Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Cataract Clinical Trial

— SMIGS  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05035394
• Other study ID #: 2021-02970
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not 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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

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