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To evaluate the efficacy and safety of Cycloome (0.05% cyclosporine eye drops II) after cataract surgery in patients with dry eye: a multicenter clinical study

To evaluate the efficacy and safety of Cycloome (0.05% cyclosporine eye drops II) after cataract surgery in patients with dry eye: a multicenter clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063490
Enrollment
Unknown
Registered
2022-09-08
Start date
2022-08-26
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Cataract with dry eye

Interventions

experimental group:0.05% Cyclosporine Eye Drops II (Cycloome)

Sponsors

Shenyang Air Excellence Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50-80 years; 2. Age-related cataract was diagnosed, and the indications for phacoemulsification (Phaco + IOL implantation) or femtosecond assisted cataract extraction surgery were met and the surgery was planned; 3. The preoperative diagnosis was dry eye, which met the diagnostic criteria of dry eye listed in the Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020): (1) The patient complained of one of the subjective symptoms such as ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness and visual fluctuation, with a score of >= 7 on the China Dry Eye Questionnaire or >= 13 on the Ocular Surface Disease Index (OSDI). At the same time, patients with FBUT = 7 on the China Dry Eye Questionnaire or >= 13 on the OSDI; At the same time, patients with FBUT > 5 s and 5 mm/5 min and = 5 spots) can be used to diagnose dry eye; 4. Sign the informed consent, and cooperate to complete the examination, treatment and follow-up for 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients at high risk of intraoperative or postoperative complications; 2. History of ocular trauma, blepharitis, eye infection unrelated to dry eye within 3 months from enrollment, filamentous keratitis; Severe dry eye, Sjogren's syndrome, allergic conjunctivitis, active ocular surface diseases, history of viral keratitis, history of corneal surgery, iritis, uveitis, history of corneal refractive surgery, pterygium, glaucoma, fundus diseases under treatment, systemic immune-related diseases, etc.; 3. Patients with incomplete eyelid closure, double eyelid surgery or other eyelid plastic surgery; 4. Use hormones, non-steroidal anti-inflammatory drugs, immunosuppressants and other drugs that may affect the study within 1 month before surgery; 5. Allergic to the drugs used in this study; 6. Patients with severe primary diseases of liver, kidney and hematopoietic system or mental disorders; 7. Failure to complete the 3-month follow-up; 8. Participating in other clinical trials or lost patients during follow-up; 9. The patient has any other conditions that the doctor considers impossible to enroll in the study. 10. Candidates who participated in clinical trials of other drugs or medical devices within 1 month before screening.

Design outcomes

Primary

MeasureTime frame
Keratograph;OSDI, ocular surface disease index;wave front aberration;

Countries

China

Contacts

Public ContactJinsong Zhang

Shenyang Air Excellence Eye Hospital

cmu4h-zjs@126.com+86 18900916888

Outcome results

None listed

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