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NCT03063164

A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Completed NA Results posted Last updated 14 December 2021
What this trial tests

NA trial testing Intralase IFS150 in Myopia in 7 participants. Completed in 13 November 2018.

Timeline
14 February 2017
Primary endpoint
13 November 2018
13 November 2018

Quick facts

Lead sponsorEdward E. Manche
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment7
Start date14 February 2017
Primary completion13 November 2018
Estimated completion13 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Edward E. Manche

Who can join

Adults 21 to 60, any sex, with Myopia or Astigmatism. 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.

ETDRS Uncorrected Visual Acuity Primary · At post-operative month 12

Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

GroupValue95% CI
Intralase IFS Eye5
Visumax Eye5
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation Secondary · At postoperative month twelve

Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.

Score of greater than or equal to 5
GroupValue95% CI
Intralase IFS Eye7
Visumax Eye7
Score of less than 5
GroupValue95% CI
Intralase IFS Eye0
Visumax Eye0
Best Spectacle Corrected Visual Acuity Secondary · Postoperative month 12

Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

GroupValue95% CI
Intralase IFS Eye0
Visumax Eye0
Questionnaire Measuring Patient Preference for Laser Device Secondary · Intraoperative (Approximately 1 minute after completion of surgery)

Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.

Preferred Visumax
GroupValue95% CI
All Participants3
Preferred Intralase IFS
GroupValue95% CI
All Participants2
No preference
GroupValue95% CI
All Participants2

Sponsor's own description

Comparing LASIK outcomes using two femtosecond lasers

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Myopia

Currently open trials in the same condition.

Other Edward E. Manche 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/NCT03063164.

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