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The efficacy and safety of 0.05% cyclosporine eye drops in the early postoperative period of FS-LASIK: A multicenter randomized controlled clinical trial

The efficacy and safety of 0.05% cyclosporine eye drops in the early postoperative period of FS-LASIK: A multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114411
Enrollment
Unknown
Registered
2025-12-11
Start date
2022-06-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Dry eye after refractive surgery

Interventions

Control group:combined treatment

Sponsors

Guangzhou Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1.Age: 20 to 30 years old; 2.The patient has a desire to remove glasses and has reasonable expectations for the surgical outcome; 3.Before the operation, the patient and their family must jointly sign the informed consent form after fully understanding the situation; 4.The refractive state has been basically stable (with an increase in myopia of no more than 50 degrees per year for at least 2 years; 5.For myopia or myopia combined with astigmatism patients, the equivalent spherical lens power is between -3.00D and -6.00D, and the astigmatism is no more than 2.00D. 6.Surgical method: FS-LASIK.

Exclusion criteria

Exclusion criteria: 1.History of ocular trauma, blepharitis, ocular infections unrelated to dry eye within 3 months prior to enrollment, filamentary keratitis; 2.Individuals with incomplete eyelid closure, or those who have undergone double eyelid surgery or other eyelid plastic surgeries; 3.Use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressants, or other medications that may interfere with the study within 1 month prior to the procedure; 4.Patients with known hypersensitivity to the medications used in this study; 5.Patients with severe primary diseases of the liver, kidney, hematopoietic system, or psychiatric disorders; 6.Patients unable to complete the 3-month follow-up; 7.Any condition deemed by the physician as ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index;Noninvasive breakup time,NIBUT;

Secondary

MeasureTime frame
Corneal fluorescein staining;Refraction status examination (subjective and objective);TMH /tear meniscus height;Vision (unaided vision + corrected vision);Eye redness index;Intraocular pressure;

Countries

China

Contacts

Public ContactWang Zheng

Guangzhou Aier Eye Hospital

wangzheng@aierchina.com+86 20 66289986

Outcome results

None listed

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