Corneal Endothelial Cell Loss After Trabeculectomy Versus Phakotrabeculectomy (NCT03107000) | Clinical Trial Compass
CompletedNot Applicable
Corneal Endothelial Cell Loss After Trabeculectomy Versus Phakotrabeculectomy
Canada25 participantsStarted 2017-09-01
Plain-language summary
Corneal endothelial cells health and pumping function is crucial to permit corneal optical clarity by keeping cornea in relatively dehydrated state. Corneal endothelial damage has been associated with most types of intraocular surgery. Trabeculectomy is the standard glaucoma surgical intervention in management of progressive glaucoma despite of medical therapy which can be performed in combination with Cataract surgery (Phacoemulsification and IOL implantation) in patients with cataract-impaired visual acuity.
In this study, the investigators will investigate and compare the corneal endothelial cells number and health status before and after trabeculectomy vs. combined surgery (at 1 month and 3 months post-op visits) using Specular microscopy which is a non-invasive technique to access the structure and function of the corneal endothelium by permitting visualization of the corneal endothelial mosaic to assess the effect of this surgical intervention on corneal endothelial cells health and number.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age over 18 y/o.
. Patients with well established Open Angle Glaucoma including Primary open angle glaucoma, Pseudoexfoliation or Pigmentary Glaucoma \& Steroid induced Glaucoma requiring incisional surgery for Intraocular pressure higher than target, despite receiving maximal tolerable medical treatment or were intolerant to medications with progressive glaucoma related visual field defects or optic nerve changes.
. Any of a above who needs cataract surgery
. In those specular microscopy can be performed without any delay in their treatment.
. Decision makers able to give informed consent.
Exclusion criteria
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.