Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.

Conditions
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Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide, Istent Inject W, MIGS, Goniotomy

Intervention / Treatment
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* Procedure: Cataract surgery
* Procedure: KDB
* Procedure: Istent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cataract surgery as stand alone<br>Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion. | Procedure: Cataract surgery<br>* Cataract Surgery in a standardized fashion<br>* Other names: Cataract Surgery as stand-alone;|
| Active Comparator: Cataract surgery in combination with Kahook Dual Blade glide goniotomy<br>Cataract surgery combined with Kahook Dual Blade Glide goniotomy. The goniotomy will be performed at the end of cataract surgery through the temporal cataract incision. | Procedure: KDB<br>* Goniotomy with KDB glide will be performed at the end of Cataract Surgery<br>* Other names: KDB glide;|
| Active Comparator: Cataract surgery in combination with iStent Inject W implantation<br>Cataract surgery combined with iStent Inject W. The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision. | Procedure: Istent<br>* Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery<br>* Other names: Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of intraocular pressure lowering medications compared to baseline | Accountability of intraocular pressure lowering medications used by the patient | 12 to 24 months | 
| Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline | Intraocular pressure measured by Goldmann applanation tonometry (GAT) | 12 to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 to 24 months |