Randomised controlled trial on the efficacy(Outcome)of Kahook dual blade goniotomy assisted MIGS versus I- stent implantation(Intervention) in patients with open angle glaucoma in Indian population(Participants)

Randomised controlled trial on the efficacy of Kahook dual blade goniotomy assisted MIGS versus I- stent implantation in patients with open angle glaucoma in Indian population - OKAIS TRIAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098817

Enrollment

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: KAHOOK DUAL BLADE GONIOTOMY: Kahook Dual Blade (KDB) goniotomy is a minimally invasive surgical procedure for treating open-angle glaucoma. It uses a specialized dual-blade device to pr

Eligibility

Inclusion criteria

Inclusion criteria: i. Diagnosis of open-angle glaucoma( mild, moderate and advanced),according to Hodapp-Parrish-Anderson criteria,namely primary open angle glaucoma, pseudo-exfoliation glaucoma, pigmentary glaucoma. ii. Age greater than 40 years iii. Baseline IOP greater than 18 mmHg and less than 30 mmHg on current glaucoma medication(s) iv. Stable glaucoma medication regimen for at least 3 months prior to enrolment v. Visually significant cataract (more than 6/12 or worse) eligible for concurrent phacoemulsification.

Exclusion criteria

Exclusion criteria: i. Angle-closure glaucoma or secondary glaucomas (e.g., neovascular, uveitic) ii. Previous glaucoma surgery (excluding laser trabeculoplasty) iii. Significant ocular comorbidities (e.g., retinal detachment, macular degeneration) that may confound IOP measurements or visual outcomes. iv. Systemic conditions that may increase surgical risk or affect IOP (e.g., active uveitis, uncontrolled diabetes) v. Inability to provide informed consent or comply with study procedures.

Design outcomes

Primary

Measure	Time frame
To compare the mean change in IOP( greater than 20 percent) from baseline to 12 months post-operatively between the KDB goniotomy group and the I-Stent implantation group.Timepoint: 0, 12 months	—

Secondary

Measure	Time frame
To compare the reduction in mean number of glaucoma medications(more than 1 ) used at baseline, 1, 6 and 12 months post-operatively between the two groups.Timepoint: 1,6,12 months;Cost effective analysis between the two interventionsTimepoint: Nil;To assess the safety profiles of both procedures by comparing the incidence and severity of adverse eventsTimepoint: Nil	—

Countries

India

Contacts

Public ContactABHAY SOLANKI

Army hospital research and referral

sanjusonu_2000@yahoo.com9811551327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026