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The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC-8 Apthera intraocular lens (IOL) Group | Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of secondary surgical interventions (SSIs) | Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit | 3 years post IC-8 Apthera IOL implantation |
| Rates of other serious adverse events | Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit | 3 years post IC-8 Apthera IOL implantation |
| Rates of ocular adverse events | Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit | 3 years post IC-8 Apthera IOL implantation |
| Rates of subjective visual disturbances | Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s) | 3 years post IC-8 Apthera IOL implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes | Monocular best-corrected distance visual acuity will be assessed at the Study visit in the IC-8 Apthera intraocular lens (IOL) eyes and in the fellow eyes | 3 years post IC-8 Apthera IOL implantation |
| Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes |
Inclusion Criteria:
Exclusion Criteria:
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Potential study subjects will be recruited from patients previously enrolled in the IC-8 Apthera intraocular lens (IOL) Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center | Tucson | Arizona | 85704 | United States | ||
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Rate of intraocular lens (IOL) removals (based on eyes with events) will be assessed at the Study visit in the IC-8 Apthera IOL eyes and in the fellow eyes |
| 3 years post IC-8 Apthera IOL implantation |
| Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) | Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes | 3 years post IC-8 Apthera IOL implantation |
| Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) | Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes | 3 years post IC-8 Apthera IOL implantation |
| Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes in postoperative Manifest Refraction Spherical Equivalent (MRSE) groups | Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes may be evaluated in postoperative Manifest Refraction Spherical Equivalent groups: -1.01 D to more myopic, -1.00 D to -0.50 D, -0.49 D to -0.25 D, -0.24 D to 0.00 D, +0.01 D to +0.25 D, +0.26 D to more hyperopic. | 3 years post IC-8 Apthera IOL implantation |
| Empire Eye & Laser Center |
| Bakersfield |
| California |
| 93309 |
| United States |
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States |
| Altos Eye Physicians | Los Altos | California | 94024 | United States |
| Advanced Vision Care | Los Angeles | California | 90067 | United States |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80525 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Pepose Vision Institute | St Louis | Missouri | 63128 | United States |
| Kugler Vision | Omaha | Nebraska | 68118 | United States |
| Alterman, Modi & Wolter | Poughkeepsie | New York | 12603 | United States |
| Physicians Protocol | Greensboro | North Carolina | 27408 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | United States |
| Bucci Laser Vision | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Hoopes Vision | Draper | Utah | 84021 | United States |
| Utah Eye Centers | Ogden | Utah | 84403 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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