Abstracts
Background Provocation tests are widely used in allergology to objectively reveal patients’ sensitivity to specific allergens. The objective quantification of an allergic reaction is a crucial characteristic of these tests. Due to the absence of objective quantitative measurements the conjunctival provocation test (CPT) is a less frequently used method despite its sensitivity and simplicity. We developed a new method AllergoEye based on AI for quantitative evaluation of conjunctival allergic reactions and validated it in a clinical study.
Methods AllergoEye was implemented as a two component system. The first component is based on an Android smartphone camera for screening and imaging the patient’s eye and the second one is PC based for image analysis and quantification. For the validation of AllergoEye an open-label, prospective, monocentric study was carried out on 41 patients. Standardized CPT was performed with sequential titration of grass allergens in 4 dilutions with the reaction evaluated by subjective/qualitative symptom scores and by quantitative AllergoEye scores.
Results AllergoEye demonstrated high sensitivity (98%) and specificity (90%) as compared with human-estimated allergic reaction. Tuning cut-off thresholds allowed to increase the specificity of AllergoEye to 97%, where the correlation between detected sensitivity to allergen and sIgE CAP-class becomes obvious. Strikingly, such correlation was not found with sensitivity to allergen detected by subjective and qualitative symptom scores.
Conclusion The clinical validation demonstrated that AllergoEye is a sensitive and efficient instrument for objective measurement of allergic reactions in CPT for clinical studies as well as for routine therapy control.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
This study did not receive any funding
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study was approved by the Ethics Committee (IEC) of the State Chamber of Physicians of Saxony, Germany (IEC number EK-BR-111/21-1)
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Footnotes
Section discussion is updated Paper formatted for submission in International Archives of Allergy and Immunology
Data Availability
All data produced in the present study are available upon reasonable request to the authors