At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Feasibility of the Cornea DomeLens Ocular Surface Imaging System
In Brief
An observational study for Eyes Dry Chronic and 9 related conditions. Completed, enrolled 104 participants across 1 site.
Detailed Summary
Ocular surface photography is significantly limited in standardization and reproducibility. This reduces its applicability for clinical monitoring of acute or chronic disease. The innovative lens and illumination design of the CDL system aims to yield standardized high resolution photographs of the cornea and conjunctiva as required for clinical documentation, posing a significant clinical benefit of health care providers in the field of ophthalmology. Primary objectives: The primary objective of this study is to test the safety and feasibility of the CDL imaging system in a clinical routine setting. This will include the comparison of subjective contrast sensitivity testing post imaging, and the measurement of examination duration per imaging session, and the comparison of image lightness in mesopic versus photopic imaging. Secondary objectives: The secondary objective of this study is to compare the image quality of the device and repeatability of lateral resolution, dynamic range, hue, saturation, lightness, and image position between colour photographs from a state-of the art slit lamp camera and the CDL system. This is a monocentric, prospective, observational study. Patients with ocular surface disease of variable aetiology routinely assigned to ocular surface photography, following informed consent, will be imaged using state-of-the-art colour photography and the CDL imaging system. Pictures of each patient will be taken under several standardized conditions with both methods, subsequently analysed and compared by a Medical Image Processing Specialist.