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
Not provided
Not provided
Not provided
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized/Control | No Intervention | 7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21 | |
| Non-Randomized/Treatment | Experimental | Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PresVIEW Device Implantation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Near Visual Acuity | Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Near Visual Acuity | The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months | 12 Months |
| Presence of Significant Safety Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midland Eye | Birmingham | United Kingdom |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.
| 24 months |