Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

  • STATUS
    Recruiting
  • End date
    Sep 26, 2033
  • participants needed
    285
  • sponsor
    Helsinki University Central Hospital
Updated on 26 January 2021

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. Patients 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).

Details
Condition Cataract, Cataracts, Exfoliation Syndrome, Cataracts, pseudoexfoliation glaucoma
Treatment cataract surgery, iStent, SLT-laser
Clinical Study IdentifierNCT04635020
SponsorHelsinki University Central Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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