Comparing OCTA images from the Intalight VG200D Dream and Optos California FA/ICGA in retinal disease
Image Evaluation of Intalight Dream OCTA Scans With Optos FA & ICGA Images
This test compares OCTA scans from the Intalight VG200D Dream device with FA and ICGA images from the Optos California to see if they show similar retinal blood vessel detail for adults with retinal disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Intalight, Inc Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07568704 on ClinicalTrials.gov |
What this trial studies
This prospective, single-site comparison obtains OCTA scans from the investigational VG200D (Dream) device and FA/ICGA images from the Optos California in adults with retinal pathology. At least one acceptable scan will be captured per device for each enrolled eye and images will be reviewed by three expert graders. Graders will rate images for technical quality and clinical utility in visualizing the retinal vasculature, and results will be compared across devices. The primary aim is to demonstrate substantial equivalence in image quality and clinical usefulness between the two imaging approaches.
Who should consider this trial
Good fit: Adults aged 22 or older with diagnosed retinal pathology who need FA and/or ICGA, have best-corrected visual acuity of 20/400 or better, and can tolerate ophthalmic imaging are ideal candidates.
Not a fit: Patients who cannot tolerate imaging, who have media opacities that prevent acceptable OCT scans, or whose vision is worse than study limits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the VG200D could provide clinicians with an alternative OCTA imaging option that offers comparable visualization of retinal blood vessels, supporting diagnosis and monitoring.
How similar studies have performed: Prior comparative work of OCTA versus FA/ICGA has shown promising but variable concordance depending on disease and imaging area, so this study builds on partially validated methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects 22 years of age or older on the date of informed consent * Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent * BCVA 20/400 or better in the study eye * Diagnosis of retinal associated pathology by investigator with the need to have an FA and/or ICGA performed in at least one eye Exclusion Criteria: * Subjects unable to tolerate ophthalmic imaging * Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons * Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Where this trial is running
Houston, Texas
- Retina Consultants of Texas — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Mike Sinai, PhD
- Email: mike.sinai@intalight.com
- Phone: 6198067636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.