Dream OCT: testing a new eye imaging scanner

Performance Evaluation of Dream OCT: AP Study

This project tests a new swept-source OCT scanner (VG200D) by comparing its eye measurements to a standard device (Cirrus 5000) in adults with healthy eyes, glaucoma, retinal disease, or corneal abnormalities.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Intalight, Inc (Industry-sponsored)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07355491 on ClinicalTrials.gov

What this trial studies

This prospective, single-site comparison will image enrolled adults using both the investigational VG200D swept-source OCT and the predicate Cirrus 5000. Imaging will include anterior segment measures (cornea and epithelial thickness) and posterior segment measures (retina, ganglion cell + IPL, RNFL, and optic nerve). The study will analyze agreement and precision of measurement parameters and compare results to pre-determined performance goals. Evidence for substantial equivalence will require equivalent precision between devices and meeting agreement targets for a majority of parameters.

Who should consider this trial

Good fit: Ideal candidates are adults (22+) who can tolerate ophthalmic imaging and have either normal eyes, glaucoma, retinal pathology, or corneal abnormalities and meet the study's vision and exam criteria.

Not a fit: Patients who cannot tolerate imaging, who have media opacities that prevent acceptable OCT images, or who meet exclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the VG200D could offer clinicians equally reliable OCT measurements with potential advantages of swept-source technology, such as deeper tissue penetration or faster scans.

How similar studies have performed: Prior device-comparison and swept-source OCT studies have generally shown comparable or improved imaging performance versus older spectral-domain systems, though device-specific equivalence still needs confirmation.

Eligibility criteria

Inclusion Criteria for Normal Group:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
4. BCVA 20/40 or better (each eye) on the date of the study visit

Exclusion Criteria for Normal Group:

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
3. 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
4. Presence of any ocular pathology except for cataract in either eye

Inclusion Criteria for Glaucoma Group:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. BCVA 20/40 or better in the study eye
4. History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:

   1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
   2. Glaucoma hemi-field test "outside normal limits."
5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

   1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
   2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

Exclusion Criteria for Glaucoma Group:

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
3. 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
4. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard or Fast, 10-2, white on white) result within the past year of the study visit, defined as fixation losses \> 33%, or false positives \> 33%, or false negatives \> 33% in the study eye

Inclusion Criteria for Retina Disease Group:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. BCVA 20/400 or better in the study eye
4. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atrophy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, Vein or artery Occlusions and others

Exclusion Criteria for Retinal Disease Group:

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
3. 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

Inclusion Criteria for Cornea Group:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects with one of the following corneal abnormalities:

   i. Cornea disease (e.g., Fuch's or other) ii. Keratoconus iii. Cornea transplant iv. Post refractive surgery (e.g., LASIK or other) v. Dry Eye Syndrome vi. Long-term contact wearers (greater than 1 year)
4. BCVA 20/400 or better in the study eye

Exclusion Criteria for Cornea Group:

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
3. 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

Chicago, Illinois

• Illinois College of Optometry — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Micahel Chaglasian, OD — Illinois College of Optometry
• Study coordinator: Mike Sinai, PhD

Conditions Glaucoma Patients; Retina Patients; Eyes With Corneal Abnormality; Normal Healthy Eyes; Eyes with ocular pathology and normal healthy eyes