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NCT02806726

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

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 sponsorAbbott Medical Optics
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment42
Start date13 July 2016
Primary completion9 November 2017
Estimated completion9 November 2017

Drugs / interventions tested

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).

GroupValue95% 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).

GroupValue95% CI
iDesign 1.3-Presby Treatment (Experimental)0.250.16 – 0.34
iDesign CustomVue Treatments (Control)0.350.1 – 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)

ReactionSystemAll Study Participants
Diffuse lamellar keratitisEye disorders
Mild HeadacheGeneral 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.

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Other recruiting trials for Presbyopia

Currently open trials in the same condition.

Other Abbott Medical Optics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02806726.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing