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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.

Comparison of macular thickness, ganglion cell analysis (GCA), retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) measurements of PRIMUS 300 and CIRRUS HD-OCT, Model 5000

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022048
Enrollment
165
Registered
2019-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: PRIMUS 300 HD OCT: The PRIMUS 300 is an ophthalmologic instrument, a class II medical device that provides functionality similar to CIRRUS 400, but with a separate manual patient interf
K181534) and is commercially released.

Sponsors

Carl Zeiss India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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 Inclusion criteria: 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 Inclusion criteria: 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: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To determine the repeatability and reproducibility of PRIMUS 300 macular thickness, ganglion cell analysis, RNFL thickness & ONH measurementsTimepoint: 4 Months—

Countries

India

Contacts

Public ContactDr T C Ganesh Babu

Carl Zeiss India (Bangalore) Pvt Ltd

ganesh.babu@zeiss.com9880225622

Outcome results

None listed

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