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Biomarker Sampling for Glaucoma Detection (AH-Tears Trial)
N/A
Recruiting
Led By Younes Agoumi, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group 1 : have no glaucoma and no systemic diseases
Presence of ocular disease specified for each group
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months
Awards & highlights
AH-Tears Trial Summary
This trial will test whether biomarkers in a patient's tears and aqueous humor can be used to detect early glaucomatous changes in order to better target treatment strategies and minimize vision loss.
Who is the study for?
This trial is for adults over 18 who can be monitored throughout the study. It's suitable for those needing corneal transplants, with or without glaucoma, and those requiring glaucoma surgery, with prior corneal transplants. Participants must have specific eye conditions and give informed consent. Those under 18 or unable to consent, or with other eye diseases are excluded.Check my eligibility
What is being tested?
The study investigates if certain inflammatory substances in the fluid (aqueous humor) inside the eye and tears can predict glaucoma after a corneal transplant. Researchers will collect samples of this fluid and tears from participants to identify potential biomarkers.See study design
What are the potential side effects?
Since this trial involves sampling bodily fluids rather than testing a drug or device, traditional side effects aren't expected. However, there may be minimal risks associated with collecting these samples such as discomfort or infection.
AH-Tears Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have glaucoma or any systemic diseases.
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I have the eye condition specified for my group.
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I need glaucoma surgery and have not had a corneal transplant.
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I need eye surgery after a previous corneal transplant.
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I need glaucoma surgery and have had a corneal transplant before.
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I need a corneal transplant, with or without having glaucoma.
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I am 18 years old or older.
AH-Tears Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of inflammatory mediators in aqueous humor
Concentration of inflammatory mediators in tears
Correlation between tears and aqueous humor
Secondary outcome measures
Change of visual acuity through time
Incidence of anterior structural changes
Incidence of posterior structural changes
+2 moreAH-Tears Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Intraocular surgery following corneal transplantationExperimental Treatment2 Interventions
Participants needing intraocular surgery (cataract, retina or glaucoma), with prior corneal transplantation (penetrating keratoplasty or Boston keratoprosthesis).
This allows analyzing samples during the potential development or progression of glaucoma in participants who have previously undergone corneal transplantation.
Group II: Glaucoma surgery following corneal transplantationExperimental Treatment2 Interventions
Participants needing glaucoma filtration surgery, with prior corneal transplantation (penetrating keratoplasty or Boston keratoprosthesis).
This allows analyzing samples once glaucoma is confirmed in participants who have previously undergone corneal transplantation.
Group III: Corneal transplantationExperimental Treatment2 Interventions
Participants needing corneal transplantation (penetrating keratoplasty or Boston keratoprosthesis), with or without glaucoma.
This allows analyzing samples at baseline (time 0), at the time of the corneal transplantation procedure.
Group IV: Cataract surgery onlyPlacebo Group2 Interventions
Participants needing cataract surgery, without glaucoma or any other corneal diseases.
Group V: Glaucoma surgery onlyPlacebo Group2 Interventions
Participants needing glaucoma filtration surgery, without any prior corneal transplantation.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,437 Total Patients Enrolled
7 Trials studying Glaucoma
270 Patients Enrolled for Glaucoma
Younes Agoumi, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Mona Harissi-Dagher, MDStudy DirectorCentre hospitalier de l'Université de Montréal (CHUM)
3 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Glaucoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You understand and agree to participate in the study after being provided with all the necessary information.I do not have glaucoma or any systemic diseases.I have the eye condition specified for my group.I need glaucoma surgery and have not had a corneal transplant.I need eye surgery after a previous corneal transplant.I am under 18 years old.I am unable to understand and give consent for treatment.I need glaucoma surgery and have had a corneal transplant before.I have eye conditions not being studied in this trial.I need a corneal transplant, with or without having glaucoma.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cataract surgery only
- Group 2: Glaucoma surgery only
- Group 3: Intraocular surgery following corneal transplantation
- Group 4: Corneal transplantation
- Group 5: Glaucoma surgery following corneal transplantation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives are being sought through this research endeavor?
"This trial is aiming to establish a correlation between tears and the equivalent liquid in the eye. Secondary objectives include measuring visual field loss, intraocular pressure, and posterior structural changes with automated Humphrey 24-2 tests, Goldman tonometry, and spectral domain optical coherence tomography (SD-OCT) imaging respectively over a baseline period."
Answered by AI
How many individuals have been invited to participate in this clinical investigation?
"Affirmative. The clinicaltrial.gov website attests that this trial is currently searching for participants, having first been posted on May 11th 2020 and most recently updated on July 4th 2022. About 200 patients will be admitted from a single medical centre."
Answered by AI
Are there any open enrollment opportunities for this medical experiment?
"Data posted on clinicaltrials.gov indicates that this medical trial is ongoing, with its launch being reported as May 11th 2020 and the most recent update occuring July 4th 2022."
Answered by AI
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