Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-25-03-051757 | Other Identifier | INFARMED (Portugal) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software.
Two different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB).
The software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.
The goal of the investigation is to evaluate the accuracy of the Kids refraction software results performed with the phoropters Vision-R™700 and Vision-S™700 compared to the conventional subjective refraction method results performed with Vision-R™700. Phase A of the investigation will focus on the validation of the first version (Kids refraction software vA), and phase B will involve the second version (Kids refraction software vB).
There are two phases in the investigation:
Phase A:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vA (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Phase B:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vB with additional attention and cooperation stages (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter | Active Comparator | Measurement of the non-cycloplegic refraction with Vision-R™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-R™ phoropter and comparison with non-cycloplegic refraction with Vision-R™ phoropter. |
|
| Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter | Active Comparator | Measurement of the non-cycloplegic refraction with Vision-S™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-S™ phoropter and comparison with non-cycloplegic refraction with Vision-S™ phoropter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-cycloplegic Objective refraction | Device | Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™) | The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia. | Day 1 |
| Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™) | Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees. | Day 1 |
| Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™) | Indicates the orientation of the Cylinder, measured in degrees (°) | Day 1 |
| Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™) | The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia. | Six months after Day 1 |
| Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™) | Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees. | Six months after Day 1 |
| Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Júlia Sousa | Contact | +351 21 409 60 79 | asousa@evidenze.com |
| Name | Affiliation | Role |
|---|---|---|
| José Manuel González- Meijome, PhD | Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão | Recruiting | Vila Nova de Famalicão | 4764-502 | Portugal |
There is no need to share individual anonymized data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-cycloplegic conventional subjective refraction | Device | Performed with Vision-R™ |
|
| Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) | Device | Performed with Vision-R™ |
|
| Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™) | Device | Performed with Vision-S™ |
|
| Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™) | Device | Performed with Vision-R™ |
|
| Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™) | Device | Performed with Vision-S™ |
|
| Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) | Device | Performed with Vision-R™ |
|
| Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™) | Device | Performed with Vision-S™ |
|
| Cycloplegic Objective refraction | Device | Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia |
|
| Non-cycloplegic Retinoscopy | Device | Performed with a retinoscope without cycloplegia |
|
| Cycloplegic retinoscopy | Device | Performed with a retinoscope with cycloplegia |
|
Indicates the orientation of the Cylinder, measured in degrees (°)
| Six months after Day 1 |
| Subjective Sphere (with conventional method with Vision-R™) | The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia. | Day 1 |
| Subjective Cylinder (with conventional method, with Vision-R™) | Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees. | Day 1 |
| Subjective Axis (with conventional method, with Vision-R™) | Indicates the orientation of the Cylinder, measured in degrees (°) | Day 1 |
| Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™) | Corrected visual acuity measure with Kids refraction software vA results | From enrollment (Day 1) to the end of the study at 7,5 months |
| Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™) | Corrected visual acuity measure with Kids refraction software vB results | From enrollment (Day 1) to the end of the study at 7,5 months |
| Visual acuity (with Conventionnal refraction method, with Vision-R™) | Corrected visual acuity measure with Conventionnal refraction method results | From enrollment (Day 1) to the end of the study at 7,5 months |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D006956 | Hyperopia |
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided