About this trial
This study aims to investigate the effect of different types of glaucoma surgery on aqueous dynamics parameters (IOP, aqueous flow rate, trabecular outflow facility and uveoscleral outflow) in patients with uncontrolled open angle glaucoma or ocular hypertension (OHT)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females between the ages of 18 and 90 (inclusive).
Able to understand the study and give informed consent.
Willing, able and available to participate in the study. If Flurophotometer test required must not have had prior cataract surgery.
Diagnosis of glaucoma or OHT which requires glaucoma surgery (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment). (Defined as primary or secondary glaucoma; all types of secondary glaucoma may be included. Glaucoma will be diagnosed based on abnormal visual field testing and corresponding disc changes once seen by a glaucoma specialist.)
Disqualifiers
Diagnostic criteria for inclusion not met.
Allergy to fluorescein.
It is judged as not clinically safe or patient is not willing to undergo treatment washout (stop taking glaucoma drops).
Current use of any investigational drug or device or current participation in an interventional clinical trial/study.
Trial population
Glaucoma/OHT patients with sub-optimal intraocular pressure on multiple topical medications who require glaucoma surgical intervention to manage uncontrolled IOP.
Trial design
Cohort
Prospective
Treatments tested in this trial
Glaucoma Surgery
Procedure/SurgeryOne of 5 Types of Interventions will be performed 1. Trans-trabecular meshwork surgery with or without an implant 2. Trans-scleral surgery with or without implant 3. Ciliary Body Treatment 4. Suprachoroidal surgery with or without implant 5. External Non Incisional Treatment
Treatment groups
Trial outcomes
Primary outcomes
To investigate the effect of different types of glaucoma surgery on aqueous dynamics parameters (Intraocular Pressure IOPcc/IOPg using Ocular Response Analyzer) in patients with uncontrolled glaucoma or OHT.
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
To investigate the effect of different types of glaucoma surgery on aqueous dynamics parameters (Trabecular outflow facility µL/min per mm Hg using digital schiøtz tonometer) in patients with uncontrolled glaucoma or OHT.
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
To investigate the effect of different types of glaucoma surgery on aqueous dynamics parameters (Aqueous flow rate μL/min using a flurophotometer) in patients with uncontrolled glaucoma or OHT.
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
To investigate the effect of different types of glaucoma surgery on aqueous dynamics parameters (Uveoscleral outflow μL/min using the Goldmann mathematical equation) in patients with uncontrolled glaucoma or OHT.
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
Secondary outcomes
Number of participants with treatment related adverse events
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
Change in medication status from baseline
Glaucoma surgery types (trans-trabecular meshwork surgery with or without an implant, trans-scleral surgery with or without implant, ciliary body treatment, suprachoroidal surgery with or without implant, external non-incisional treatment)
Locations
Sponsors and contacts
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