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Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm 1 | Experimental | Single vision, impact-resistant spectacle lenses |
|
| Test Arm 2 | Experimental | Single vision, impact-resistant spectacle lenses |
|
| Test Arm 3 | Other | Single vision, impact-resistant spectacle lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel spectacle lens design | Device | Use of lenses may reduce the rate of progression of juvenile myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Change in axial length from baseline | 36 Months |
| Spherical equivalent refraction | Change in spherical equivalent refraction from baseline | 36 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Rappon, OD, MS, FAAO | SightGlass Vision, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Sabal Eye Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36126105 | Derived | Rappon J, Chung C, Young G, Hunt C, Neitz J, Neitz M, Chalberg T. Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). Br J Ophthalmol. 2023 Nov;107(11):1709-1715. doi: 10.1136/bjo-2021-321005. Epub 2022 Sep 1. |
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Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
| Spectacle lenses | Device | Use of lenses may reduce the rate of progression of juvenile myopia |
|
| Longwood |
| Florida |
| 32779 |
| United States |
| Visual Performance Center | Pensacola | Florida | 32503 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept | West Monroe | Louisiana | 71291 | United States |
| Advanced Eyecare, PC | Raytown | Missouri | 64133 | United States |
| SUNY School of Optometry | New York | New York | 10036 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Dept of Clinical Research, South Shore Eye Care, LLP | Wantagh | New York | 11793 | United States |
| Dunes Eye Consultants | Dakota Dunes | South Dakota | 57049 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
| William J Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
| Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science | Waterloo | Ontario | N2L 3G1 | Canada |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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