MedDataX Logo

Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

NCT ID: NCT04635020

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2033-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exfoliation Glaucoma Cataract

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

SLT iStent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stable glaucoma iStent

Cataract surgery combined with iStent inject

Group Type EXPERIMENTAL

iStent

Intervention Type PROCEDURE

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

Cataract surgery

Intervention Type PROCEDURE

Conventional cataract surgery

Stable glaucoma SLT-laser

Cataract surgery combined with SLT-laser 1 month after surgery

Group Type EXPERIMENTAL

SLT-laser

Intervention Type PROCEDURE

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

Cataract surgery

Intervention Type PROCEDURE

Conventional cataract surgery

Stable glaucoma

Cataract surgery

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Conventional cataract surgery

Unstable glaucoma iStent

Cataract surgery combined with iStent inject

Group Type EXPERIMENTAL

iStent

Intervention Type PROCEDURE

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

Cataract surgery

Intervention Type PROCEDURE

Conventional cataract surgery

Unstable glaucoma SLT-laser

Cataract surgery combined with SLT-laser 1 month after surgery

Group Type EXPERIMENTAL

SLT-laser

Intervention Type PROCEDURE

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

Cataract surgery

Intervention Type PROCEDURE

Conventional cataract surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iStent

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

Intervention Type PROCEDURE

SLT-laser

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

Intervention Type PROCEDURE

Cataract surgery

Conventional cataract surgery

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California Selective laser trabeculoplasty

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Mika Harju

MD, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mika Harju, MD, prof.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eeva Ojanen, MD

Role: CONTACT

Phone: +358503608589

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eeva Ojanen, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

123123

Identifier Type: -

Identifier Source: org_study_id