Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Cataract Clinical Trial

— COILEH  

Official title:

A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635020
• Other study ID #: 123123
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 2033

Study information

• Verified date: November 2020
• Source: Helsinki University Central Hospital
• Contact: Eeva Ojanen, MD
• Phone: +358503608589
• Email: eeva.ojanen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: September 2033
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Exfoliation Glaucoma
• Exfoliation Syndrome
• Glaucoma

Intervention

Procedure:
• iStent
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
• SLT-laser
1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
• Cataract surgery
Conventional cataract surgery

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Group I and II: Number of patients with secondary glaucoma surgery	Number of patients with secondary glaucoma surgery at 10 years from baseline is counted	10 years
Primary	Group I: Change in the number of IOP lowering medications compared to baseline	Accountability of IOP lowering medications used by the patient	12 months
Primary	Group II: Change in the IOP compared to baseline	IOP measured by Goldmann aplanation tonometry (GAT)	12 months
Secondary	Group I: Change in the IOP compared to baseline	IOP measured by GAT	12 months
Secondary	Group II: Change in the number of IOP lowering medications compared to baseline	Accountability of IOP lowering medications used by the patient	12 months