iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment (iSKDB)

Medical University of Bialystok

Status: Enrolling

Conditions: Open Angle Glaucoma (OAG)

Treatments: Device: Two iStent inject implanation; Device: Goniotomy with KDB blade goniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07325552

1779

Details and patient eligibility

About

The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.

Full description

Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only one eye per participant
• Clinically significant cataract
• Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
• Open chamber angle with Schaffer grading three to four in at least two quadrants

Exclusion criteria

• Previous glaucoma surgery, including cyclodestructive procedures.
• Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
• Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
• Unable to participate and make written consent due to another medical condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Procedure: KDB

Active Comparator group

Description:

Cataract surgery combined with Kahook Dual Blade goniotomy.

Treatment:

Device: Goniotomy with KDB blade goniotomy

Procedure: iStent

Active Comparator group

Description:

Cataract surgery in combination with iStent Inject W implantation

Treatment:

Device: Two iStent inject implanation