Trial Outcomes & Findings for A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A (NCT NCT01895088)

Last Updated: 2017-08-01

Results Overview

The change in the number of lines of threshold visual acuity achieved postoperatively.

Recruitment status

COMPLETED

Study phase

Target enrollment

271 participants

Primary outcome timeframe

Baseline and 2 years

Results posted on

2017-08-01

Participant milestones
Measure	Patients Prev. Implanted With ACI7000PDT Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay
Overall Study STARTED	271
Overall Study COMPLETED	253
Overall Study NOT COMPLETED	18

Withdrawal data not reported

A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A

Baseline characteristics by cohort
Measure	Age, Categorical n=271 Participants Measure Type: Count of Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	271 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants
Region of Enrollment United States	271 participants n=5 Participants

Timeframe: Baseline and 2 years

The change in the number of lines of threshold visual acuity achieved postoperatively.

Outcome measures
Measure	Patients Prev. Implanted With ACI7000PDT n=271 Participants Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: Inlay implanted in cornea for improvement of near vision
Change (Increase) in Uncorrected Near Visual Acuity	3.1 lines of visual acuity improvement Standard Deviation 1.7

Serious events: 10 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events
Measure	Patients Prev. Implanted With ACI7000PDT n=271 participants at risk Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay
Nervous system disorders Cerebrovascular Accident	0.37% 1/271 • Number of events 1 • Two years
General disorders Carcinoma	0.37% 1/271 • Number of events 1 • Two years
Musculoskeletal and connective tissue disorders Motorcycle Accident	0.37% 1/271 • Number of events 1 • Two years
Reproductive system and breast disorders Breast Cancer	0.37% 1/271 • Number of events 1 • Two years
Surgical and medical procedures Joint Replacement Surgery	1.1% 3/271 • Number of events 3 • Two years
Surgical and medical procedures Benign Brain Tumor	0.37% 1/271 • Number of events 1 • Two years
Surgical and medical procedures Cyst Removal	0.37% 1/271 • Number of events 1 • Two years
Surgical and medical procedures Appendicitis	0.37% 1/271 • Number of events 1 • Two years

Other adverse events
Measure	Patients Prev. Implanted With ACI7000PDT n=271 participants at risk Prev. implanted in ACU-P08-020/020A study AcuFocus Corneal Inlay ACI 7000 PDT: corneal inlay
Eye disorders Blepharitis	0.37% 1/271 • Number of events 1 • Two years
Eye disorders Secondary Surgical Intervention	1.5% 4/271 • Number of events 4 • Two years
Eye disorders Superficial Punctate Keratitis	0.37% 1/271 • Number of events 1 • Two years
Eye disorders Conjunctival cyst	0.37% 1/271 • Number of events 1 • Two years
Eye disorders Retinal pigment epithelium granularity	0.37% 1/271 • Number of events 1 • Two years
Eye disorders Corneal abrasion	0.37% 1/271 • Number of events 1 • Two years
Eye disorders Vision	5.2% 14/271 • Number of events 14 • Two years

AcuFocus, Inc.

Phone: 9495859511