Comparison of conjunctival edema after strabismus surgery by threads

JRCT ID: jRCT1062220091

Registered date:30/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Strabismus
• Date of first enrollment: 13/10/2023
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Strabismus surgery using nylon thread, a monofilament non-absorbable thread (control group), and polyglactin 910 thread, a multifilament absorbable thread (intervention group) (anterior translocation method [Plication method])

Outcome(s)

• Primary Outcome: Conjunctival edema thickness (mm) at 1 week postoperatively

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hamasaki Ichiro