Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with primary or secondary open-angle glaucoma (e.g., POAG, pigmentary, pseudoexfoliative)
Scheduled for phacoemulsification with planned goniotomy
Able to provide informed consent
Disqualifiers
Angle-closure glaucoma
Prior glaucoma surgery in the study eye
Planned stand-alone goniotomy
Inability to comply with follow-up schedule
Trial design
Design model
Parallel
Treatments tested in this trial
Goniotomy
Procedure/SurgeryGoniotomy opens the trabecular meshwork to lower intraocular pressure.
Treatment groups
132 Participants
are divided into 3 treatment groupsGroup A: SIONActive comparator 1 intervention
Group B: BANGActive comparator 1 intervention
Group C: TanitoActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraocular pressure
Eye pressure as measured by Goldmann applanation tonometry in mmHg
Time frame
up to 6 months2
Medications
number of medications to control intraocular pressure
Time frame
up to 6 months3
Visual Acuity
Measure of visual at each visit on Snellen acuity chart
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: