Safety and Feasibility of the Cornea DomeLens Ocular Surface Imaging System

Number of Patients: 100 participants will be enrolled. It is expected that 80% of enrolled patients will be assessed more than once during the study period. Based on an historic analysis of ambulatory visits it is estimated that the mean overall number of study visits will be 2.6 per patient with a range from 1 to 12, resulting in an overall number of study visits of 260(100 first visits and 160 follow-up visits).

Sample size justification: The present study was designed to detect a difference in mean loss of contrast sensitivity post CDL imaging of 1 letter (letter maximum: 48) compared to slit lamp photography (mean group slit lamp 1 letter with SD 1.75, mean group CDL 2, alpha 0.05, beta 0.2, power 0.8). The resulting sample size was 96.Regarding the principal secondary endpoint of repeatability, photography will be repeated 3 times with both devices. This study design allows the conclusion on repeatability of both devices. Based on clinical experience, the investigators expect a difference in repeatability of images between the two devices of approximately 15%. With this difference the required sample size to detect a significant difference without type I or II error is 150. Incidence of not repeatable images with CDL -group 1(5%). Incidence of not repeatable images with camera slit lamp -group 2 (20%). Alpha (0.05), Beta (0.2), Power (0.8).

General Study Procedure and Assessment Schedule A clinical examination using slit lamp biomicroscopy will be undertaken by experienced cornea and ocular surface specialists. Best corrected visual acuity and contrast sensitivity will be tested. Detailed notes of the live assessment will be made of all patients using the provided case report form (CRF).This will include patient demographics (age, sex), previous ocular history, previous medical history, concomitant medication, best corrected visual acuity, history of allergies. Particular note will be made of any conjunctival, limbal or corneal abnormalities, biomicroscopic grading of conjunctival redness using Efron's grading scale, and biomicroscopic grading of corneal punctate staining using the Oxford grading scale. Imaging will be performed with a total of 12images per eye performed by one trained operator at each study visit. Of these 12 images, 6 will be taken with state of the art slit lamp photography, and 6 will be taken with the CDL system. Of the 6 images per system, three will be taken at mesopic room conditions and three at photopic room light conditions. Every series of three photographs will be timed. Any study patient who is routinely scheduled for repeated ocular surface photographs during the study period will also receive repeated CDL and slit lamp imaging at consecutive clinical visits. Following the imaging session, contrast sensitivity will be tested 30 min after the photo session. Obtained colour photographs will be anonymized, coded, and exported to a password-locked hard drive in raw format and assigned to image analysis. Any image analysis will be performed by the data and image analysis team at Occyo.

Documentation The accomplishments of the study in agreement with the EN ISO 14155-2020 guidelines, the MD and the clinical investigational plan as well as the trueness of all data documented in the CRF are the responsibility of the Investigator. All collected data of this study have to be recorded in the CRF by appropriate authorized persons. This is also valid for data of patients, who dropped-out of the study. The Investigator records the participation in a special identification list of patients. This list gives the possibility of a later identification of the patients and contains the patient number, full name, date of birth and the date of the enrolment in the study. The identification list of patients remains in the study center after the closure of the study. Additionally, the participation of the patient in this clinical study has to be recorded in the patient chart (investigational device, number of patient, start and end of the study).Further it has to be assured, that this person, who is responsible for the documentation in the CRF, can be identified. A delegation of responsibilities log with signatures and identification code of the persons, who are allowed to make entries in the CRF, will be archived in the Study Master File.

Data Recording (CRF/eCRF): First point of data entry for all study relevant parameters will be the patient file (Source data). In accordance with the clinical routine and routine data capturing, specific study related data points will be treated as direct entries in the CRF and subsequently archived according to local regulations.