Trial Outcomes & Findings for Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes (NCT NCT01352442)
NCT ID: NCT01352442
Last Updated: 2017-03-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
12 months
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
AcuFocus Corneal Inlay
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
Baseline characteristics by cohort
| Measure |
AcuFocus Corneal Inlay
n=151 Participants
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
36 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
AcuFocus Corneal Inlay
n=139 Participants
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Uncorrected Near Visual Acuity 20/32 or Better
|
73.8 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthsMean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).
Outcome measures
| Measure |
AcuFocus Corneal Inlay
n=139 Participants
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
|
5.4 Scores on a scale
Interval 2.3 to 8.5
|
Adverse Events
AcuFocus Corneal Inlay
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AcuFocus Corneal Inlay
n=151 participants at risk
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Complete division of left Achilles tendon
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain and Lung cancer requiring extended hospitalization
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Investigations
Hospitalization for investigation of bladder. Suspected cancer. Planned event.
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for laser treatment of bladder cancer. Planned event
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Skin and subcutaneous tissue disorders
Hospitalisation for Systemic Cellulitis
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Cardiac disorders
Hospitalization for Atrial Fibrilation
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
Other adverse events
| Measure |
AcuFocus Corneal Inlay
n=151 participants at risk
The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Eye disorders
Corneal Edema with grade of greater than or equal to 2+ (at one month or later)
|
1.3%
2/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Epithelial Ingrowth
|
1.3%
2/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Intraocular pressure
|
4.6%
7/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Allergic reaction to study medication (lids)
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Blepharitis
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
AcuFocus Corneal Inlay re-centration or replacement
|
6.0%
9/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Dry eye
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Decrease in Best Corrected Distance Visual Acuity greater than 2 lines at Month 3 or later
|
4.0%
6/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Injury, poisoning and procedural complications
Bone fracture
|
1.3%
2/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Adenoviral Conjunctivitis
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Cardiac disorders
Atrial Fibrilation
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
|
Eye disorders
Flap complication
|
0.66%
1/151 • 3 months, 6 months, 1 year, 2 years, 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place