Recruiting

Ultrawide Field Cameras vs. Gold Standard

Sponsor:

University of Wisconsin, Madison

Code:

NCT06380075

Conditions

Retinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spectralis FAF imaging

Optos imaging

Clarus imaging

Study Details

Brief summary:

The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).

Participants will:

  • undergo pupillary dilation
  • have photographs taken of the inside of the eyes using three different cameras

Conditions

Retinal Disease

Study ID

NCT06380075

Start date

Aug 29, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
  • Participants that are willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

  • Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
  • Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
  • Patients with advanced IRDs who are unable to fixate for imaging
  • Patients unable to tolerate ocular imaging
  • Patients who do not wish to participate

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fundus autofluorescence (FAF) imaging

Interventions

Spectralis FAF imaging

Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina.

Optos imaging

Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images.

Clarus imaging

Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm

Primary outcome measure

  • Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging [ Time Frame: Up to 2 hours ]
  • Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging [ Time Frame: Up to 2 hours ]
  • Compare FAF retinal patterns by Clarus and Optos FAF imaging [ Time Frame: Up to 2 hours ]
  • Compare Spectralis FAF imaging to Spectralis OCT imaging [ Time Frame: Up to 2 hours ]

Central Contacts and Locations

Central contacts

Angie Adler

608-265-7557amadler1@wisc.edu

Locations

Department of Ophthalmology and Visual Sciences

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Amy Remm

608-262-3377amy.remm@wisc.edu

Principal Investigator:

Kimberly Stepien, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-04-24.