Trial Outcomes & Findings for Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System (NCT NCT02806726)

Last Updated: 2025-02-04

Results Overview

Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

Recruitment status

TERMINATED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-04

Participant Flow

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).

Unit of analysis: Eyes Treated

Participant milestones

Participant milestones
Measure	All Study Participants 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 Study STARTED	7 14
Overall Study COMPLETED	6 12
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants 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 Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=14 Eyes 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
Age, Continuous	49.2 Years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.

Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

Outcome measures

Outcome measures
Measure	iDesign 1.3-Presby Treatment (Experimental) n=6 Eyes 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	iDesign CustomVue Treatments (Control) n=6 Eyes 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
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm	0.03 LogMAR Interval -0.1 to 0.16	0.1 LogMAR Interval -0.02 to 0.22

SECONDARY outcome

Timeframe: 6 months

Population: Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.

Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

Outcome measures

Outcome measures
Measure	iDesign 1.3-Presby Treatment (Experimental) n=6 Eyes 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	iDesign CustomVue Treatments (Control) n=6 Eyes 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
Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm	0.25 LogMar Interval 0.16 to 0.34	0.35 LogMar Interval 0.1 to 0.6

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Study Participants n=7 participants at risk 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
Eye disorders Diffuse lamellar keratitis	14.3% 1/7 • 6 months
General disorders Mild Headache	14.3% 1/7 • 6 months

Additional Information

Priya Janakiraman

Johnson & Johnson Surgical Vision, Inc.

Phone: 1 714 2478628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER