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NCT05686421
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
Conditions: Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: NYU Langone Health
Location: United States
Summary
In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional OCT device with no invention attached.
The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.
Eligibility Criteria
Inclusion Criteria:Healthy volunteers; OR,AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye diseaseGroup-Specific Inclusion Criteria:-- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.Healthy VolunteersA normal clinical ophthalmic examination.Reliable VF, reproducible glaucoma hemifield tests labeled within normal limits on at least one test.Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and Ganglion Cell Inner Plexiform Layer (GCIPL) OCT, within normal limits.Primary Open Angle Glaucoma (POAG)Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect.Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with typical glaucomatous RNFL and GCIL thinning.Normal Tension Glaucoma (NTG)Identical to POAG criteria with IOP recorded at ≤ 21 mmHg at any time point.Exclusion Criteria:An individual who meets any of the following criteria will be excluded from participation in this study:- Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
Source: ClinicalTrials.gov (NCT05686421). StuddyBuddy aggregates publicly available trial information.