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NCT04495829

Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

Completed Results posted Last updated 20 July 2023
What this trial tests

trial testing Phorcides Analytical Engine in Refractive Errors in 70 participants. Completed in 21 April 2021.

Timeline
24 July 2020
Primary endpoint
21 April 2021
21 April 2021

Quick facts

Lead sponsorAmerican Corneal Consultants
StatusCompleted
Study typeOBSERVATIONAL
Enrollment70
Start date24 July 2020
Primary completion21 April 2021
Estimated completion21 April 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

American Corneal Consultants

Who can join

20 and older, any sex, with Refractive Errors. 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.

Residual Refractive Cylinder Primary · 3 months postop

Residual refractive cylinder in diopters

GroupValue95% CI
Phorcides0.04± 0.09
Uncorrected Distance Visual Acuity Secondary · 3 months postop

Uncorrected visual acuity at distance (4-6m)

GroupValue95% CI
Phorcides-.11± 0.06
Residual Refractive Sphere Secondary · 3 months postop

Residual refractive spherical equivalent in diopters

GroupValue95% CI
Phorcides0.08± 0.20
Satisfaction and Vision Secondary · 3 months postop

A questionnaire related to visual quality and satisfaction after surgery

Double vision
GroupValue95% CI
Phorcides65
Phorcides0
Trouble driving at night
GroupValue95% CI
Phorcides65
Phorcides0
Trouble reading
GroupValue95% CI
Phorcides65
Phorcides0
Dryness
GroupValue95% CI
Phorcides63
Phorcides2
Foreign body sensation
GroupValue95% CI
Phorcides65
Phorcides0
Fluctuation in vision
GroupValue95% CI
Phorcides65
Phorcides0
Glare
GroupValue95% CI
Phorcides65
Phorcides0
Halos
GroupValue95% CI
Phorcides65
Phorcides0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phorcides
Serious: 0/70 (0%)
Deaths: 0/70
Other adverse events (1 terms — click to expand)

ReactionSystemPhorcides
Epithelial defectEye disorders

Data from ClinicalTrials.gov NCT04495829 adverse events section.

Sponsor's own description

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.

Publications & conference data

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

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Other recruiting trials for Refractive Errors

Currently open trials in the same condition.

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/NCT04495829.

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