Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonathon Myers
About this trial
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Moderate to severe open angle glaucoma (including POAG, PG, and PXG)
Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9
Visual acuity HM or better
VF MD -6dB or worse
Disqualifiers
Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma
Previous incisional glaucoma surgery
ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days
Active ocular inflammation or edema, clinically significant corneal dystrophy
Trial design
Design model
Single group
Treatments tested in this trial
iStent infinite trabecular micro-bypass system model iS3
Devicesurgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
iDose TR (Travoprost intracameral Implant) 75mcg
Drugsurgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Surgery for patients with medically uncontrolled POAGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
IOP reduction from baseline
a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables.
Time frame
Diurnal IOP reduction from baseline at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov