Presbyopia
Conditions
Keywords
presbyopia
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.
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.
Interventions
DEVICEAcuFocus Corneal Inlay ACI 7000 PDT
Inlay implanted in cornea for improvement of near vision
Sponsors
AcuFocus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (Increase) in Uncorrected Near Visual Acuity | Baseline and 2 years | The change in the number of lines of threshold visual acuity achieved postoperatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Age, Categorical Measure Type: Count of Participants | 271 |
| Total | 271 |
Baseline characteristics
| Characteristic | Age, Categorical |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 271 Participants |
| Region of Enrollment United States | 271 participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 271 |
| serious Total, serious adverse events | 10 / 271 |
Outcome results
Primary
Change (Increase) in Uncorrected Near Visual Acuity
The change in the number of lines of threshold visual acuity achieved postoperatively.
Time frame: Baseline and 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Prev. Implanted With ACI7000PDT | Change (Increase) in Uncorrected Near Visual Acuity | 3.1 lines of visual acuity improvement | Standard Deviation 1.7 |