New eye scanner could sharpen diagnosis of glaucoma and retina diseases
NCT ID NCT07355491
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study is testing a new eye imaging device called the VG200D, which uses advanced technology to take detailed pictures of the eye. Researchers want to see if it works as well as a standard device for measuring parts of the eye in people with glaucoma, retina problems, corneal issues, and healthy volunteers. About 120 adults will be imaged with both devices to compare accuracy and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a more accurate and reliable imaging tool for diagnosing and monitoring eye diseases like glaucoma and retinal conditions.
- What could go wrong
- This is an early-stage observational study with only 120 participants, so results may not apply to everyone. The new device might not perform as well as expected or could have unknown issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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120 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population includes patients with normal healthy eyes, patients with glaucoma, patients with retina pathology and patients with abnormal corneas
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Illinois College of Optometry
Chicago, Illinois, 60616, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.