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This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.
This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:
All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prev. impl. with ACI 7000 PDT | Experimental | AcuFocus Corneal Inlay ACI 7000 PDT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcuFocus Corneal Inlay ACI 7000 PDT | Device | Inlay implanted in cornea for improvement of near vision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change (Increase) in Uncorrected Near Visual Acuity | The change in the number of lines of threshold visual acuity achieved postoperatively. | Baseline and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Durrie, M.D. | Durrie Vision | Principal Investigator |
| Chad Betts, M.D., R.Ph | MacDonald Eye Associates | Principal Investigator |
| Vance Thompson, M.D. | Vance Thompson Vision | Principal Investigator |
| Jay Pepose, M.D. | Pepose Vision Institute | Principal Investigator |
| Kevin Waltz, M.D. | Eye Surgeons of Indiana | Principal Investigator |
| John Vukich, M.D. | Davis Duehr Dean | Principal Investigator |
| Peter Hersh, M.D. | Cornea and Laser Eye Institute | Principal Investigator |
| Thomas Tooma, M.D. | NVision | Principal Investigator |
| Colman Kraff, M.D. | Kraff Eye Institute | Principal Investigator |
| Robert Maloney, M.D. | Maloney Vision Institute |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDonald Eye Associates | Fayetteville | Arkansas | 72703 | United States | ||
| Maloney Vision |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Prev. Implanted With ACI7000PDT | Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Principal Investigator |
| Scott MacRae, M.D. | University of Rochester Eye Institute - Strong Vision | Principal Investigator |
| Gary Foster, M.D. | Eye Center of Northern Colorado | Principal Investigator |
| Phillip Hoopes, Sr., M.D. | Hoopes Vision | Principal Investigator |
| Los Angeles |
| California |
| 90024 |
| United States |
| NVision | Newport Beach | California | 92660 | United States |
| Eye Center NOCO | Fort Collins | Colorado | 80525 | United States |
| Kraff Eye Institute | Chicago | Illinois | 60602 | United States |
| Eye Surgeons of Indiana | Indianapolis | Indiana | 46256 | United States |
| Durrie Vision | Overland Park | Kansas | 66211 | United States |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| The Cornea & Laser Eye Institute, P.A | Teaneck | New Jersey | 07666 | United States |
| University of Rochester Eye Institute - Strong Vision | Rochester | New York | 14618 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57105 | United States |
| Hoopes Vision | Sandy City | Utah | 84070 | United States |
| Davis Duehr Dean | Madison | Wisconsin | 53715 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age, Categorical | Measure Type: Count of Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change (Increase) in Uncorrected Near Visual Acuity | The change in the number of lines of threshold visual acuity achieved postoperatively. | Posted | Mean | Standard Deviation | lines of visual acuity improvement | Baseline and 2 years |
|
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|
Two years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Prev. Implanted With ACI7000PDT | Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay | 10 | 271 | 23 | 271 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Pontine Hemorrage, Hypertensive Emergency |
|
| Carcinoma | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mucoepidermoid carcinoma of left mandibular gland |
|
| Motorcycle Accident | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Broken collar bone and six broken ribs |
|
| Breast Cancer | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Joint Replacement Surgery | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Two knee, one hip |
|
| Benign Brain Tumor | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Parathyroid gland |
|
| Cyst Removal | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Synovial cyst |
|
| Appendicitis | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Meibomian gland dysfunction |
|
| Secondary Surgical Intervention | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Treatment of hyperopic shift - inlay in place (3) Inlay removal |
|
| Superficial Punctate Keratitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctival cyst | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | OS |
|
| Retinal pigment epithelium granularity | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Retinal changes |
|
| Corneal abrasion | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | OS poked by tree branch - resolved in four days |
|
| Vision | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Decrease in BCDVA two lines at Month 3 or later |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugenia Thomas, Director Clinical Trials | AcuFocus, Inc. | 9495859511 | nthomas@acufocus.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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