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NCT Number: NCT05035394

Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Open Angle Glaucoma Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Goniotomy Istent Inject W Kahook Dual Blade Glide Lens Diseases MIGS Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye clinic at the hospital of Ostersund

Östersund, 83183, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cataract surgery

Procedure

Cataract Surgery in a standardized fashion

Other names: Phacoemulsification, Cataract Surgery as stand-alone

KDB

Procedure

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

Istent

Procedure

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

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg

    Time frame: 12 to 24 months

    Intraocular pressure measured by Goldmann applanation tonometry (GAT)

Other outcomes

  1. Number of participants that need further surgery

    Time frame: 12 to 24 months

    Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser

  2. Number of participants that need additional medical therapy

    Time frame: 12 to 24 months

    Assessment of the need for future medical therapy in the study groups

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study 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.

Acronym: SMIGS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 5, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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