Study for acquiring extended data on the clinical applicability of AllergoEye” (an AI-based software, CE certified) for the automatic redness determination of the sclera of the eye based on photographs. AllergoEye” as an aid in evaluating results of the conjunctival provocation test (KPT)

Conditions: J30.1
Allergic rhinitis due to pollen

Registration Number: DRKS00033338

Lead Sponsor: Praxis für HNO und Allergologie Dr. Yury Yarin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 47

Inclusion Criteria

Presence of a signed and dated informed consent form from the patient
-Presence of a suspected diagnosis of allergic rhinoconjunctivitis
-Patient is able to fill out the questionnaires
-Consent to subcutaneous or sublingual immunotherapy

Exclusion Criteria

-Current participation in other clinical trials
-Acute or chronic eye diseases especially all forms of conjunctivitis or glaucoma
-Severe acute and/or chronic organic or mental illness, including the presence of epilepsy
-Contraindications to SLIT/SCIT
-Inadequate method of contraception (double contraception is necessary)
-Pregnancy
-Chronic non-allergic rhinitis
-Intolerance to antihistamines and/or cortisone preparations
-Presence of type III and/or type IV allergy
-Current or expired complementary medical therapy as well as planned complementary medical therapy during the study period

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proof of the usability and effectiveness of the AllergoEye” system in diagnostics and during the three-year therapy in 50 patients with allergic rhinoconjunctivitis

Secondary Outcome Measures

Name	Time	Method
a. Confirmation that when comparing the results of the AllergoEye” with the subjective assessment of the medical staff, AllergoEye” demonstrates a better qualitative and quantitative performance.<br><br>b. Proof that the accuracy of the Summation Symptom Scores is qualitatively increased when using the AllergoEye” redness measurement instead of the subjective assessment by medical staff.<br><br>c. Proof that the results obtained by AllergoEye” correlate exactly with the Summation Symptom Scores and that AllergoEye” is therefore able to replace the complex, subjective methodology of the Summation Symptom Scores.