Health Condition 1: H409- Unspecified glaucoma
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Elisar Vision Technology
Eligibility
Inclusion criteria
Inclusion criteria: 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 Controls 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. Glaucoma 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.
Exclusion criteria
Exclusion criteria: Phase 1 - Normative Database collection Ophthalmic 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. Systemic 1. History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis. 2. A life threatening or debilitating disease. Phase 2 - Comparison Data Controls: 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. Glaucoma : 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to collect a normative database of Macula thickness, Ganglion cell thickness, Retinal nerve fibre layer thickness and optic disc measurement for Elisar NOA.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of this study is to compare various measurements of retinal layers between Elisar NOA & the Cirrus 5000. The measurement parameters are listed in the protocol below with the indicating limits for the comparison.Timepoint: 15 weeks | — |
Countries
India
Contacts
Public ContactDr S Soundari
Dr Agarwals Eye Hospital
Outcome results
None listed