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A study on the cognitive illusion of patients' dissatisfaction with the therapeutic effect of the LIPIFLOW thermal pulsation system

A study on the cognitive illusion of patients' dissatisfaction with the therapeutic effect of the LIPIFLOW thermal pulsation system

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128352
Enrollment
Unknown
Registered
2026-07-17
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye

Interventions

Patients who were subjectively dissatisfied after LIPIFLOW treatment (VAS satisfaction score = 80):None

Sponsors

Wuhan Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient knows and agrees to participate in this experiment, and can cooperate to complete the whole process of this experiment examination and treatment, with commitment to return to the doctor on time; 2. Age >= 18 years, regardless of gender or race; 3. Should have at least one of the following subjective symptoms: dry eyes, foreign body sensation, burning sensation, fatigue, discomfort, fluctuation of vision; 4. Slit-lamp examination showed at least one of the following signs: (1) palpebral margin congestion; (2) irregular palpebral margin, blunt palpebral margin, thickened palpebral margin; (3) meibomian gland opening is blocked or meibomian gland lipid thrombus can be seen in the opening; (4) gray line shift; 5. DEQ-5 questionnaire was used to investigate the subjective dry eye symptoms of patients, and the total symptom score should be >= 6 points; 6. The 15 glands of the lower eyelid of each eye were evaluated, and the lipid score of the secretion of the meibomian gland was <= 12 points; 7. SIT <= 5 mm; 8. BUT <= 5 s; 9. LLT <= 60 nm.

Exclusion criteria

Exclusion criteria: 1. Age < 18 years old; pregnant and lactating women; 2. Inflammation of the eyelid and eyelid skin; cicatricial lesions in eyelid, palpebral conjunctiva and bulbar conjunctiva; any eyelid abnormalities that affect the function of that eye or both eyes; 3. Previous chemical burns, recurrent corneal epithelial erosion, corneal epithelial defects, severe corneal fluorescein staining (grade 3), corneal dystrophy, and other ocular surface abnormalities that may affect corneal integrity in either eye; 4. Dry eyes caused by systemic or systemic immune diseases such as Stevens-Johnson syndrome, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, Wegner granuloma, sarcoidosis, leukemia, vitamin A deficiency, etc.; 5. The subject is unwilling or unable to stop certain medications known to cause dry eye (e.g., antihistamines) 1 month before receiving treatment; eye diseases associated with increased treatment impairment; 6. Meibomian gland photography found that more than 50% of meibomian gland glands were missing under either eyelid; 7. Had undergone eye surgery 3 months before baseline examination, especially any form of lacrimal embolization or lacrimal tubuloplasty; 8. Participated in other ophthalmic clinical trials 30 days before baseline examination.

Design outcomes

Primary

MeasureTime frame
Treatment Satisfaction Score;Eye Comfort Score,ECS;Semi-structured interviews;Information bias and cognitive illusion tests;Meibomian gland secretory capacity score;Trait score of meibomian gland secretions;Time to tear film rupture;Tear production;

Secondary

MeasureTime frame
Five-item Dry Eye Questionnaire;Best Corrected Visual Acuity;Intraocular Pressure;

Countries

China

Contacts

Public ContactTu Yuan

Wuhan Aier Eye Hospital

284057089@qq.com+86 189 7162 0291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026