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| Name | Class |
|---|---|
| TigerMed | INDUSTRY |
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The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
This clinical study has two phases: prospective and retrospective.
Prospective Phase - evaluates the post-market long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up.
Retrospective phase - evaluates the post-market long-term safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paragon CRT®100 Contact Lens | Experimental | participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paragon CRT®100 Contact Lens | Device | Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes. |
| Measure | Description | Time Frame |
|---|---|---|
| product effectiveness | Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated*100% | 1 month |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At baseline |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | 1 day |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 1 week |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 2 weeks |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 1 month |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Age under 8 years old
Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00D or more than 46.00D
Best corrected visual acuity less than 1.0D
Pregnant, lactating or near-pregnancy
The eye has the following conditions:
Manifested strabismus
Abnormal intra-ocular pressure
Suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.)
Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
Examination result indicate any contraindication or not suitable for OrthoK lens wear
Participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening
Only eye fulfills inclusion criteria
History of any ocular operations
Unable to follow investigator's instruction
Any other condition not suitable for the study per investigator's judgement
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD, MSc | Contact | 9256402964 | jvega2@coopervision.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Jun, MD | The Affiliated Eye Hospital of Wenzhou Medical University | Principal Investigator |
| Qu Xiao Mei, MD | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changsha Aier Eye Hospital | Recruiting | Shanghai | China |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2022 | May 5, 2022 | 1 | ||
| Aug 25, 2022 |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Prospective, open label, 12 month follow up study
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| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 6 months |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 9 months |
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 12 months/final visit |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At Baseline |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 day |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 week |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 2 weeks |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 month |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 3 months |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 6 months |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 9 months |
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 12 months/final visit |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At Baseline |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 1 day |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 1 week |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 2 weeks |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 1 month |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 3 months |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 6 months |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 9 months |
| The relevant important parameters of corneal topography of subject | The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism. | At 12 months/final visit |
| Yang Zhi Kuan, MD |
| Changsha Aier Eye Hospital |
| Principal Investigator |
| Li Li Hua, MD | Tianjin Eye Hospital | Principal Investigator |
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | China |
|
| Tianjin Eye Hospital | Recruiting | Tianjin | China |
|
| The Affiliated Eye Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
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| Sep 23, 2022 |
| 2 |