The efficacy and safety of trabeculectomy with mitomcyin C

The concentration of mitomycin C and wound healing reaction and safety in trabeculectomy with mitomycin C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004108

Enrollment

Registered

2019-07-01

Start date

2016-04-10

Completion date

Unknown

Last updated

2019-07-17

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

Conditions

None listed

Interventions

Drug : Patients eligible for the study were randomly assigned to the 0.2 mg / ml and 0.4 mg / ml groups according to the Mitomycin C concentration applied and topically applied mitomycin C to the bleb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with POAG, PACG, pseudoexfoliation glaucoma, or secondary glaucoma were screened. The inclusion criteria were age older than 20 years, and inadequate IOP control despite maximally tolerated medical therapy. In addition, eyes with IOP less than 21 mmHg while receiving medical therapy but with progressive optic nerve damage or visual field (VF) deterioration were included. Diagnosis of glaucoma was made based on an optic disc examination and the presence of a VF defect. Glaucoma eyes were defined as eyes showing glaucomatous optic disc appearances (i.e., neuroretinal rim thinning, notching, and/or retinal nerve fiber layer (RNFL) defects) and corresponding glaucomatous VF defects.

Exclusion criteria

Exclusion criteria: Exclusion criteria were patients with previous intraocular surgery except cataract operation and those with a known allergy to MMC. Patients with anterior-segment pathologic features that could affect IOP measurement (penetrating keratoplasty, keratoconus, refractive surgery) and posterior-segment pathologic features that could interfere with optic nerve head or VF assessment (non-glaucomatous optic neuropathy, diabetic retinopathy, vascular occlusion) were also excluded. In addition, patients with thrombocytopenia, coagulopathy, those receiving phenytoin as a yellow fever vaccine or prophylactic agent, and women with fertility who were pregnant or planned to become pregnant during the follow-up period were excluded. In cases where both eyes of a subject were eligible for the study, the eye that had undergone surgery first was chosen for inclusion.

Design outcomes

Primary

Measure	Time frame
Bleb grade score	—

Secondary

Measure	Time frame
Bleb grade score;Postoperative intraocular pressure and number of glaucoma medication;Suceess rate;postoperative complication and additional procedure	—

Countries

Korea, Republic of

Contacts

Public ContactBo Ram Seol

Seoul National University Hospital

gorong20@hanmail.net+82-2-2225-1890

Outcome results