Swedish Microinvasive Glaucoma Surgery Study (SMIGS) (SMIGS)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract; Open Angle Glaucoma; MIGS; Kahook Dual Blade Glide; Istent Inject W; Goniotomy
• Intervention / Treatment: Procedure: Cataract surgery; Procedure: KDB; Procedure: Istent

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östersund
    • Ostersund, Östersund, Sweden, 83183
      • Eye clinic at the hospital of Ostersund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cataract surgery as stand alone; Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.	Procedure: Cataract surgery; Cataract Surgery in a standardized fashion; Other Names: Phacoemulsification; Cataract Surgery as stand-alone
Active Comparator: 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.	Procedure: KDB; Goniotomy with KDB glide will be performed at the end of Cataract Surgery; Other Names: Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA; KDB glide
Active Comparator: 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.	Procedure: Istent; Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery; Other Names: iStent inject W; Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Anna Barkander, MD, Hospital of Ostersund, department of Ophtalmology

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2021-02970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No