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Laser Myringotomy in Acute Otitis Media with Effusion: A Randomized Controlled Trial

Laser Myringotomy in Acute Otitis Media with Effusion: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190905001
Enrollment
80
Registered
2019-09-05
Start date
2020-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

acute otitis media with effusion otitis media with effusion laser myringotomy OME resolution

Interventions

Topical EMLA anesthetic cream is applied into the ear canal 45 minutes prior the procedure in both groups. Treatment group undergoes CO2 laser myringotomy under microscope in operating room with a po
single pulse duration 0.2 seconds and a scanned area of 1.9 millimeter in diameter. The middle ear fluid is removed as much as possible,intranasal corticosteroid 2 puff each nostril daily for 1 week.
CO2 Laser myringotomy,observation

Sponsors

Faculty of Medicine
Lead Sponsor
Chualongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patient aged 18&#45;70 years with OME < 3 months from the date of onset

Exclusion criteria

Exclusion criteria: 1. Craniofacial anomalies 2. Nasopharyngeal mass such as adenoid hypertrophy&#44; Nasopharyngeal carcinoma 3. Post&#45;radiation of head and neck tumor 4. Pregnancy women 5. Rhinosinusitis (>3months) with or without nasal polyp 6. Previous history of ventilation tube insertion

Design outcomes

Primary

MeasureTime frame
OME resolution time 12 weeks resolution time by normal physical examination&#44; pneumatic otoscope and Tympanogram type A

Secondary

MeasureTime frame
1. Cure rate of OME: treatment group and control group 12 weeks physical examination&#44; audiometry&#44; tympanometry,Time of symptoms resolution 12 weeks patient report ,complication of laser myringotomy 12 weeks physical examination,recurrence rate 12 weeks physical examination&#44; audiometry&#44; tympanometry

Countries

Thailand

Contacts

Public ContactPaninee Charusripan

Chulalongkorn University

paninee_c@hotmail.com0886484545

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026