Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System

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: NCT02806726
Recruitment Status : Terminated (Decision to discontinue product development at this time)
First Posted : June 21, 2016
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Presbyopia
Myopia
Interventions Device: iDesign 1.3-PRESBY treatment
Device: iDesign 1.3 treatment
Enrollment 42
Recruitment Details  
Pre-assignment Details Per the protocol, the total number of participants enrolled is 42 (the number of participants who agreed to participate in the study and completed the informed consent process). The total number of participants Started is 7 (the number of participants who were assigned to each Arm/Group).
Arm/Group Title All Study Participants
Hide Arm/Group Description

Parts of a participant were allocated to different interventions:

  1. Left side iDesign 1.3-PRESBY, Right side iDesign 1.3
  2. Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
Period Title: Overall Study
Number of participants Number of units (Eyes Treated)
Started 7 [1] 14
Completed 6 [1] 12
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1            
[1]
Subjects were treated contralaterally
Arm/Group Title All Study Participants
Hide Arm/Group Description

Parts of a participant were allocated to different interventions:

  1. Left side iDesign 1.3-PRESBY, Right side iDesign 1.3
  2. Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
Overall Number of Baseline Participants 7
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
14
Hide Baseline Analysis Population Description
The safety population will be the primary analysis population for all endpoints and includes all eyes that receive study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
49.2  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
  85.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm
Hide Description Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.
Arm/Group Title iDesign 1.3-Presby Treatment (Experimental) iDesign CustomVue Treatments (Control)
Hide Arm/Group Description:
One of subject's eye (experimental) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign 1.3-PRESBY (presbyT-LASIK) treatments
One of subject's eye (control) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign CustomVue treatments
Overall Number of Participants Analyzed 6 6
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
6 6
Mean (95% Confidence Interval)
Unit of Measure: LogMAR
0.03
(-0.1 to 0.16)
0.1
(-0.02 to 0.22)
2.Secondary Outcome
Title Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm
Hide Description Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.
Arm/Group Title iDesign 1.3-Presby Treatment (Experimental) iDesign CustomVue Treatments (Control)
Hide Arm/Group Description:
One of subject's eye (experimental) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign 1.3-PRESBY (presbyT-LASIK) treatments
One of subject's eye (control) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign CustomVue treatments
Overall Number of Participants Analyzed 6 6
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
6 6
Mean (95% Confidence Interval)
Unit of Measure: LogMar
0.25
(0.16 to 0.34)
0.35
(0.1 to 0.6)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description

Parts of a participant were allocated to different interventions:

  1. Left side iDesign 1.3-PRESBY, Right side iDesign 1.3
  2. Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Participants
Affected / at Risk (%)
Total   2/7 (28.57%) 
Eye disorders   
Diffuse lamellar keratitis  [1]  1/7 (14.29%) 
General disorders   
Mild Headache   1/7 (14.29%) 
Indicates events were collected by systematic assessment
[1]
in iDesign 1.3-Presby Treated Eye
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priya Janakiraman
Organization: Johnson & Johnson Surgical Vision, Inc.
Phone: 1 714 2478628
EMail: djanaki1@its.jnj.com
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02806726    
Other Study ID Numbers: STAR-116-TOPS
First Submitted: June 8, 2016
First Posted: June 21, 2016
Results First Submitted: November 9, 2018
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019