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Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01352442
Recruitment Status : Completed
First Posted : May 11, 2011
Results First Posted : September 18, 2015
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
AcuFocus, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Presbyopia
Intervention Device: AcuFocus Corneal Inlay ACI 7000PDT
Enrollment 151
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AcuFocus Corneal Inlay
Hide Arm/Group Description

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

Period Title: Overall Study
Started 151
Completed 139
Not Completed 12
Arm/Group Title AcuFocus Corneal Inlay
Hide Arm/Group Description

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 Number of Baseline Participants 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
<=18 years
0
   0.0%
Between 18 and 65 years
151
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants
51  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
71
  47.0%
Male
80
  53.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants
Austria 9
Japan 9
Singapore 8
Philippines 26
Turkey 36
New Zealand 16
Australia 26
Spain 3
Netherlands 6
France 12
1.Primary Outcome
Title Uncorrected Near Visual Acuity 20/32 or Better
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AcuFocus Corneal Inlay
Hide Arm/Group Description:

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 Number of Participants Analyzed 139
Measure Type: Number
Unit of Measure: percentage of subjects
73.8
2.Secondary Outcome
Title Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
Hide Description Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AcuFocus Corneal Inlay
Hide Arm/Group Description:

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 Number of Participants Analyzed 139
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
5.4
(2.3 to 8.5)
Time Frame 3 months, 6 months, 1 year, 2 years, 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AcuFocus Corneal Inlay
Hide Arm/Group Description

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

All-Cause Mortality
AcuFocus Corneal Inlay
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
AcuFocus Corneal Inlay
Affected / at Risk (%)
Total   7/151 (4.64%) 
Cardiac disorders   
Hospitalization for Atrial Fibrilation * 1 [1]  1/151 (0.66%) 
Investigations   
Hospitalization for investigation of bladder. Suspected cancer. Planned event. * 1 [1]  1/151 (0.66%) 
Musculoskeletal and connective tissue disorders   
Complete division of left Achilles tendon * 1 [1]  1/151 (0.66%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain and Lung cancer requiring extended hospitalization * 1 [1]  1/151 (0.66%) 
Hospitalization for laser treatment of bladder cancer. Planned event * 1 [1]  1/151 (0.66%) 
Pancreatic Cancer * 1 [1]  1/151 (0.66%) 
Skin and subcutaneous tissue disorders   
Hospitalisation for Systemic Cellulitis * 1 [1]  1/151 (0.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
All Serious Adverse Events reported in this study were not related to the eye.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AcuFocus Corneal Inlay
Affected / at Risk (%)
Total   34/151 (22.52%) 
Cardiac disorders   
Atrial Fibrilation * 1  1/151 (0.66%) 
Eye disorders   
Corneal Edema with grade of greater than or equal to 2+ (at one month or later) * 1  2/151 (1.32%) 
Epithelial Ingrowth * 1  2/151 (1.32%) 
Intraocular pressure * 1 [1]  7/151 (4.64%) 
Allergic reaction to study medication (lids) * 1  1/151 (0.66%) 
Blepharitis * 1  1/151 (0.66%) 
AcuFocus Corneal Inlay re-centration or replacement * 1  9/151 (5.96%) 
Dry eye * 1  1/151 (0.66%) 
Decrease in Best Corrected Distance Visual Acuity greater than 2 lines at Month 3 or later * 1  6/151 (3.97%) 
Adenoviral Conjunctivitis * 1  1/151 (0.66%) 
Flap complication * 1  1/151 (0.66%) 
Injury, poisoning and procedural complications   
Bone fracture * 1  2/151 (1.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Intraocular pressure increase greater than 10 mmHg above baseline or Intraocular pressure greater than 25 mmHg (with clinical findings)
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
Layout table for Results Point of Contact information
Name/Title: Eugenia Thomas, OD
Organization: AcuFocus, Inc.
Phone: 949-585-9511
EMail: ethomas@acufocus.com
Layout table for additonal information
Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT01352442    
Other Study ID Numbers: ACU-P10-020B
First Submitted: May 10, 2011
First Posted: May 11, 2011
Results First Submitted: August 19, 2015
Results First Posted: September 18, 2015
Last Update Posted: March 28, 2017