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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

Must not have

Aged less than 18

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable to understand and give consent for treatment.

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I have eye conditions not being studied in this 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration of inflammatory mediators in aqueous humor

Concentration of inflammatory mediators in tears

Correlation between tears and aqueous humor

Secondary study objectives

Change of visual acuity through time

Incidence of anterior structural changes

Incidence of posterior structural changes

+2 more

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.

0 / 10Eligibility criteria met