Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy (NCT06523751) | Clinical Trial Compass
RecruitingNot Applicable
Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy
Germany55 participantsStarted 2023-06-13
Plain-language summary
The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* individuals ≥ 18 years of age
* clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
* uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
* progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p \< 0.05)
* progression of visual field defects
* visually significant cataract and indication to reduce IOP or glaucoma medication burden
Exclusion Criteria:
* clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
* prior glaucoma surgery
* preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IOP
Timeframe: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
2
Outflow facility
Timeframe: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively