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Comparing the efficacy of two novel Minimally Invasive Glaucoma Surgeries in Open Angle Glaucoma

Comparative study of Interventional Valve Enhancing Trabeculotomy and Kahook Dual Blade Goniotomy with Phacoemulsification in Open Angle Glaucoma - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102550
Enrollment
140
Registered
2026-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Interventions

Intervention1: Phacoemulsification with IVEnT: Standard Phacoemulsification with IOL implantation followed by IVEnT Control Intervention1: Phacoemulsification with KDB: Standard Phacoemulsification wi

Sponsors

Aravind Eye Hospital Tirunelveli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Open angle glaucoma Mild to moderate (Primary open angle glaucoma Pseudo-exfoliative glaucoma Pigmentary glaucoma) with Visually significant cataract BCVA less than equal to 6/12 on snellens chart Vertical CD ratio less than equal to 0.8 Glaucomatous visual field defects with MD less than equal to -12dB Pre-op IOP more than 21mmHg or IOP more than 18 mm Hg with AGM Open angle confirmed by gonioscopy using 4 mirror gonioscopy lens Able and willing to attend scheduled follow up visits Able and willing to provide informed consent Non compliance to medication or not tolerating AGM

Exclusion criteria

Exclusion criteria: Prior Glaucoma surgery or laser Functionally severe field loss with a MD of more than -12 dB. Active ocular/ periocular inflammation Corneal abnormality that may interfere with visualization of angle structures Traumatic cataract. Retinal or optic nerve disorders that are not associated with existing glaucoma condition Elevated episcleral venous pressure One eyed patients

Design outcomes

Primary

MeasureTime frame
To evaluate the IOP lowering and Safety Profile of iVEnT combined with Phacoemulsification compared to KDB Goniotomy combined with Phacoemulsification in Open Angle Glaucoma PatientTimepoint: at 2 weeks 1 2 3 6 12 months

Secondary

MeasureTime frame
To assess the number of Antiglaucoma Medications required postoperatively To assess complications arising following the procedure To measure Schlemm s Canal Area and Width, Ciliary Muscle thickness at 1,2,3 mm from Scleral spur (CM1, CM2, CM3) using ASOCT (CASIA 2 machine). Timepoint: at 2 weeks 1 2 3 6 12 months

Countries

India

Contacts

Public ContactDr Devendra Maheshwari

Aravind Eye Hospital Tirunelveli

drdevmaheshwari@gmail.com9597483961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026