A clinical study to compare measurements of back side of eye (retina) from PRIMUS 300 and CIRRUS 400 medical device and to find out precision of PRIMUS 300

Not Applicable

• Conditions: Health Condition 1: null- Normal subjects, Subjects with known retinal disease and Subjects with glaucoma of any type

• Registration Number: CTRI/2018/04/013512
• Lead Sponsor: Carl Zeiss India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 133

Inclusion Criteria

For inclusion, as normal subject, both eyes (OD & OS) must fulfil 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 neovascularization

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

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