The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

Completed

• Conditions: Retinal Layer Separation
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT03903588
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess two grids.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-22
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	Optical Coherence Tomography	Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
Retinal Disease	Optical Coherence Tomography	Eyes that have been diagnoses with a Retinal Disease
Glaucoma	Optical Coherence Tomography	Eyes that have been diagnoses with Glaucoma

Primary Outcome Measures

Name	Time	Method
Retinal Layer Thickness	5 months	Measurement of the thickness of Retinal layers thickness to assess 2 grids

Trial Locations

Locations (1)

State University of New York Optometry School; 🇺🇸 New York, New York, United States