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Randomized, Parallel, Controlled, Single-Center Clinical Trial of Long-Acting Corneal Protectant for Corneal Epithelial Protection in Ophthalmic Surgery

Randomized, Parallel, Controlled, Single-Center Clinical Trial of Long-Acting Corneal Protectant for Corneal Epithelial Protection in Ophthalmic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122582
Enrollment
Unknown
Registered
2026-04-15
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Corneal epithelial defect

Interventions

Experimental group:Long acting corneal protectant
Control group:The 'corneal protector' produced by Valeant Med Sp.zo.o.

Sponsors

Eye Hospital of Shandong First Medical University (Shandong Eye Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing ophthalmic surgery who require corneal epithelial protection; 2.Subjects aged 18 to 80 years, with no gender restriction; 3.Subjects who voluntarily agree to participate in this clinical trial and have signed the Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: 1.Patients who have participated in other clinical trials within the past one month; 2.Pregnant or lactating women; 3.Patients with a known hypersensitivity to hypromellose; 4.Patients with corneal, conjunctival, eyelid, or lacrimal duct diseases; 5.Patients with diabetes mellitus; 6.Patients with severe dry eye in the operative eye; 7.Patients with a Schirmer I test result of 0 in the operative eye 8.Patients with a history of corneal trauma in the operative eye; 9.Patients who have undergone ophthalmic surgery in the operative eye within the past three months; 10.Patients who, in the investigator’s opinion, are unsuitable for enrollment due to other reasons.

Design outcomes

Primary

MeasureTime frame
Corneal fluorescein staining;Break-up Time;Success rate of optical clarity maintenance;Schirmer I test;

Secondary

MeasureTime frame
Product optical clarity retention time;Instillation frequency;Dosage per instillation;

Countries

China

Contacts

Public ContactWang Ting

Eye Hospital of Shandong First Medical University (Shandong Eye Hospital)

wt-ting@163.com+86 138 6918 2795

Outcome results

None listed

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