Effect of different concentrations of Mitomycin-C in Trabeculectomy on Corneal Endothelial Cell Density and Morphology-A Randomised Controlled Trail

Effect of different concentrations of Mitomycin -C aagumented trabeculectomy on Corneal Endothelial Cell Density and Morphology-A Randomised Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108436

Enrollment

Registered

2026-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: H401- Open-angle glaucoma Health Condition 2: H401- Open-angle glaucoma

Interventions

Intervention1: Mitomycin C: CONCENTRATION 0.1% mg/dl Intervention2: Mitomycin c: Different concentrations 0.1mg /ml Control Intervention1: Endothelial cell density and morphology: Effect of different

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Primary open angle glaucoma or primary angle closure requiring trabeculectomy clear cornea suitable for specular microscopy assessment preoperatively ability to comply with follow up

Exclusion criteria

Exclusion criteria: Conjunctival pathologies causing scarring in the superior conjunctiva. Patients who have undergone previous intraocular surgeries eg. trabeculectomy, selective laser trabeculoplasty (except uncomplicated cataract surgery performed more than 6 months prior) Presence of corneal diseases such as dystrophies, degenerations, or active keratitis. Pre-existing low endothelial cell density (1500 cells/mm ). Eyes with uveitis, neovascular, or traumatic glaucoma. Systemic diseases known to affect wound healing (e.g., uncontrolled diabetes mellitus, connective tissue disorders). -Pregnant or breastfeeding women will be excluded from the study. -Patients with known allergy to MMC. -Anterior segment and posterior segment pathologies that could affect IOP measurement like penetrating keratoplasty, refractive surgery, keratoconus non- glaucomatous optic neuropathy, proliferative or non-proliferative diabetic retinopathy, vascular occlusion will also be excluded.

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the effect of different concentrations of mitomycin-C (0.1and 0.2 mg/mL) used during trabeculectomy on corneal endothelial cell density.Timepoint: 18 months	—

Secondary

Measure	Time frame
To assess the morphological changes (polymegathism and pleomorphism) in corneal endothelial cells after trabeculectomy with different concentrations of mitomycin-C. To analyze the association between mitomycin -C concentration and postoperative complications of trabeculectomy.Timepoint: 18 months	—

Countries

India

Contacts

Public ContactDr Suvashika Dhingra

Aiims Bathinda

dranuradha_sagar@yahoo.com9899676415

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026