Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2021-09-16
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cataract surgery as stand alone
Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.
Cataract surgery
Cataract Surgery in a standardized fashion
Cataract surgery in combination with Kahook Dual Blade glide goniotomy
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.
KDB
Goniotomy with KDB glide will be performed at the end of Cataract Surgery
Cataract surgery in combination with iStent Inject W implantation
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.
Istent
Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
Interventions
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Cataract surgery
Cataract Surgery in a standardized fashion
KDB
Goniotomy with KDB glide will be performed at the end of Cataract Surgery
Istent
Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Umeå University
OTHER
Responsible Party
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Anna Barkander
Principal Investigator
Principal Investigators
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Anna Barkander, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Ostersund, department of Ophtalmology
Locations
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Eye clinic at the hospital of Ostersund
Östersund, Östersund, Sweden
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-02970
Identifier Type: -
Identifier Source: org_study_id
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