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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)

Not Applicable
Conditions
Health Condition 1: H259- Unspecified age-related cataractHealth Condition 2: H409- Unspecified glaucoma
Registration Number
CTRI/2024/04/066063
Lead Sponsor
Elisar Vision Technology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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