Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01297803

Enrollment

Unknown

Registered

2011-02-17

Start date

2010-11-30

Completion date

2011-12-31

Last updated

2011-02-17

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

Conditions

Glaucoma Patients Scheduled for Trabeculectomy

Brief summary

Application of antimetabolite agents such as mitomycin\_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin\_c can be applied remain a concern before or after sclera flap dissection. Mitomycin\_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin\_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin\_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Interventions

DRUGMitomycin_c

0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age Range between 18 to 80 years old * Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion criteria

* Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

Design outcomes

Primary

Measure	Time frame	Description
corneal endothelial cell density	six month	specular microscopy
corneal endothelial cell polymorphism	6 months	specular microscopy
corneal endothelial cell polymegathism	6 months	specular microscopy

Secondary

Measure	Time frame	Description
IOP (intra ocular pressure)	six months	applanation tonometry

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026