Trial Outcomes & Findings for Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes (NCT NCT00850031)
NCT ID: NCT00850031
Last Updated: 2018-02-28
Results Overview
Percent of subjects who achieved UCNVA of 20/40 or better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
12 months
Results posted on
2018-02-28
Participant Flow
119 participants were consented for the study (enrolled), and 118 subsequently were implanted with the device (started) for the study.
Participant milestones
| Measure |
AcuFocus Corneal Inlay
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Overall Study
STARTED
|
118
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes
Baseline characteristics by cohort
| Measure |
AcuFocus Corneal Inlay
n=118 Participants
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPercent of subjects who achieved UCNVA of 20/40 or better.
Outcome measures
| Measure |
AcuFocus Corneal Inlay
n=118 Participants
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Improvement in Uncorrected Near Visual Acuity
|
78.2 percentage of participants
|
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=118 Participants
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Improvement of Near Uncorrected Visual Acuity
|
4.7 units on a scale
Standard Deviation 1.7
|
Adverse Events
AcuFocus Corneal Inlay
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AcuFocus Corneal Inlay
n=118 participants at risk
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Surgical and medical procedures
Hospitalization secondary to prostatectomy
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Injury, poisoning and procedural complications
Hospitalization due to bike accident
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Stromal thinning secondary to abnormal healing response to corneal trauma
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Surgical and medical procedures
Hip replacement surgery
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
Other adverse events
| Measure |
AcuFocus Corneal Inlay
n=118 participants at risk
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
|
|---|---|
|
Infections and infestations
Blepharitis
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Superficial punctate keratitis
|
1.7%
2/118 • Number of events 2 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Surgical and medical procedures
Flap complication
|
1.7%
2/118 • Number of events 2 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Vision
|
7.6%
9/118 • Number of events 9 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Cornea
|
6.8%
8/118 • Number of events 8 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Surgical and medical procedures
Secondary Surgical Intervention
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Intraocular Pressure
|
4.2%
5/118 • Number of events 5 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Conjunctivitis
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Hordeolum
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Limbal foreign body
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Corneal abrasion/erosion
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Foreign bodies over inlay with anterior corneal surface defect
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Lens
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Meibomian Gland Dysfunction
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Partial sidecut at inner edge of mask
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Admission to hospital for severe headache
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Hypercholesterolemia
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Increased blood sugar
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Hypertension
|
1.7%
2/118 • Number of events 2 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Scleroderma
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Chest Infection
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Surgical and medical procedures
Knee injury & surgery
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Non-insulin-dependent diabetes mellitus
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
General disorders
Benign Prostate Hyperplasia
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Conjunctival Cyst
|
0.85%
1/118 • Number of events 1 • 3 months, 6 months, 1 year, 2 years,3 years
|
|
Eye disorders
Upper eyelid chalazion
|
0.85%
1/118 • Number of events 1 • 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
Restriction type: OTHER