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Comparison of conjunctival edema after strabismus surgery by threads

Comparison of the course of conjunctival edema in the plication method using nylon and polyglactin 910 threads

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062220091
Enrollment
64
Registered
2023-01-30
Start date
2023-10-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Strabismus

Interventions

Strabismus surgery using nylon thread, a monofilament non-absorbable thread (control group), and polyglactin 910 thread, a multifilament absorbable thread (intervention group) (anterior translocation

Sponsors

Morisawa Shin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i) Patients who will be seen between date of publication of implementation plan and March 31, 2025 (ii) Patients who are able to obtain written consent from themselves or a surrogate to participate in research of their own free will (iii) no age limit (iv) Patients whose age is less than 18 years old and whose family members have given their consent (v) Sex: male/female (vi) Target disease: Patients diagnosed with strabismus and scheduled for surgery to treat the horizontal rectus muscles (medial and lateral rectus muscles) (vii) Patients for whom anterior segment OCT has been determined to be measurable

Exclusion criteria

Exclusion criteria: i) Those with a history of previous ophthalmic surgery on the target muscle or surrounding muscle (adhesion) (ii) Those with other diseases affecting conjunctival edema (conjunctivitis, thyroid eye disease, post-retinal detachment buckling surgery, etc.) (iii) Patients who cannot cooperate in the examination, etc. due to intellectual disability, etc.

Design outcomes

Primary

MeasureTime frame
Conjunctival edema thickness (mm) at 1 week postoperatively

Secondary

MeasureTime frame
1. Conjunctival edema thickness at 1 month and 4 months postoperatively 2. Conjunctival edema thickness above and below the attachment site of the external ocular muscle to be measured at 1 and 4 months postoperatively 3. Safety and adverse events from the start of surgery to the end of the study 4. Thread failure at 1 and 4 months postoperatively 5. Degree of bleeding and hematoma at 1 month and 4 months postoperatively 6. Findings of granuloma, Dellen, etc. at 1 month and 4 months postoperatively 7. Ocular position at 1 month and 4 months postoperatively

Contacts

Public ContactAkemi Ueno

Okayama University Hospital

opth@cc.okayama-u.ac.jp+81-86-235-7297

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026