NCT05035394

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Sep 2021Sep 2027

First Submitted

Initial submission to the registry

August 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

August 27, 2021

Last Update Submit

June 2, 2025

Conditions

Open Angle GlaucomaCataractKahook Dual Blade GlideIstent Inject WMIGSGoniotomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    12 to 24 months

Other Outcomes (2)

  • Number of participants that need further surgery

    12 to 24 months

  • Number of participants that need additional medical therapy

    12 to 24 months

Study Arms (3)

Cataract surgery as stand alone

ACTIVE COMPARATOR

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

Procedure: Cataract surgery

Cataract surgery in combination with Kahook Dual Blade glide goniotomy

ACTIVE COMPARATOR

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

Cataract surgery in combination with iStent Inject W implantation

ACTIVE COMPARATOR

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

Interventions

Cataract surgeryPROCEDURE

Cataract Surgery in a standardized fashion

Also known as: Phacoemulsification, Cataract Surgery as stand-alone
Cataract surgery as stand alone
KDBPROCEDURE

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

Also known as: Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA, KDB glide
Cataract surgery in combination with Kahook Dual Blade glide goniotomy
IstentPROCEDURE

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

Also known as: iStent inject W, Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California
Cataract surgery in combination with iStent Inject W implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye clinic at the hospital of Ostersund

Östersund, Östersund, 83183, Sweden

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleCataract

Interventions

Cataract ExtractionPhacoemulsification

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Anna Barkander, MD

    Hospital of Ostersund, department of Ophtalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

September 16, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)