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Testing a new eye imaging device in people with optic nerve and retina damage

Tests an eye imaging device in adults with retina or optic nerve conditions.

Key facts

Who runs it
Randy Kardon
Where
Iowa City, United StatesSee the site
Trial code
Registry title
New Non-invasive Modalities for Assessing Retinal Structure and Function
Status
Recruiting
People taking part
500 people, planned
Started
6 May 2019
Expected to end
1 Mar 2028
Type of study
Interventional
Treatments tested
  • LSFG-NAVI
Record updated
8 September 2026

Who can take part

Age
18 years to 99 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 16 criteriaShow less

Other criteria

  • Controls:
  • Inclusion:
  • Normal eye exam in last 2 years
  • Exclusion:
  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal
  • Subjects with Inner Retina Defect:
  • Inclusion:
  • Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies
  • Exclusion:
  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay
  • Subjects with Outer Retinal Defect:
  • Inclusion:
  • AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
  • Exclusion:
  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay
  • The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Where in United States

  • University of Iowa Department of OphthalmologyIowa City, United StatesContact: Denise L Rettig, MHA. MBATaking people

About the trial

What the trial wants to find out

This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.

The group in the trial

  • Laser Speckle Blood Flow GroupTreatment being tested

    Treatment: LSFG-NAVI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
Plain-language title
Testing a new eye imaging device in people with optic nerve and retina damageGenerated from the registry record. The registry title is the official one.
Fit questions
Built from NCT03475173, who can take part
Record updated
8 September 2026