The A D A G I O Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorGuy's and St Thomas' NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Glaucoma Surgery

    Procedure/Surgery

    One 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

150 Participants
are divided into 1 treatment group
Group A: Glaucoma1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
5 years
2

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)

Time frame
5 years
3

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)

Time frame
5 years
4

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)

Time frame
5 years

Secondary outcomes

1

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)

Time frame
5 years
2

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)

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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