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This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error.
Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SV 1 | Active Comparator | Single vision lenses |
|
| SV 2 | Active Comparator | Single vision lenses |
|
| MyoCare | Experimental | ZEISS MyoCare spectacle lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZEISS MyoCare spectacle lenses | Device | Spectacle lenses with conventional power profile including myopia control design. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wearability | Visual acuity with study spectacle lenses | Day 1 At dispensing visit, 3 months and 6 months visits |
| Wearability | Subjective responses measured by a wearability questionnaire (scale 1-10, with 1 being the worst and 10 being the best) regarding study spectacle lenses wear | Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits |
| Wearability | Compliance (lens wearing time, hr/day) to study spectacle lenses wear | At 1-week, 2-week, 3 months and 6 months visits |
| Measure | Description | Time Frame |
|---|---|---|
| Myopia progression | The 6 monthly myopia progression measured by change in spherical equivalent from baseline for each of the study groups. | At baseline and 6 months visits |
| Myopia progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Liu, MBBS, MOptom, PhD | Contact | +61 413759820 | xiao.liu@zeiss.com |
| Name | Affiliation | Role |
|---|---|---|
| Chi Hoang Viet Vu, MD | Hanoi Eye Hospital 2 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Eye Hospital 2 | Recruiting | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ZEISS SV RX SPH 1.5 | Device | Commercially available single vision |
|
| ZEISS Clearview | Device | Commercially available single vision |
|
The 6 monthly myopia progression measured by change in axial length from baseline for each of the study groups.
| At baseline, 3 months, and 6 months visits |