A comparative clinical study to determine equivalence and precision of measurement parameters in ophthalmic images obtained from PRIMUS 300 and CIRRUS 5000 HD OCT imaging devices.

Not Applicable

• Registration Number: CTRI/2019/11/022048
• Lead Sponsor: Carl Zeiss India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For inclusion, as normal subject, both eyes (OD & OS) must fulfill all of the following

criteria

1.Males or females 18 years of age or older

2. No history and evidence of retinal pathology or glaucoma

Retinal disease subjects (any eye OD or OS must meet any of the

criteria)

1.Males or females 50 years of age or older with diagnosis of active or recurrent neovascular age-related macular degeneration with presence of either drusen, pigment epithelial detachment or choroidal neovascularisation

2.Males or females 18 years of age or older with diagnosis of persistent diabetic macular

edema or cystoid macular edema or proliferative diabetic retinopathy

3.Males or females 18 years of age or older, with diagnosis of macular hole or vitreomacular

traction

4. Males or females 18 years of age or older with diagnosis of either sub-retinal fluid

(neurosensory detachment), subretinal hemorrhage, intraretinal atrophy, RPE disruption and tear, lamellar holes, exudates, fibrotic disciform scar, ischemic tissue, intra-retinal hemorrhage, vitreous hemorrhage, vascular occlusive disease, central serous retinopathy, epiretinal membranes, or other retinal disease

Glaucoma Subjects (any eye, OD or OS)

1.Males or females 18 years of age or older, with a diagnosis of glaucoma of any type,

ranging from early to advanced stage

Exclusion Criteria

Exclusion criteria

1. Best spectacle corrected visual acuity worse than 20/40 in either eye (normal subjects

only)

2.Inability to clinically view the optic discs due to media opacity or poorly dilating pupil

3.Unable to understand and follow the instructions on study procedures

4. Unable to cooperate for study procedures, specifically in terms of fixation

5.Unable to sit upright in front of the device

6.Presence of tremor, pathological rotational nystagmus and dyspnea

7. Any active infection of anterior or posterior segments

8.Unable to return for the required study visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference databaseTimepoint: 4 Months

Secondary Outcome Measures

Name	Time	Method
To determine the repeatability and reproducibility of PRIMUS 300 macular thickness, <br/ ><br>ganglion cell analysis, RNFL thickness & ONH measurementsTimepoint: 4 Months