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.
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Umeå University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
Time Frame: 12 to 24 months
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Change in the number of intraocular pressure lowering medications compared to baseline
Time Frame: 12 to 24 months
Accountability of intraocular pressure lowering medications used by the patient
Secondary Outcomes
- Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg(12 to 24 months)
Investigators
Anna Barkander
Principal Investigator
Umeå University