NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

Completed

Conditions studied: AMD - Age-Related Macular Degeneration, Diabetic Macular Edema

In brief

Primary objective: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients. Secondary objectives: 1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients. 2. To evaluate patient experience when self-operating the Notal-OCT V2.5.

Key facts

Study ID

NCT03969303

Run by

Notal Vision Ltd.

People needed

287

Starts

2018-10-20

Expected to finish

2019-10-04

Last updated by the study team

2020-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and willingness to give informed consent (IC)
• 18 years of age or older
• Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
• Ability to undergo OCT (optical coherence tomography) testing
• Visual acuity of 20/400 Snellen (6/120) or better in the study eye

You may not qualify if…

• Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.

Where it is running

• Elman Retina Group, PA — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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