MGD-type dry eye
Conditions
Interventions
Experimental group:Treatment with ocular steaming combined with meibomian gland massage in a closed-eye state
Experimental group:Let the eyelids naturally open, performing eye steam therapy combined with meibomian gland massage in the eyes-open state
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Subjects with MGD-related dry eye disease are eligible for enrollment in this study only if they meet all of the following criteria: Meet the diagnostic criteria for Meibomian Gland Dysfunction (MGD) 1.In accordance with the 2017 Chinese Expert Consensus on Diagnosis and Treatment of MGD: (1) Abnormal eyelid margin and Meibomian gland orifices; (2) Abnormal Meibomian gland secretion; (3) Ocular symptoms including dryness, foreign body sensation, ocular pain, ocular pruritus, visual fluctuation, etc; (4) Thickened lipid layer; (5) Meibomian gland atrophy/loss; MGD can be diagnosed when either criterion (1) or (2) is satisfied, combined with criterion (3). Criteria (4) and (5) are supplementary diagnostic indicators. 2.Meet the diagnostic criteria for dry eye diseaseDiagnosed in accordance with the Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020):(1) Presence of one or more subjective ocular symptoms including dry eye, dry itching, foreign body sensation, burning sensation, ocular distension, visual fatigue, ocular redness, photophobia with lacrimation, ocular pain, visual acuity changes, etc.(2) Tear Break-Up Time (TBUT) =10 seconds(3) Schirmer I Test (SIT) =2 s; Moderate: Corneal lesions involving no more than 2 quadrants and/or =5 but =2 s; Severe: Corneal lesions involving >=2 quadrants and/or >=30 corneal fluorescein staining spots on slit-lamp examination, TBUT <2 s; corneal fluorescein staining spots coalesce into coarse spots, patches, or are accompanied by filaments. 3.Aged between 18 and 90 years old; 4.No adverse reactions to the experimental methods adopted in this study; 5.The subject fully understands the study and has signed an informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any one of the following criteria shall be excluded from this study: 1.Subjects with severe systemic diseases, including cardiovascular and cerebrovascular diseases, hepatic and renal dysfunction, hematological diseases, etc; 2.Subjects with inflammatory ocular diseases such as conjunctivitis, keratitis, scleritis, iritis in either eye, orbital structural abnormalities, or complicated with systemic autoimmune diseases; 3.Female subjects who are pregnant or breastfeeding; male and female subjects who plan to become pregnant during the study period or within 3 months after the completion of the study, or who refuse to adopt effective contraceptive measures; 4.Subjects who have undergone ocular surgery within the past 3 months; 5.Subjects who have participated in other clinical trials within 3 months prior to screening, or who intend to participate in other clinical trials during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular surface disease index,OSDI; Visual Analogue Scale;Tear break-uptime,TBUT;Corneal fluorescein staining,CFS;Schirmer test,SIt;Meibomian gland dropout score,MGDS;Meibomian glands yielding liquid secretion, MGYLS;Meibomian gland yielding secretion score, MGYSS;Tear film lipid layer thickness,LLT;Eyelid temperature; | — |
Countries
China
Contacts
Public ContactQing Zhang
The Second Hospital of Anhui Medical University
Outcome results
None listed