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Surgery for lower eyelid epiblepharon in children: a multi-center randomized controlled trial.

Surgery for lower eyelid epiblepharon in children: a multi-center randomized controlled trial. - Surgery for lower eyelid epiblepharon in children: a multi-center RCT.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027321
Enrollment
50
Registered
2017-05-12
Start date
2017-04-01
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

lower eyelid epiblepharon

Interventions

Suture method without skin incision Modified Hotz procedure (with skin incision)

Sponsors

Yokohama City University Department of Ophthalmology
Lead Sponsor
Kanagawa Children&#39
Collaborator
s Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are 3 to 15 years of age with the keratopathy due to epiblepharon, who want to undergo a surgical treatment. When the ciliary touch is classified into three stages based on the previous report (Mild: contact with nasal conjunctiva, no corneal contact, Moderate: contact with nasal conjunctiva and cornea, Severe: contact with nasal conjunctiva, cornea and temporal conjunctiva), targeted to moderately relevant patients.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic syndrome. 2. Patients with facial anomalies / facial features abnormalities / eyelid tumors etc. that are thought to affect epiblepharon. 3. Patients who undergo surgery at the same time for upper epiblepharon or epicanthus. 4. Patients who have had a history of surgery on eyelids in the past. 5. Patients with abnormal lid closure, such as facial nerve paralysis, ptosis of the eyelids. 6. Traumatic epiblepharon. 7. Patients with keratoconjunctival disease not caused by epiblepharon. 8. Patients who can not respond to ophthalmologic examination mainly by slit lamp microscopy mainly due to the mental retardation. 9. Patients whose bleeding or scarring seems to be different from normal 10. Other patients who is unlikely to participate in the study, judge by the medical doctor.

Design outcomes

Primary

MeasureTime frame
Cure rate (1 month and 6 months after surgical) The severity of keratopathy and ciliary touch by slit-lump examination.

Secondary

MeasureTime frame
Recurrence rate, therapeutic effect, corneal shape, refraction, cosmetic, and safety. The severity of keratopathy and ciliary touch by slit-lump examination, corneal topography, auto refract mater, optical coherence tomography and photography.

Countries

Japan

Contacts

Public ContactTomoko Ohno

Yokohama City University Ophthalmology

ochan_tt@yahoo.co.jp045-787-2683

Outcome results

None listed

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