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Swedish Microinvasive Glaucoma Surgery Study (SMIGS) (SMIGS)

Primary Purpose

Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Cataract surgery

KDB

Istent

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Eye clinic at the hospital of OstersundRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Cataract surgery as stand alone

Cataract surgery in combination with Kahook Dual Blade glide goniotomy

Cataract surgery in combination with iStent Inject W implantation

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Change in the number of intraocular pressure lowering medications compared to baseline

Accountability of intraocular pressure lowering medications used by the patient

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)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT05035394

First Posted

August 27, 2021

Last Updated

October 26, 2022

Sponsor

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT05035394

Brief Title

Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 16, 2021 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide, Istent Inject W, MIGS, Goniotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cataract surgery as stand alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cataract surgery in combination with Kahook Dual Blade glide goniotomy

Arm Type

Active Comparator

Arm 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.

Arm Title

Cataract surgery in combination with iStent Inject W implantation

Arm Type

Active Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Cataract surgery

Other Intervention Name(s)

Phacoemulsification, Cataract Surgery as stand-alone

Intervention Description

Cataract Surgery in a standardized fashion

Intervention Type

Procedure

Intervention Name(s)

KDB

Other Intervention Name(s)

Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA, KDB glide

Intervention Description

Goniotomy with KDB glide will be performed at the end of Cataract Surgery

Intervention Type

Procedure

Intervention Name(s)

Istent

Other Intervention Name(s)

iStent inject W, Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California

Intervention Description

Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery

Primary Outcome Measure Information:

Title

Change in the number of intraocular pressure lowering medications compared to baseline

Description

Accountability of intraocular pressure lowering medications used by the patient

Time Frame

12 to 24 months

Title

Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline

Description

Intraocular pressure measured by Goldmann applanation tonometry (GAT)

Time Frame

12 to 24 months

Secondary Outcome Measure Information:

Title

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

Description

Intraocular pressure measured by Goldmann applanation tonometry (GAT)

Time Frame

12 to 24 months

Other Pre-specified Outcome Measures:

Title

Number of participants that need further surgery

Description

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

Time Frame

12 to 24 months

Title

Number of participants that need additional medical therapy

Description

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

Time Frame

12 to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Barkander, MD

Phone

0730277070

Ext

+46

anna.barkander@regionjh.se

First Name & Middle Initial & Last Name or Official Title & Degree

Gauti Johannesson, MD, PhD

Phone

070-2200798

Ext

+46

gauti.johannesson@umu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Barkander, MD

Organizational Affiliation

Hospital of Ostersund, department of Ophtalmology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye clinic at the hospital of Ostersund

City

Ostersund

State/Province

Östersund

ZIP/Postal Code

83183

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Barkander

Phone

+46730277070

anna.barkander@regionjh.se

12. IPD Sharing Statement

Plan to Share IPD

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Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

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