iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment
ID: NCT07325552
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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.
Read Full Scientific Objectives & Methods
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).
Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.
The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.
Treatment Arms Description
Cataract surgery combined with Kahook Dual Blade goniotomy.
Cataract surgery in combination with iStent Inject W implantation
- 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
- 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.
Primary Outcome Measures
- Change in the number of intraocular pressure lowering medications compared to baseline — Time Frame: From enrollment to the end of treatment at 12 months
Accountability of intraocular pressure lowering medications used by the patient
- Intraocular pressure measured by Goldmann applanation tonometry (GAT) — Time Frame: From enrollment to the end of treatment at 12 months
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
View Secondary Outcome Measures (1)
- Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg — Time Frame: From enrollment to the end of treatment at 12 months
Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months
This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 2 Facilities & Contact Sites
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View Official Medical/Scientific Title
iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma