The A D A G I O Study

NCT06455683 | Not Yet Recruiting

• 1 other identifier: 333763
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (4)

• 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)

  5 years

• 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)

  5 years

• 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)

  5 years

• 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)

  5 years

Secondary Outcomes (2)

• Number of participants with treatment related adverse events

  5 years

• Change in medication status from baseline

  5 years

Study Arms (1)

Glaucoma

Glaucoma or Ocular Hypertension patients with sub-optimal intraocular pressure (IOP) on multiple topical medications

Procedure: Glaucoma Surgery

Interventions

Glaucoma Surgery PROCEDURE

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

Glaucoma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma/OHT patients with sub-optimal intraocular pressure on multiple topical medications who require glaucoma surgical intervention to manage uncontrolled IOP.

You may qualify if:

• 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.)
• It is judged clinically safe for the patient to undergo treatment washout (stop taking glaucoma drops).

You may not qualify if:

• 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.
• Participants in the study must be able to understand English to complete some of the tests so those who might not adequately understand written information or verbal explanations in English will not be included

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Central Study Contacts

Kin Sheng Lim, MD FRCOphth

CONTACT

02071884885; sheng.lim@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share