A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
-
Specular microscopy
-
Slit lamp and fundus examination (ocular health)
-
Corrected and uncorrected visual acuity
-
Manifest mid-point refraction
-
Corneal topography
-
Dry eye assessment
-
Mesopic and Photopic contrast sensitivity
-
Adverse events and complications
All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients prev. impl. with ACI 7000 PDT AcuFocus Corneal Inlay ACI 7000 PDT |
Device: AcuFocus Corneal Inlay ACI 7000 PDT
Inlay implanted in cornea for improvement of near vision
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change (Increase) in Uncorrected Near Visual Acuity [Baseline and 2 years]
The change in the number of lines of threshold visual acuity achieved postoperatively.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must have completed participation in the ACU-P08-020/020A clinical trial.
-
Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
- Patients who did not complete ACU-P08-020/020A.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McDonald Eye Associates | Fayetteville | Arkansas | United States | 72703 |
| 2 | Maloney Vision | Los Angeles | California | United States | 90024 |
| 3 | NVision | Newport Beach | California | United States | 92660 |
| 4 | Eye Center NOCO | Fort Collins | Colorado | United States | 80525 |
| 5 | Kraff Eye Institute | Chicago | Illinois | United States | 60602 |
| 6 | Eye Surgeons of Indiana | Indianapolis | Indiana | United States | 46256 |
| 7 | Durrie Vision | Overland Park | Kansas | United States | 66211 |
| 8 | Pepose Vision Institute | Chesterfield | Missouri | United States | 63017 |
| 9 | The Cornea & Laser Eye Institute, P.A | Teaneck | New Jersey | United States | 07666 |
| 10 | University of Rochester Eye Institute - Strong Vision | Rochester | New York | United States | 14618 |
| 11 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57105 |
| 12 | Hoopes Vision | Sandy City | Utah | United States | 84070 |
| 13 | Davis Duehr Dean | Madison | Wisconsin | United States | 53715 |
Sponsors and Collaborators
- AcuFocus, Inc.
Investigators
- Principal Investigator: 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
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ACU-P12-020C
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients Prev. Implanted With ACI7000PDT |
|---|---|
| Arm/Group Description | Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay |
| Period Title: Overall Study | |
| STARTED | 271 |
| COMPLETED | 253 |
| NOT COMPLETED | 18 |
Baseline Characteristics
| Arm/Group Title | Age, Categorical |
|---|---|
| Arm/Group Description | Measure Type: Count of Participants |
| Overall Participants | 271 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
271
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
146
53.9%
|
| Male |
125
46.1%
|
| Region of Enrollment (participants) [Number] | |
| United States |
271
100%
|
Outcome Measures
| Title | Change (Increase) in Uncorrected Near Visual Acuity |
|---|---|
| Description | The change in the number of lines of threshold visual acuity achieved postoperatively. |
| Time Frame | Baseline and 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients Prev. Implanted With ACI7000PDT |
|---|---|
| Arm/Group Description | Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: Inlay implanted in cornea for improvement of near vision |
| Measure Participants | 271 |
| Mean (Standard Deviation) [lines of visual acuity improvement] |
3.1
(1.7)
|
Adverse Events
| Time Frame | Two years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Patients Prev. Implanted With ACI7000PDT | |
| Arm/Group Description | Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay | |
All Cause Mortality |
||
| Patients Prev. Implanted With ACI7000PDT | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Patients Prev. Implanted With ACI7000PDT | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/271 (3.7%) | |
| General disorders | ||
| Carcinoma | 1/271 (0.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Motorcycle Accident | 1/271 (0.4%) | 1 |
| Nervous system disorders | ||
| Cerebrovascular Accident | 1/271 (0.4%) | 1 |
| Reproductive system and breast disorders | ||
| Breast Cancer | 1/271 (0.4%) | 1 |
| Surgical and medical procedures | ||
| Joint Replacement Surgery | 3/271 (1.1%) | 3 |
| Benign Brain Tumor | 1/271 (0.4%) | 1 |
| Cyst Removal | 1/271 (0.4%) | 1 |
| Appendicitis | 1/271 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Patients Prev. Implanted With ACI7000PDT | ||
| Affected / at Risk (%) | # Events | |
| Total | 23/271 (8.5%) | |
| Eye disorders | ||
| Blepharitis | 1/271 (0.4%) | 1 |
| Secondary Surgical Intervention | 4/271 (1.5%) | 4 |
| Superficial Punctate Keratitis | 1/271 (0.4%) | 1 |
| Conjunctival cyst | 1/271 (0.4%) | 1 |
| Retinal pigment epithelium granularity | 1/271 (0.4%) | 1 |
| Corneal abrasion | 1/271 (0.4%) | 1 |
| Vision | 14/271 (5.2%) | 14 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eugenia Thomas, Director Clinical Trials |
|---|---|
| Organization | AcuFocus, Inc. |
| Phone | 9495859511 |
| nthomas@acufocus.com |
- ACU-P12-020C