SDOCT-GMPE Software

Duke University

Status: Completed

Conditions: Glaucoma

Treatments: Device: SDOCT-GMPE software

Study type: Interventional

Funder types: Other

Identifiers

NCT02235454

Pro00056471

Details and patient eligibility

About

The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for spectral domain optical coherence tomography (SDOCT) and if this software is superior to the conventional one that is currently used for SDOCT.

Full description

The new GMPE software can now identify the ocular structures without input from the operator thus reducing operator induced errors. It also measures the thickness of the entire optic nerve head so as to allow for another anatomic area of the eye to be measured for assessment of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data in three concentric circles instead of just one in order to account for different sizes of optic nerves.

Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye Center and its associated satellite clinics. Following informed consent, subjects undergo additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated satellite clinics. The imaging results may be used in clinical care for the subjects.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• capable and willing to provide consent
• history of clinically-diagnosed glaucoma
• at least 18 years of age

Exclusion criteria

• unable or unwilling to give consent
• under 18 years of age

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Glaucoma arm

Other group

Description:

Consecutive patients with glaucoma will undergo non-invasive OCT imaging

Treatment:

Device: SDOCT-GMPE software