Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide, Istent Inject W, MIGS, Goniotomy
Conditions
Brief summary
The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to 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 as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).
Interventions
PROCEDURECataract surgery
Cataract Surgery in a standardized fashion
PROCEDUREKDB
Goniotomy with KDB glide will be performed at the end of Cataract Surgery
PROCEDUREIstent
Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 | 12 to 24 months | Accountability of intraocular pressure lowering medications used by the patient |
| Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline | 12 to 24 months | Intraocular pressure measured by Goldmann applanation tonometry (GAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg | 12 to 24 months | Intraocular pressure measured by Goldmann applanation tonometry (GAT) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that need further surgery | 12 to 24 months | Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser |
| Number of participants that need additional medical therapy | 12 to 24 months | Assessment of the need for future medical therapy in the study groups |
Countries
Sweden
Outcome results
None listed