Protocol for Elisar NOA Data collection for Normative database and Comparison. - NI

Elisar Vision Technology0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Phase 1 Normative Database Collection
•1.Best corrected visual acuity of 20/40 or better in both eyes.
•2.IOP less than or equal to 21mmHg.
•3. No history of ocular, neurological, or systemic diseases that might affect the visual system.
•4. Normal visual field, indicated by a glaucoma hemifield test within normal limits, and MD and PSD greater than 5% probability level.
•Phase 2 Comparison Data
•1.Best corrected visual acuity of 20/40 or better in both eyes.
•2.IOP less than or equal to 21mmHg.
•3. No history of ocular, neurological, or systemic diseases that might affect the visual system.
•4. Normal visual field, indicated by a glaucoma hemifield test within normal limits, and MD and PSD greater than 5% probability level.
•1. A definitive diagnosis of glaucoma, defined as glaucomatous visual field loss with
•an accompanying optic nerve abnormality typical of glaucoma.
•2. The glaucoma needed to be stable, and the patient required at least two reliable
•SITA Standard 24-2 HVF examinations.

•Phase 1 - Normative Database collection
•1. Refractive error (spherical equivalent) outside –12.00 D to +8.00 D range.
•2. Glaucoma or glaucoma suspect diagnosis in either eye.
•3. Presence or history of ocular hypertension (IOP greater than 22 mm Hg) in either eye.
•4. Occludable angle or history of angle closure in either eye.
•5. Presence or history of disc hemorrhage in either eye.
•6. Presence of RNFL defect in either eye.
•7. Presence of amblyopia in either eye.
•8. Previous laser or incisional surgery.
•9. Any active infection of anterior or posterior segments.
•10. Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo–retinal disease.
•1. History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension,
•dementia or multiple sclerosis.
•2. A life threatening or debilitating disease.
•Phase 2 - Comparison Data
•1. History of glaucoma or any other ocular disease or systemic disease such as diabetes and images were also excluded if they had unusable OCT scans due to poor signal strength (lesser than 6) or algorithm failure.
•1. Any history of previous retinal disease such as macular degeneration or optic nerve disease, including non-glaucomatous optic neuropathy.
•2. Both normal and glaucoma images were also excluded if they had unusable OCT scans due to poor signal strength (lesser than 6) or algorithm failure, in which the boundaries for the RNFL layer were not delineated correctly.

发起方

Elisar Vision Technology