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Study on the efficacy of diquafosso sodium eye drops in the treatment of mild to moderate dry eye syndrome after SMILE and FS-LASIK

Study on the efficacy of diquafosso sodium eye drops in the treatment of mild to moderate dry eye syndrome after SMILE and FS-LASIK

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074418
Enrollment
Unknown
Registered
2023-08-07
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

dry eye

Interventions

Group A1:SMILE?Routine medication
Group B1:SMILE?Diquafosso sodium eye drops
Group A2:Routine medication
Group B2:Diquafosso sodium eye drops

Sponsors

Ethics Committee of the Eye Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-35 years old; 2. The research eye meets the conditions of FS-LASIK or SMILE surgery (in line with the "Expert Consensus on Clinical Diagnosis and Treatment of Laser Corneal Refractive Surgery (2015)" or "Expert Consensus on the Surgical Specifications of Corneal Stromal Lens Removal with Femtosecond Laser Small Incision in China (2018)"); 3. Preoperative diagnosis of normal or mild dry eye by refractive surgery (in line with the "Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020)"); 4. Diopter =-6D, cylindrical lensity =5D (high myopia is more likely to occur dry eye, "Chinese corneal refractive surgery perioperative dry eye diagnosis and treatment experts")

Exclusion criteria

Exclusion criteria: 1. Those who have a history of allergy to the test drug or its ingredients or cannot tolerate adverse reactions; 2. Previous eye disease, surgical history, ocular trauma and systemic disease; 3. Patients who have participated in other clinical trials within 1 month before surgery, and have used drugs that affect ocular surface function within 6 months before surgery; 4. Pregnant and lactating women, or women planning to become pregnant during the course of the study

Design outcomes

Primary

MeasureTime frame
Uncorrected visual acuity (UCVA);Dioptric;Tear break up time (TBUT);

Secondary

MeasureTime frame
Tear meniscus height;Fluorescent (FL);Ocular Surface Disease Index, (OSDI);Corneal central thickness;Corneal nerve density;

Countries

China

Contacts

Public ContactJi Peng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

ji6605@126.com+86 135 7375 3812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026