Health TrialsbyHealthPanel

iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

ConditionOpen Angle Glaucoma (OAG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Bialystok

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Goniotomy with KDB blade goniotomy

    Device

    Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.

  • Two iStent inject implanation

    Device

    The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Procedure: KDBActive comparator 1 intervention
Group B: Procedure: iStentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the number of intraocular pressure lowering medications compared to baseline

Accountability of intraocular pressure lowering medications used by the patient

Time frame
From enrollment to the end of treatment at 12 months
2

Intraocular pressure measured by Goldmann applanation tonometry (GAT)

Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline

Time frame
From enrollment to the end of treatment at 12 months

Secondary outcomes

1

Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg

Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months

Time frame
From enrollment to the end of treatment at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Bialystok

Lead sponsor

Source ClinicalTrials.gov
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