Open Angle GlaucomaNCT06455683
The A D A G I O Study
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Glaucoma Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Glaucoma/OHT patients with sub-optimal intraocular pressure on multiple topical medications who require glaucoma surgical intervention to manage uncontrolled IOP.
Who may be able to join
- 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).
Who cannot join
- 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.
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Glaucoma Surgery on Aqueous Dynamics in Patients With Glaucoma or Ocular Hypertension
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)
Read the detailed description
There are currently many surgical options for patients with glaucoma and ocular hypertension (OHT), including 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. However, little is known about how these different surgical techniques used to treat glaucoma affect the flow of fluid through and out of the eye (aqueous dynamics).
One hundred and fifty patients with open angle glaucoma or OHT who are deemed to require glaucoma surgery clinically will be included in a prospective interventional study to investigate the effect of a number of surgical interventions (as listed above) for glaucoma on aqueous dynamics and also to investigate the influence of baseline aqueous dynamics on the eventual outcome of the different surgical techniques. The contralateral non-operated eye will be used as control where possible.
Participants will undergo pre-operative baseline measurement of aqueous dynamics parameters (intraocular pressure (IOP), aqueous flow rate, tonographic outflow facility) 2-8 weeks after stopping to use their eye drops for glaucoma. This stopping of glaucoma drops, or treatment 'washout', is considered an intervention as it deviates from the participants' usual care. Intraocular pressure will be measured using an ocular response analyser (ORA), the outflow facility will be measured by electronic Schiøtz tonography, and the aqueous flow rate will be measured by fluorophotometry. The uveoscleral outflow will be calculated using the Goldmann equation.
Measurement of aqueous dynamics parameters will be repeated 3 months and 12 months after surgery at post-operative follow-up appointments. The follow-up measurements of aqueous dynamics parameters will also be made after 2-8 weeks treatment washout where participants have to continue to use medication for their glaucoma after the surgery. Paired student t-tests will be used to compare aqueous dynamics parameters before and after surgery.
A number of additional eye test procedures will also be performed to collect data for the study at the pre-operative baseline appointment and at routine post-operative follow-up assessments 3 months and 12 months post-surgery. Other data will be collected from eye tests that are routinely performed at the pre-operative appointment and at post-operative follow-up appointments: 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.
All the additional non-routine tests will be performed as part of standard clinical ophthalmological assessments that are routinely utilised in the ophthalmology department.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Glaucoma Surgery
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma SurgeryProcedure or surgery
One of 5 Types of Interventions will be performed
- 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
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Glaucoma or Ocular Hypertension patients with sub-optimal intraocular pressure (IOP) on multiple topical medications Receives: Procedure: Glaucoma Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5 years
Secondary outcomes (2)
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)
Measured: 5 years
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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455683
- Sponsor's protocol ID
- 333763
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glaucoma Surgery on Aqueous Dynamics in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06455683
- Acronym / sponsor ID
- 333763
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
There are currently many surgical options for patients with glaucoma and ocular hypertension (OHT), including 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. However, little is known about how these different surgical techniques used to treat glaucoma affect the flow of fluid through and out of the eye (aqueous dynamics).
One hundred and fifty patients with open angle glaucoma or OHT who are deemed to require glaucoma surgery clinically will be included in a prospective interventional study to investigate the effect of a number of surgical interventions (as listed above) for glaucoma on aqueous dynamics and also to investigate the influence of baseline aqueous dynamics on the eventual outcome of the different surgical techniques. The contralateral non-operated eye will be used as control where possible.
Participants will undergo pre-operative baseline measurement of aqueous dynamics parameters (intraocular pressure (IOP), aqueous flow rate, tonographic outflow facility) 2-8 weeks after stopping to use their eye drops for glaucoma. This stopping of glaucoma drops, or treatment 'washout', is considered an intervention as it deviates from the participants' usual care. Intraocular pressure will be measured using an ocular response analyser (ORA), the outflow facility will be measured by electronic Schiøtz tonography, and the aqueous flow rate will be measured by fluorophotometry. The uveoscleral outflow will be calculated using the Goldmann equation.
Measurement of aqueous dynamics parameters will be repeated 3 months and 12 months after surgery at post-operative follow-up appointments. The follow-up measurements of aqueous dynamics parameters will also be made after 2-8 weeks treatment washout where participants have to continue to use medication for their glaucoma after the surgery. Paired student t-tests will be used to compare aqueous dynamics parameters before and after surgery.
A number of additional eye test procedures will also be performed to collect data for the study at the pre-operative baseline appointment and at routine post-operative follow-up assessments 3 months and 12 months post-surgery. Other data will be collected from eye tests that are routinely performed at the pre-operative appointment and at post-operative follow-up appointments: 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.
All the additional non-routine tests will be performed as part of standard clinical ophthalmological assessments that are routinely utilised in the ophthalmology department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Procedure: Glaucoma SurgeryGlaucoma or Ocular Hypertension patients with sub-optimal intraocular pressure (IOP) on multiple topical medications |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Glaucoma/OHT patients with sub-optimal intraocular pressure on multiple topical medications who require glaucoma surgical intervention to manage uncontrolled IOP.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glaucoma 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 | Procedure or surgery | Glaucoma |
Primary outcome
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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)
2 secondary outcomes
Number of participants with treatment related adverse events
Time frame: 5 years
Change in medication status from baseline
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kin Sheng Lim, MD FRCOphth (02071884885, sheng.lim@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.