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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05035394
Other study ID # 2021-02970
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2021
Est. completion date September 2027

Study information

Verified date November 2023
Source Umeå University
Contact Anna Barkander, MD
Phone 0730277070
Email anna.barkander@regionjh.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2027
Est. primary completion date September 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Sweden Eye clinic at the hospital of Ostersund Ostersund Östersund

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants that need further surgery Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser 12 to 24 months
Other Number of participants that need additional medical therapy Assessment of the need for future medical therapy in the study groups 12 to 24 months
Primary 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
Primary 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 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
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