Dry Eye Disease
Conditions
Interventions
Suspected Dry Eye Syndrome with Allergic Conjunctivitis Group:None
Suspected Dry Eye Syndrome Group:None
Control Group:None
Suspected Infectious Conjunctivitis Group:None
Suspected Allergic Conjunctivitis Group:None
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Suspected Dry Eye Group:? Participants must meet all? of the following criteria, aged 8-70 years, regardless of gender, and must meet the diagnostic criteria of TFOS DEWS III: 1. Presence of at least one subjective symptom such as ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, or fluctuating vision; 2. OSDI-6 score >=4 and non-invasive tear film break-up time (NIBUT) >10 seconds; 3. No dry eye-related medication (including secretagogues and immunosuppressants) within 14 days prior to enrollment; no dry eye-related physical therapy (including hot compress, fumigation, lid margin cleaning, massage, intense pulsed light, and punctal occlusion) within 30 days prior to enrollment; no fluorescein sodium staining of the ocular surface within 24 hours. (Patients who use only artificial tears are eligible if they have not used them on the day of the visit.); 4. Signed written informed consent. Suspected Allergic Conjunctivitis Group: Participants must meet all? of the following criteria, aged 8-70 years, regardless of gender, and must meet the diagnostic criteria outlined in the "Expert Consensus on Diagnosis and Treatment of Allergic Conjunctivitis in China (2018)": 1. Presence of at least one subjective symptom, such as eye itching, which may be accompanied by foreign body sensation and increased conjunctival secretion, with or without a history of other allergic conditions; 2. Slit-lamp examination revealing at least one of the following: conjunctival hyperemia, conjunctival papillae, or specific corneal lesions; 3. No treatment for allergic conjunctivitis (including antihistamines, mast cell stabilizers, glucocorticoids, immunosuppressants, and artificial tears) within 14 days prior to enrollment; no ocular physical therapy (including cold compress and ocular cleaning) within 30 days prior to enrollment; no fluorescein sodium staining of the ocular surface within 24 hours. 4. Signed written informed consent. Suspected Infectious Conjunctivitis Group: Participants meeting any one? of the following criteria are eligible for enrollment, aged 8-70 years, regardless of gender: 1. Presence of at least one typical symptom such as eye redness, foreign body sensation, increased secretion, tearing, or photophobia; 2. Slit-lamp examination revealing at least one infection-related sign such as conjunctival hyperemia, conjunctival edema, tarsal conjunctival follicles or papillary hyperplasia, subconjunctival hemorrhage, or preauricular lymphadenopathy; 3. No use of topical or systemic antibiotics or antiviral drugs within 14 days prior to enrollment; no fluorescein sodium staining of the ocular surface within 24 hours. 4. Signed written informed consent. Suspected Dry Eye with Allergic Conjunctivitis Group: Must meet the diagnostic criteria for both dry eye and allergic conjunctivitis concurrently. Control Group: Participants must meet all? of the following criteria, aged 8-70 years, regardless of gender: 1. No history of dry eye disease and absence of subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or fluctuating vision; 2. No history of allergic conjunctivitis, allergic rhinitis, or other allergies; 3. No symptoms of eye redness, eye pain, or increased secretion within the past 30 days; 4. OSDI-6 score of 10? seconds; 4. No use of any ocular medications within 14 days prior to enrollment; 5. No ocular physical therapy within 3
Exclusion criteria
Exclusion criteria: Suspected Dry Eye Syndrome Group: 1. Presence of ocular diseases other than dry eye syndrome, allergic conjunctivitis, or infectious conjunctivitis; 2. Coexistence of other ocular conditions, except where dry eye syndrome and allergic conjunctivitis may coexist; 3. Females who are pregnant, breastfeeding, or planning to become pregnant; 4. Patients with a history of eyelid dysfunction or facial nerve paralysis; 5. Patients with a history of uncontrolled systemic diseases (excluding Sjögren's syndrome or other rheumatic diseases); 6. History of ocular surgery within 6 months prior to screening; 7. History of contact lens wear within 30 days prior to enrollment; 8. Any condition deemed by the investigator as unsuitable for participation in this clinical trial; 9. Patients unable to cooperate with tear collection or related examinations. Suspected Allergic Conjunctivitis Group: 1. Presence of ocular diseases other than dry eye syndrome, allergic conjunctivitis, or infectious conjunctivitis; 2. Coexistence of other ocular conditions, except where dry eye syndrome and allergic conjunctivitis may coexist; 3. Females who are pregnant, breastfeeding, or planning to become pregnant; 4. Patients with a history of eyelid dysfunction or facial nerve paralysis; 5. Patients with a history of uncontrolled systemic diseases (excluding Sjögren's syndrome or other rheumatic diseases); 6. History of ocular surgery within 6 months prior to screening; 7. History of contact lens wear within 30 days prior to enrollment; 8. Any condition deemed by the investigator as unsuitable for participation in this clinical trial; 9. Patients unable to cooperate with tear collection or related examinations. Suspected Infectious Conjunctivitis Group: 1. Presence of ocular diseases other than dry eye syndrome, allergic conjunctivitis, or infectious conjunctivitis; 2. Coexistence of other ocular conditions, except where dry eye syndrome and allergic conjunctivitis may coexist; 3. Females who are pregnant, breastfeeding, or planning to become pregnant; 4. Patients with a history of eyelid dysfunction or facial nerve paralysis; 5. Patients with a history of uncontrolled systemic diseases (excluding Sjögren's syndrome or other rheumatic diseases); 6. History of ocular surgery within 6 months prior to screening; 7. History of contact lens wear within 30 days prior to enrollment; 8. Any condition deemed by the investigator as unsuitable for participation in this clinical trial; 9. Patients unable to cooperate with tear collection or related examinations. Suspected Dry Eye Syndrome with Allergic Conjunctivitis Group: 1. Presence of ocular diseases other than dry eye syndrome, allergic conjunctivitis, or infectious conjunctivitis; 2. Coexistence of other ocular conditions, except where dry eye syndrome and allergic conjunctivitis may coexist; 3. Females who are pregnant, breastfeeding, or planning to become pregnant; 4. Patients with a history of eyelid dysfunction or facial nerve paralysis; 5. Patients with a history of uncontrolled systemic diseases (excluding Sjögren's syndrome or other rheumatic diseases); 6. History of ocular surgery within 6 months prior to screening; 7. History of contact lens wear within 30 days prior to enrollment; 8. Any condition deemed by the investigator as unsuitable for participation in this clinical trial; 9. Patients unable to cooperate with tear collection or related examinations. Control Group: 1. Females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Signs;Concentration of tear biomarkers; | — |
Countries
China
Contacts
Public ContactLingyi Liang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed