Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455683
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-28
Brief Title:
The A D A G I O Study
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
The Effect of Glaucoma Surgery on Aqueous Dynamics in Patients With Glaucoma or Ocular Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None