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NCT02806726
Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System
On this page:
Summary Quick facts Who can join Endpoints Results Adverse events Related trials Sources
Terminated
NA
Results posted
Last updated 4 February 2025
What this trial tests
NA trial testing iDesign 1.3-PRESBY treatment in Presbyopia in 42 participants. Terminated before completion.
Timeline
13 July 2016
Primary endpoint 9 November 2017
9 November 2017
Quick facts
Lead sponsor Abbott Medical Optics
Phase NA
Status Terminated
Study type INTERVENTIONAL
Allocation non randomized
Design parallel
Masking none
Primary purpose treatment
Enrollment 42
Start date 13 July 2016
Primary completion 9 November 2017
Estimated completion 9 November 2017
Drugs / interventions tested
iDesign 1.3-PRESBY treatment iDesign 1.3 treatment
Conditions studied
Sponsor
Abbott Medical Optics
Who can join
45 and older, any sex, with Presbyopia or Myopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm
Primary
· 6 months
Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Group Value 95% CI iDesign 1.3-Presby Treatment (Experimental) 0.03 -0.1 – 0.16 iDesign CustomVue Treatments (Control) 0.1 -0.02 – 0.22
Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm
Secondary
· 6 months
Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Group Value 95% CI iDesign 1.3-Presby Treatment (Experimental) 0.25 0.16 – 0.34 iDesign CustomVue Treatments (Control) 0.35 0.1 – 0.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Study Participants
Serious: 0/7 (0%)
Deaths: 0/7
Other adverse events (2 terms — click to expand) Reaction System All Study Participants Diffuse lamellar keratitis Eye disorders — Mild Headache General disorders —
Data from ClinicalTrials.gov NCT02806726 adverse events section .
Sponsor's own description
A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System. The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 1.3-PRESBY (presbyT-LASIK) treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT02806726 (US National Library of Medicine, public domain)
Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor : as reported to ClinicalTrials.gov by Abbott Medical Optics
Last refreshed : 4 February 2025
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