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Comparing sodium hyaluronate effects on eye moisture after cataract surgery

Efficacy of 0.15% sodium hyaluronate on tear breakup time (TBUT), Schirmer's I test score, ocular surface disease index (OSDI) score, corneal staining score (CSS), lipid layer thickness (LLT) and meiboscore after cataract surgery: a randomized, double-masked study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95830348
Enrollment
60
Registered
2023-08-25
Start date
2022-05-11
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Dry eye syndrome, meibomian gland dysfunction Eye Diseases

Interventions

Patients are randomized using the random number method into two treatment groups. The first group will use 0.15% sodium hyaluronate ophthalmic solution (Hyalu Mini®, Hanmi P harma Inc., Seoul, Korea)

Sponsors

Pusan National University Yangsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Be male or female, aged 19 years to 90 years 2. Have a tear breakup time (TBUT) of 10 seconds or more 3. Have a Schirmer’s I test result of 10 mm or more 4. Have not used diquafosol-based eye drops, artificial tear drops, steroid eye drops, or antibiotic eye drops within 3 months before participation 5. Show normal blinking during a slit lamp exam 6. Voluntarily agree to participate in this study

Exclusion criteria

Exclusion criteria: 1. Has Sjögren's syndrome 2. Has severe blepharitis 3. Had ocular surgery or laser eye surgery 4. Has severe ocular inflammation/infection 5. Is using eye drop treatment for dry eyes, such as glaucoma or allergies 6. Shows sensitivity to the study drugs 7. Is considered to be ineligible for participation owing to reasons other than the aforementioned exclusion criteria based on the judgment of the principal researcher

Design outcomes

Primary

MeasureTime frame
Measured at baseline (1 week before cataract surgery) and 1, 3, 6 weeks after cataract surgery: 1. Ocular surface status parameters: 1.1. Lipid layer thickness (LLT) measured using an interferometer 1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc. 1.3. Tear breakup time (TBUT), corneal staining score(CSS), meiboscore were measured by an ophthalmologist 2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026