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CompletedNCT02775097Updated Sep 27, 2016

Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

An observational study in Cornea, sponsored by Optovue. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Optovue · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
89
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.

02

Conditions studied

  • Cornea
03

In context

Lead sponsor

Optovue is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Seeing eye doctor for routine or follow-up care

Inclusion criteria

Normal

  • Able and willing to provide consent.
  • Able and willing to complete required exams.

Corneal conditions

  • Able and willing to provide consent.
  • Able and willing to complete required exams.
  • History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion criteria

Exclusion Criteria:

Normal

  • History of refractive surgery, contact lens, dry eye or pathology.
  • Blepharitis or meibomitis
  • Unable to complete required exams.

Corneal conditions

  • Unable to complete required exams.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
89 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal

    Not having any history of refractive surgery, contact lens, dry eye or pathology

    Device: OCT

  • Corneal condition

    History of refractive surgery, contact lens, dry eye or keratoconus.

    Device: OCT

Interventions

  • DeviceOCT

    OCT for all Arms

06

What researchers measure

Primary outcomes

  1. Epithelial thickness

    Time frame: Day 1

Secondary outcomes

  1. Corneal thickness

    Time frame: Day 1

Other outcomes

  1. Stromal thickness

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02775097
Lead sponsor
Optovue
Responsible party
Sponsor
First posted
May 17, 2016
Start date
Apr 2016
Primary completion
Jun 2016
Completion
Jul 2016
Last update
Sep 27, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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