Clinical trials: Normal Eyes
Normal Eyes
P200TE US Reference Database Study
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
- Trial name
- NCT05844852
- Testing
- P200TE
- Where
- 9 sites in United States
- Volunteers
- 954 people, healthy volunteers welcome
- Sponsor
- Optos, PLC
Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment
Heidelberg Engineering ANTERION Software Comparison Study
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
- Trial name
- NCT06657716
- Testing
- ANTERION investigational
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Normal Eyes, Age Related Macular Degeneration
High Resolution Imaging OCT Study
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.
- Conditions
- Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy, Eyes With Retinal Diseases
- Trial name
- NCT07338461
- Testing
- Autofluorescence Imaging, Infrared reflectance imaging, OCT imaging
- Where
- Italy
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
The Focus of This Study is to Collect OCT Data on Normal Eyes
Intalight Reference Database Protocol for VG200D
The goal of this study is to collect OCT scans on normal healthy eyes from an investigational OCT device the VG200D from Intalight, Inc, in order to establish a reference database.
- Trial name
- NCT07751484
- Testing
- OCT device called VG200D
- Where
- 3 sites in United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Intalight, Inc
Glaucoma Patients, Retina Patients
Performance Evaluation of Dream OCT: AP Study
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000.
- Conditions
- Glaucoma Patients, Retina Patients, Eyes With Corneal Abnormality, Normal Healthy Eyes
- Trial name
- NCT07355491
- Testing
- This is an observational study only, all patients are imaged on the investigational device
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Intalight, Inc
Normal Eyes
Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements
Evaluation of effect of various OCT scan speeds and filters on parameter measurements.
- Trial name
- NCT04961398
- Testing
- OCT imaging
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Retinal Vascular, Normal Eyes
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
- Trial name
- NCT03279939
- Testing
- OCT Angiography, Color Fundus Photography, Fluorescein Angiography
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Normal Eyes, Abnormal Eyes
Agreement and Precision Study of UNITY® DX and a Comparator Biometer
The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the…
- Trial name
- NCT06826599
- Testing
- Investigational Biometer, IOLMaster 700 Biometer
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Cylite Pty Ltd
Normal Eyes, Eye Abnormalities
The Heidelberg Engineering BI US Evaluation Study
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI
- Trial name
- NCT03578302
- Testing
- BI Anterior Segment Mode, BI Anterior Segment and IOL Biometry Mode
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment
The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
- Trial name
- NCT06397976
- Testing
- ANTERION investigational
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Eye Abnormalities, Normal Eyes
Agreement and Precision Study
To evaluate the performance of pachymetry function
- Trial name
- NCT06733428
- Testing
- Pachymeter
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Topcon Corporation
Retinal Vascular, Normal Eyes
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
- Trial name
- OCTA (NCT04604002)
- Testing
- OCT Angiography, Color Fundus Photography, Optical Coherence Tomography
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Normal Eyes
IMOvifa Perimeter Reference Database
This study will collect data to establish a reference database for the IMOvifa perimeter.
- Trial name
- NCT05792046
- Testing
- Visual field
- Where
- 4 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- New View Optometric Center
Eye Abnormalities, Normal Eyes
The Heidelberg Engineering ANTERION Imaging Agreement Study
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye
- Trial name
- NCT04068818
- Testing
- ANTERION
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Subjects Presenting With Normal Eyes
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
- Trial name
- NCT02447133
- Testing
- 3D OCT-1 Maestro
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes
Clinical Study of the Optic Disc Parameters
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices
- Conditions
- Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
- Trial name
- NCT02277119
- Testing
- Maestro, iVue
- Where
- 2 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Normal Eyes, Eyes With Glaucoma
OCT Agreement and Precision Study
To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the commercially available iVue and NW-300.
- Conditions
- Normal Eyes, Eyes With Glaucoma, Eyes With Retinal Disease
- Trial name
- NCT02045823
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes
Maestro Agreement and Precision Study II
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the Maestro and iVue OCT devices.
- Conditions
- Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
- Trial name
- NCT02376868
- Testing
- 3D OCT-1 Maestro, iVue
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN
Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
This prospective study was was divided into 2 parts and carried out at 2 sites in Germany. Part 1 assessed Repeatability in healthy, non-diabetic population (Group "control").
- Conditions
- Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN, Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN
- Trial name
- NCT05326958
- Testing
- HRT RCM, HRT RCM-E
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Heidelberg Engineering GmbH
Normal Eyes and Ocular Pathology
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
- Trial name
- OCT (NCT04437082)
- Testing
- optical coherence tomography
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Optovue