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A study to understand the accuracy of the measured parameters on the same eye captured multiple times using a single device of Elisars NOA (repeatability) and understand the accuracy of the measured parameter on the same eye using multiple devices of Elisars NOA (reproducibility)

Protocol for Repeatability & Reproducibility of Elisars NOA - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066063
Enrollment
190
Registered
2024-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H259- Unspecified age-related cataract Health Condition 2: H409- Unspecified glaucoma

Interventions

Intervention1: Elisar-Novel Ophthalmic Analyzer: Prospective observational study to observe the repeatability and reproducibility of device parameters. Control Intervention1: NIL: NIL

Sponsors

Elisar Vision Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For Stage 1 Study Controls 1. Patients said to be clinically normal by an ophthalmologist. Cataract 1. Patients diagnosed with cataracts that are graded using the LOCS grading method by an ophthalmologist. 2. Eyes that are undergoing cataract surgery candidates in the clinic. For Stage 2 Study Controls 1. All subjects had no history of any ocular diseases, a fundus appearance should be normal. 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: For Stage 1 Study 1. Presence of keratoconus or suspect keratoconus, a previous diagnosis of dry eye, history of any corneal disease or trauma, any kind of ocular surgery, and use of contact lens past month. 2. Eyes with retinopathy or maculopathy, eyes with a history of corneal disease, pseudophakic eyes, Patients with corneal pathology, previous refractive surgery or abnormalities in the anterior segment. For Stage 2 Study Normal 1. a history of glaucoma or any other ocular disease or systemic diseases such as diabetes and images were also excluded if they had unusable OCT scans due to poor signal strength (less 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 (less than 6) or algorithm failure, in which the boundaries for the RNFL layer were not delineated correctly.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is to compare the repeatability and reproducibility of the biometry and OCT measurements in Elisar NOA by calculating the Standard deviation(SD) and limits for the repeated measurement and compare with the indicative limits.Timepoint: 12 weeks

Secondary

MeasureTime frame
NILTimepoint: NA

Countries

India

Contacts

Public ContactDr S Soundari

Dr Agarwals Eye Hospital

soundari404@gmail.com9840339659

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026