Open Angle Glaucoma (OAG)
Conditions
Keywords
glaucoma, iStent inject, Kahook Dual Blade goniotomy
Brief summary
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
DEVICEGoniotomy with KDB blade goniotomy
Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.
DEVICETwo iStent inject implanation
The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.
Sponsors
Medical University of Bialystok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Weeks to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of intraocular pressure lowering medications compared to baseline | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg | From enrollment to the end of treatment at 12 months | Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months |
Countries
Poland
Contacts
Primary ContactJoanna Konopinska
Outcome results
None listed