RecruitingNCT07355491
Performance Evaluation of Dream OCT: AP Study
Sponsor
Intalight, Inc
Enrollment
120 participants
Start Date
Dec 16, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
Eligibility
Min Age: 22 Years
Inclusion Criteria22
- 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
- Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
- BCVA 20/40 or better (each eye) on the date of the study visit
- 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 20/40 or better in the study eye
- 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:
- 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;
- Glaucoma hemi-field test "outside normal limits."
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- 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 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
- 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
- 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)
- BCVA 20/400 or better in the study eye
Exclusion Criteria14
- 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
- Presence of any ocular pathology except for cataract in either eye
- 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
- 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
- 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
- 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
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Interventions
DEVICEThis is an observational study only, all patients are imaged on the investigational device
This study is a non-significant risk study where enrolled patients are imaged on an investigational device and a predicate device
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07355491