Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Umeå University

Status: Active, not recruiting

Conditions: Kahook Dual Blade Glide; Cataract; Istent Inject W; Goniotomy; Open Angle Glaucoma; MIGS

Treatments: Procedure: KDB; Procedure: Istent; Procedure: Cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05035394

2021-02970

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Cataract surgery as stand alone

Active Comparator group

Description:

Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.

Treatment:

Procedure: Cataract surgery

Cataract surgery in combination with Kahook Dual Blade glide goniotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: KDB

Cataract surgery in combination with iStent Inject W implantation

Active Comparator group

Description:

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.

Treatment:

Procedure: Istent