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

NCT ID: NCT02775097

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cornea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal

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

OCT

Intervention Type DEVICE

OCT for all Arms

Corneal condition

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

OCT

Intervention Type DEVICE

OCT for all Arms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCT

OCT for all Arms

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Optovue

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200-50996

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of OCT Measurements
NCT01806402 COMPLETED
Retinal Investigation Using Optos OCT Device
NCT06846151 NOT_YET_RECRUITING NA
Nidek RS3000 Comparative Study
NCT01384487 COMPLETED