NCT04635020

Brief Summary

The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
89mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2020Sep 2033

Study Start

First participant enrolled

October 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Expected
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

October 29, 2020

Last Update Submit

November 17, 2020

Conditions

Exfoliation GlaucomaCataract

Keywords

SLTiStent

Outcome Measures

Primary Outcomes (2)

  • Group I: Change in the number of IOP lowering medications compared to baseline

    Accountability of IOP lowering medications used by the patient

    12 months

  • Group II: Change in the IOP compared to baseline

    IOP measured by Goldmann aplanation tonometry (GAT)

    12 months

Secondary Outcomes (2)

  • Group I: Change in the IOP compared to baseline

    12 months

  • Group II: Change in the number of IOP lowering medications compared to baseline

    12 months

Other Outcomes (1)

  • Group I and II: Number of patients with secondary glaucoma surgery

    10 years

Study Arms (5)

Stable glaucoma iStent

EXPERIMENTAL

Cataract surgery combined with iStent inject

Procedure: iStentProcedure: Cataract surgery

Stable glaucoma SLT-laser

EXPERIMENTAL

Cataract surgery combined with SLT-laser 1 month after surgery

Procedure: SLT-laserProcedure: Cataract surgery

Stable glaucoma

ACTIVE COMPARATOR

Cataract surgery

Procedure: Cataract surgery

Unstable glaucoma iStent

EXPERIMENTAL

Cataract surgery combined with iStent inject

Procedure: iStentProcedure: Cataract surgery

Unstable glaucoma SLT-laser

EXPERIMENTAL

Cataract surgery combined with SLT-laser 1 month after surgery

Procedure: SLT-laserProcedure: Cataract surgery

Interventions

iStentPROCEDURE

2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork

Also known as: Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California
Stable glaucoma iStentUnstable glaucoma iStent
SLT-laserPROCEDURE

1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)

Also known as: Selective laser trabeculoplasty
Stable glaucoma SLT-laserUnstable glaucoma SLT-laser
Cataract surgeryPROCEDURE

Conventional cataract surgery

Stable glaucomaStable glaucoma SLT-laserStable glaucoma iStentUnstable glaucoma SLT-laserUnstable glaucoma iStent

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed consent of information
  • Clinical significant cataract
  • Able to attend 12 month period
  • Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)
  • Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication
  • Target IOP ≥16
  • Able to understand Finnish, Swedish or English

You may not qualify if:

  • Clinical set target IOP \< 16 mmHg in advanced glaucoma
  • Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
  • Closed angle
  • Congenital angle anomaly
  • Clinically significant corneal dystrophy or other hindering corneal condition
  • Unable to use topical medical therapy
  • Central corneal thickness of less than 480um or more than 620um
  • Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.
  • Previous intraocular surgery, refractive surgery or cycloablation
  • Two or more prior SLT or laser trabeculoplasty
  • Unable to participate due to another medical disease or condition
  • Participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Exfoliation SyndromeCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mika Harju, MD, prof.

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eeva Ojanen, MD

CONTACT

+358503608589eeva.ojanen@hus.fi

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
MD, professor

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 18, 2020

Study Start

October 1, 2020

Primary Completion

September 1, 2023

Study Completion (Estimated)

September 1, 2033

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)