Evaluation of OCT Measurements

Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma Clinical Trial

Official title:

Evaluation of the Precision and Accuracy of OCT Measurements in Retinal and Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806402
• Other study ID #: 20130104
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: January 20, 2014
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Optovue
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.

Description:

The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology. There will be a series of measurements acquired from one eye on at least 2 different OCT devices. All testing will be completed in one visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion Criterea:

• At least 18 years of age

• Able and willing to provide consent

• Willing to complete the required examinations and visits

• Best corrected visual acuity equal or better than 20/100

• Retina subject must have clinical diagnosis of retinal pathology

• Glaucoma subjects must have clinical diagnosis of glaucoma

Exclusion Criteria:

• Unable to complete the required examinations and visits

• Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment

• Confounding pathology requiring surgical treatment or medical intervention

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma
• Glaucoma

Locations

Country	Name	City	State
United States	Pacific Eye Specialists	Daly City	California
United States	North Bay Eye Associates	Petaluma	California
United States	West Coast Retinal Medical Group	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Optovue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retina thickness		Day 1	No