean score of all items was calculated as the overall score. The survey includes 11 scales: overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academics, handling, peer perception, and overall score. | Two years |
| 23392299 | Result | Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: a comparison of vision-related quality-of-life measures between orthokeratology contact lenses and single-vision spectacles. Eye Contact Lens. 2013 Mar;39(2):153-7. doi: 10.1097/ICL.0b013e31827a0241. |