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Protective effect of diquafosol sodium eye drops on ocular surface tissue during perioperative period of vitrectomy for diabetic retinopathy: a prospective, multicenter, randomized controlled trial

Protective effect of diquafosol sodium eye drops on ocular surface tissue during perioperative period of vitrectomy for diabetic retinopathy: a prospective, multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070172
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-04
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

diabetic retinopathy

Interventions

Group A (combined drug group):Diquafosol sodium eye drops and sodium hyaluronate eye drops were used 3 days before surgery, 1 drop/time, 3 times/day, until 1 month after surgery
Group B (monotherapy group):Sodium hyaluronate eye drops were used 3 days before surgery, 1 drop/time, 3 times/day until 1 month after surgery

Sponsors

Xuzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old; 2. Mild, moderate and severe dry eye; 3. Patients diagnosed with type 2 diabetes mellitus and scheduled for vitrectomy; 4. Preoperative blood glucose was well controlled, and fasting blood glucose was less than 8mmol/L 5. Patients voluntarily participated in the study, signed the informed consent form, and the compliance was good.

Exclusion criteria

Exclusion criteria: 1. Patients with severe dry eye; 2. History of mechanical ocular trauma or corneal refractive surgery or any other surgery affecting the integrity of the ocular surface structure 3. Patients with meibomian gland dysfunction, corneal disease, glaucoma, chronic dacryocystitis, lacrimal canaliculitis, eyelid entropion, eyelid ectropion and other ophthalmic diseases; 4. Patients with autoimmune diseases such as systemic lupus erythematosus, type I diabetes mellitus, Hashimoto's thyroiditis and rheumatoid arthritis; 5. Accompanied by serious primary diseases of the heart, kidney, lung, endocrine, blood or digestive system; 6. Patients with allergy or contraindications to study drugs; 7. Patients with concomitant ocular surface inflammation; 8. Patients with concomitant traction retinal detachment.

Design outcomes

Primary

MeasureTime frame
OSDI questionnaire survey;

Secondary

MeasureTime frame
Corneal fluorescein staining score;breakup time of tear film;

Countries

China

Contacts

Public ContactSuyan Li

Xuzhou First People's Hospital

lisuyan1226@126.com13852101775

Outcome results

None listed

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