Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Outcome Measures
Primary Outcome Measures
- Rates of secondary surgical interventions (SSIs) [3 years post IC-8 Apthera IOL implantation]
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
- Rates of other serious adverse events [3 years post IC-8 Apthera IOL implantation]
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
- Rates of ocular adverse events [3 years post IC-8 Apthera IOL implantation]
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
- Rates of subjective visual disturbances [3 years post IC-8 Apthera IOL implantation]
Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)
Other Outcome Measures
- Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes [3 years post IC-8 Apthera IOL implantation]
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
- Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes [3 years post IC-8 Apthera IOL implantation]
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
- Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) [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) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes
- Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) [3 years post IC-8 Apthera IOL implantation]
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
- 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 [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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
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Able to comprehend and have signed a statement of informed consent
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Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
Exclusion Criteria:
- There are no exclusion criteria for this study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center | Tucson | Arizona | United States | 85704 |
2 | Empire Eye & Laser Center | Bakersfield | California | United States | 93309 |
3 | Harvard Eye Associates | Laguna Hills | California | United States | 92653 |
4 | Altos Eye Physicians | Los Altos | California | United States | 94024 |
5 | Advanced Vision Care | Los Angeles | California | United States | 90067 |
6 | Eye Center of Northern Colorado | Fort Collins | Colorado | United States | 80525 |
7 | Eye Center of North Florida | Panama City | Florida | United States | 32405 |
8 | Chu Vision Institute | Bloomington | Minnesota | United States | 55420 |
9 | Pepose Vision Institute | Saint Louis | Missouri | United States | 63128 |
10 | Kugler Vision | Omaha | Nebraska | United States | 68118 |
11 | Alterman, Modi & Wolter | Poughkeepsie | New York | United States | 12603 |
12 | Physicians Protocol | Greensboro | North Carolina | United States | 27408 |
13 | Cleveland Eye Clinic | Brecksville | Ohio | United States | 44141 |
14 | Philadelphia Eye Associates | Philadelphia | Pennsylvania | United States | 19148 |
15 | Bucci Laser Vision | Wilkes-Barre | Pennsylvania | United States | 18702 |
16 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
17 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
18 | Parkhurst NuVision | San Antonio | Texas | United States | 78229 |
19 | Hoopes Vision | Draper | Utah | United States | 84021 |
20 | Utah Eye Centers | Ogden | Utah | United States | 84403 |
21 | Virginia Eye Consultants | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- AcuFocus, Inc.
Investigators
- Study Director: Magda Michna, Ph.D., AcuFocus, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAIL-101-PAS