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Non-inferiority control study on the effect and safety of prolene-assisted 360 degree Trabeculectomy to treat childhood glaucoma

Non-inferiority control study on the effect and safety of prolene-assisted 360 degree Trabeculectomy to treat childhood glaucoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050149
Enrollment
Unknown
Registered
2021-08-19
Start date
2021-01-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Glaucoma

Interventions

Prolene group:prolene-assisted nealy 360° trabeculotomy
Microcatheter group:Microcatheter-assisted trabeculotomy

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 21mmHg, with glaucomatous optic disc neuropathy(a cup-to-disc ratio of > 0.6 or the presence of notching) or enlarged cornea with a diameter > 12mm; 3. uncontrolled IOP with maximal medications; 4. be able to finish the follow-up of 24 months.

Exclusion criteria

Exclusion criteria: 1. complicated with other congenital eye anomalies; 2. with a history of eye surgeries other than glaucoma surgery; 3. complicated with uncontrolled systemic diseases; 4. could not finish the whole-course follow-up.

Design outcomes

Primary

MeasureTime frame
visual acuity;intraocular pressure;optic cup/disc ratio;RNFL thickness;visual field;operative complications;medication;corneal diameter;—

Secondary

MeasureTime frame
axial length;—

Countries

China

Contacts

Public ContactHui Guo

Qilu Hospital of Shandong University

guohui@sdu.edu.cn+86 18560087106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026