iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Goniotomy with KDB blade goniotomy, Two iStent inject implanation.
- Who it may be relevant to
- Registry conditions: Open Angle Glaucoma (OAG). Basic parameters: from 18 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
Overview
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.
Detailed 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).
Interventions
- Device Goniotomy with KDB blade goniotomy
Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision. - Device Two iStent inject implanation
The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.
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]
- Intraocular pressure measured by Goldmann applanation tonometry (GAT) [Time frame: From enrollment to the end of treatment at 12 months]
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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 2 centers
- Medical University of Bialystok — Bialystok
- Ophthalmology Clinic Medical University of Bialystok — Bialystok
Identifiers
NCT: NCT07325552 · 1779