Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

  • STATUS
    Recruiting
  • End date
    Sep 5, 2027
  • participants needed
    120
  • sponsor
    Umeå University
Updated on 5 October 2021
hypertension
cataract
glaucoma
brimonidine tartrate ophthalmic solution
glaucoma surgery
Accepts healthy volunteers

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.

Description

Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).

Details
Condition Open Angle Glaucoma, MIGS, Goniotomy, Istent Inject W, Cataracts, Kahook Dual Blade Glide, Glaucoma, Cataract, Pigmentary glaucoma
Treatment cataract surgery, iStent, KDB
Clinical Study IdentifierNCT05035394
SponsorUmeå University
Last Modified on5 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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