Cosopt

Migraine, Open-angle glaucoma, Migraine Disorders + 6 more

Treatment

20 Active Studies for Cosopt

What is Cosopt

Timolol

The Generic name of this drug

Treatment Summary

Dorzolamide is a medication used to treat eye conditions such as open-angle glaucoma and ocular hypertension. It works by blocking an enzyme that helps regulate the fluid pressure and ion balance in the eyes. Unlike oral carbonic anhydrase inhibitors, Dorzolamide has minimal effects on acid-base and electrolyte levels, as well as few systemic side effects. It was first released in 1995 and is available as both a stand-alone drug (Trusopt) and a combination drug with Timolol (Cosopt PF).

Timoptic

is the brand name

Cosopt Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Timoptic

Timolol

1978

167

Effectiveness

How Cosopt Affects Patients

Dorzolamide is a medication that lowers pressure in the eye. It is used to treat open-angle glaucoma or ocular hypertension. When combined with other eye medications, Dorzolamide can have a stronger effect on reducing pressure in the eye. This medicine usually starts working within two hours after it is used.

How Cosopt works in the body

Dorzolamide is used to treat ocular hypertension and glaucoma. It works by reducing the amount of fluid produced in the eye, which lowers the intraocular pressure. This drug specifically targets an enzyme called Carbonic Anhydrase II which helps produce bicarbonate ions in the ciliary process of the eye. By inhibiting this enzyme, Dorzolamide reduces sodium and fluid transport, resulting in less fluid and lower intraocular pressure. When intraocular pressure is reduced, it prevents blood flow restrictions and keeps the optic nerve from getting damaged, which would cause vision loss.

When to interrupt dosage

The suggested dosage of Cosopt is contingent upon the diagnosed condition, such as neodynium yttrium aluminum garnet laser posterior capsulotomy, Ocular Hypertension and Increased Intra Ocular Pressure (IOP). The dosage is a function of the administration method (e.g. Solution - Ophthalmic or Solution / drops) outlined in the table below.

Condition

Dosage

Administration

Migraine Disorders

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Open-angle glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Migraine

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

inadequate response to other therapeutic measures

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

insufficient response to beta-blockers

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

requiring adjunctive or replacement therapy

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Open Angle Glaucoma

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Ocular Hypertension

5.0 mg/mL, , 5.0 mg, 10.0 mg, 20.0 mg, 2.5 mg/mL, 6.8 mg/mL, 6.83 mg/mL, 2.56 mg/mL, 5.12 mg/mL, 0.5 %, 0.25 %, 3.4 mg/mL, 0.1 mg/mL

Ophthalmic, Solution - Ophthalmic, Solution, , Oral, Tablet - Oral, Tablet, Solution / drops - Ophthalmic, Solution / drops, Solution, gel forming, extended release, Solution, gel forming, extended release - Ophthalmic, Liquid, Liquid - Ophthalmic, Suspension / drops, Suspension / drops - Ophthalmic, Suspension - Ophthalmic, Solution, gel forming / drops, Solution, gel forming / drops - Ophthalmic, Suspension

Warnings

Cosopt Contraindications

Condition

Risk Level

Notes

Lung Diseases, Obstructive

Do Not Combine

Sinus Bradycardia

Do Not Combine

Shock, Cardiogenic

Do Not Combine

Atrioventricular Block

Do Not Combine

Asthma

Do Not Combine

Heart Failure

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Timolol may interact with Pulse Frequency

There are 20 known major drug interactions with Cosopt.

Common Cosopt Drug Interactions

Drug Name

Risk Level

Description

4-Bromo-2,5-dimethoxyphenethylamine

Major

The therapeutic efficacy of 4-Bromo-2,5-dimethoxyphenethylamine can be decreased when used in combination with Timolol.

4-Methoxyamphetamine

Major

The therapeutic efficacy of 4-Methoxyamphetamine can be decreased when used in combination with Timolol.

Abediterol

Major

Timolol may decrease the bronchodilatory activities of Abediterol.

Adrafinil

Major

The therapeutic efficacy of Adrafinil can be decreased when used in combination with Timolol.

Agrostis gigantea pollen

Major

The risk of a hypersensitivity reaction to Agrostis gigantea pollen is increased when it is combined with Timolol.

Cosopt Toxicity & Overdose Risk

The lowest toxic dose of dorzolamide in rats is 1927mg/kg and 1320mg/kg in mice, when taken orally. In the event of an overdose, patients may experience electrolyte imbalances, acidosis, and changes in the central nervous system. Appropriate care should be taken and the patient’s potassium and pH levels should be monitored.

image of a doctor in a lab doing drug, clinical research

Cosopt Novel Uses: Which Conditions Have a Clinical Trial Featuring Cosopt?

34 active clinical trials are currently underway to assess the potential of Cosopt in providing relief for Ocular Hypertension, Increased Intra Ocular Pressure (IOP) and Open Angle Glaucoma.

Condition

Clinical Trials

Trial Phases

Open-angle glaucoma

47 Actively Recruiting

Phase 2, Not Applicable, Phase 3, Phase 4, Early Phase 1, Phase 1

Open Angle Glaucoma

12 Actively Recruiting

Phase 3, Not Applicable, Phase 4, Phase 2

Ocular Hypertension

12 Actively Recruiting

Phase 3, Phase 1, Phase 2, Not Applicable, Phase 4

requiring adjunctive or replacement therapy

0 Actively Recruiting

inadequate response to other therapeutic measures

0 Actively Recruiting

Migraine Disorders

1 Actively Recruiting

Phase 3

Migraine

48 Actively Recruiting

Phase 4, Not Applicable, Phase 1, Phase 3, Phase 2, Early Phase 1

Glaucoma

0 Actively Recruiting

insufficient response to beta-blockers

0 Actively Recruiting

Cosopt Reviews: What are patients saying about Cosopt?

5

Patient Review

11/27/2009

Cosopt for Increased Pressure in the Eye

This medication was prescribed to me by my optometrist when my eye pressure readings suddenly skyrocketed. Within a week and a half, it had dropped back down to the normal range. I've been using it regularly since then with no issues.

5

Patient Review

4/6/2013

Cosopt for Increased Pressure in the Eye

I experienced some leg pain while taking this medication.

5

Patient Review

7/15/2014

Cosopt for Wide-Angle Glaucoma

The drops caused my eyes to burn.

5

Patient Review

1/16/2010

Cosopt for Increased Pressure in the Eye

I've been using this product for a few years now and have always been really pleased with the results.

4

Patient Review

1/20/2009

Cosopt for Increased Pressure in the Eye

Blurred vision is a very annoying side effect. I spent a lot of money on medical testing for tia's but I feel the blurred vision was from the medication.

3.7

Patient Review

11/23/2008

Cosopt for Wide-Angle Glaucoma

Although this product has helped lower my eye pressure, I have noticed that my eyesight has gotten worse since using it.

3.3

Patient Review

8/20/2011

Cosopt for Wide-Angle Glaucoma

I stopped using Cosorpt for a few days and my back pain improved, which leads me to believe that the medicine was causing the issue in the first place. I had been taking it for years without realizing the potential consequences.

3.3

Patient Review

2/11/2014

Cosopt for Wide-Angle Glaucoma

Xalatan did help lower my eye pressure, which was in the upper 20s, but after adding Cosopt per my doctor's orders, I've seen even better results. My pressure is now down to 18. The only side effects I've experienced are occasional and mild; they include a stinging sensation in my eyes for a few moments post-application as well as a bitter taste at the back of my throat.

3

Patient Review

11/17/2008

Cosopt for Wide-Angle Glaucoma

There are times when I really don't like using cosopt because the blurred vision is so bad. It seems to be worse when I'm physically active.

3

Patient Review

6/24/2022

Cosopt for Wide-Angle Glaucoma

The medication works well, but the plastic containers are garbage. Sometimes you get all the contents in the first eye and nothing is left for the second. The current lot that I have is impossible to twist off; I have to cut it off. I've requested that my doctor prescribe Cosopt in a different container, but he wants me to stick with Pf

3

Patient Review

5/26/2010

Cosopt for Increased Pressure in the Eye

I unfortunately had a really negative reaction to these eyedrops. I got migraines, intense eye pain, high blood pressure, and felt very confused.

3

Patient Review

1/17/2021

Cosopt for Increased Pressure in the Eye

I'm experiencing a lot of tearing and itching. Unfortunately, this is the second time I've had to use this medication and I'm having the same side effects.

2.7

Patient Review

1/6/2009

Cosopt for Increased Pressure in the Eye

The medication has been successful in reducing my pressure, but the side effect of blurred vision is tough to deal with.

2

Patient Review

4/5/2018

Cosopt for Increased Pressure in the Eye

The individual plastic packs are difficult to use. If you squeeze too hard all liquid comes in one drop; too soft the liquid gathers into one drop. Some vials had No liquid at all. The fear of losing out an application with each use is not worth the risk.

2

Patient Review

12/8/2007

Cosopt for Increased Pressure in the Eye

1.3

Patient Review

2/5/2019

Cosopt for Increased Pressure in the Eye

The container is not designed well. It's too hard to open, and sometimes the liquid squirts out when you try to twist off the top. Plus, it stings a lot when you put in the drops, which makes me feel faint. I don't know yet how well it works in terms of lowering my blood pressure readings. But based on the packaging alone, this medication is overpriced and not worth it.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about cosopt

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is Cosopt?

"COSOPT contains two different types of medicine: dorzolamide hydrochloride, an ophthalmic carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker."

Answered by AI

What are the side effects of cosopt PF eye drops?

"If you experience any of the following side effects, tell your doctor or pharmacist promptly: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, feeling as if something is in the eye, sensitivity of eyes to light, strange taste in the mouth, or headache."

Answered by AI

What is the generic name for Cosopt?

"Cosopt pairs the drug timolol with another medication, dorzolamide. Your doctor may prescribe this combination drug if timolol alone is not sufficiently treating your high eye pressure or glaucoma."

Answered by AI

What is Cosopt eye drops used for?

"COSOPT is a medication used to lower the pressure in the eye in the treatment of glaucoma. It is used when beta-blocker eyedrop medicine used alone is not adequate."

Answered by AI

Clinical Trials for Cosopt

Image of University Health Network/ Toronto Western Hospital in Toronto, Canada.

Biofeedback Training for Glaucoma

Any Age
All Sexes
Toronto, Canada

This randomized controlled clinical trial evaluates the efficacy of visual biofeedback training on visual function and quality of life in individuals with glaucoma. Glaucoma is a progressive optic neuropathy that can lead to irreversible vision loss, including impaired fixation stability, reduced retinal sensitivity, and decreased functional vision. Biofeedback training is a visual rehabilitation technique designed to help patients improve fixation stability and optimize use of remaining visual function by training eye movements toward retinal areas with better sensitivity. Seventy participants with glaucoma will be randomized to either a biofeedback training intervention group or a control group. Visual function outcomes, including fixation stability, retinal sensitivity, visual acuity, reading speed, contrast sensitivity, and quality of life, will be assessed at baseline and follow-up visits. This study aims to determine whether biofeedback training can improve visual function and quality of life in patients with glaucoma.

Recruiting
Has No Placebo

University Health Network/ Toronto Western Hospital

Image of University of Texas Medical Branch in Galveston, United States.

Middle Meningeal Artery Stimulation for Migraine

18 - 100
All Sexes
Galveston, TX

This study is testing a new way to help with migraine headaches. Researchers want to see if it's safe and doable to stimulate a blood vessel in the head (called the middle meningeal artery) with microcatheters and microwires. This has never been done before for migraines and is an investigational treatment that is not part of standard migraine treatment. This stimulation would happen just before giving the standard lidocaine treatment, which is already routinely used for migraines. The goal is to see whether this new step could help improve headache outcomes. Two FDA-cleared medical devices will be used, the Cadwell Cascade 32 PRO and the Cadwell Guardian IONM System, to perform the stimulation and monitoring. In this study, the Cascade 32 PRO will be used in a way that is not part of its usual approved purpose (this is called "off-label" use) to gently deliver electrical pulses through a microcatheter. The Cadwell Guardian IONM System will be used in its normal, FDAapproved way for continuous monitoring during stimulation.

Recruiting
Has No Placebo

University of Texas Medical Branch

Peter Kan, MD,MPH

Image of American University in Washington D.C., United States.

Dietary Intervention for Migraine

18 - 75
All Sexes
Washington D.C., United States

The goal of this clinical trial is to evaluate whether a low-glutamate diet can improve migraine symptoms in adults with migraine and to explore possible biological changes associated with dietary improvement. The study focuses on whether reducing dietary glutamate intake may influence processes involved in migraine, such as brain excitation, inflammation, and oxidative stress. The main questions this study aims to answer are: Does following a low-glutamate diet reduce the number of migraine days and the severity and duration of migraine attacks, and improve quality of life? Are improvements in migraine symptoms associated with changes in blood-based biological markers related to migraine activity? Researchers will compare participants assigned to the low-glutamate diet with participants assigned to a wait-list control group to evaluate differences in migraine outcomes and related biological measures. Participants will: Complete a baseline run-in period while tracking headaches using a daily migraine diary Either follow a low-glutamate dietary intervention or continue their usual diet as part of a wait-list control Complete standardized questionnaires related to migraine symptoms and quality of life Provide blood samples for laboratory analyses Undergo neuroimaging assessments (for a subset of participants)

Waitlist Available
Has No Placebo

American University

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Image of University of Waterloo, School of Optometry and Vision Science in Waterloo, Canada.

Brain Stimulation for Vision Impairment

18+
All Sexes
Waterloo, Canada

This pilot clinical trial evaluates whether non-invasive brain stimulation improves the orientation and mobility (O\&M) skills of individuals with constricted visual fields in both eyes. The study is composed of three visits. The first visit is meant to confirm eligibility by performing a few clinical tests. Eligible participants will then complete two additional visits, one in which the participants receive active stimulation, and one in which the participants receive placebo (sham) stimulation. Stimulation will be administered in a randomized, double-blind order. To evaluate improvement, various measures of O\&M performance will be assessed on a standardized obstacle course featuring static natural and artificial obstacles at defined intervals after the intervention. The investigators hypothesize that the application of brain stimulation to region of the brain responsible for visual processing will improve the orientation and mobility skills of individuals with binocular constricted visual fields immediately following stimulation, and the results will inform the design of a future, larger-scale study.

Waitlist Available
Device

University of Waterloo, School of Optometry and Vision Science

Benjamin Thompson, PhD

Image of Byers Eye Institute in Palo Alto, United States.

LLM-Based Education for Glaucoma

18+
All Sexes
Palo Alto, CA

The purpose of this study is to evaluate whether a large language model (LLM)-based audiovisual educational tool improves the test time and reliability of standard automated perimetry (SAP) using the SITA Standard 24-2 protocol in English-speaking glaucoma patients. Glaucoma is a disease that can lead to blindness if not properly monitored and treated. One of the most important tests for glaucoma is the visual field (VF) test, which checks how well a person can see in different directions. However, this test is difficult for many patients to perform correctly, especially if they don't fully understand how it works. Unreliable test results can lead to repeated visits, wasted time, and incorrect treatment decisions. This study is testing whether a computer-based educational tool, powered by artificial intelligence (AI), can help patients better understand the VF test before taking it. The study team want to see if this helps make the test results more reliable. The goal is to improve the quality of care while reducing the burden on patients and clinic staff. The LLMs will be used as an educational tool only, not for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

Waitlist Available
Has No Placebo

Byers Eye Institute

Robert T Chang, MD

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Image of Arizona State University in Phoenix, United States.

App-based Breathing Program for Migraine

18+
All Sexes
Phoenix, AZ

Migraine is one of the most common neurological disorders, characterized by recurrent headaches, sensitivity to light and movement, nausea, and autonomic dysregulation. Although mind-body interventions like biofeedback have shown their efficacy, they remain underutilized due to barriers such as transportation, time constraints, lack of awareness, stigma, and cost. A targeted approach to enhancing HRV is HRV biofeedback (HRVB), a technique using visual or auditory feedback to help people regulate HRV through slow-paced breathing and positive emotional regulation to promote ANS balance and emotional resilience. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraine. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraine, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.

Waitlist Available
Online Trial

Arizona State University

Image of The Royal Alexandra Hospital in Edmonton, Canada.

Graft Selection for Glaucoma Surgery

18 - 110
All Sexes
Edmonton, Canada

Glaucoma refers to a group of progressive optic neuropathies that lead to permanent vision loss. Glaucoma is the leading cause of irreversible blindness globally. In 2020, it was estimated to affect 76 million individuals worldwide, with projections indicating this number will rise to 111.8 million by 2040. In Canada, glaucoma affects an estimated 2.7-7.5% of individuals over the age of 50, contributing substantially to the national disease burden. This condition is linked to damage of the optic nerve due to elevated intraocular pressure (IOP; raised eye pressure), which results in the loss of retinal ganglion cells. Therefore, most of the treatments are guided towards reducing the IOP either via using laser, medications or surgery. Glaucoma surgery is typically reserved for cases where IOP remains uncontrolled while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. The goal of many glaucoma surgeries is to divert aqueous humor from the anterior chamber to the subconjunctival space, therefore reducing intraocular pressure. The device used for this purpose are the PRESERFLO™ MicroShunt (Glaukos Corporation, Laguna Hills, CA, USA) (the documents will interchangeably use terms "stent" and "shunt" to refer to these devices in the text below). The device is implanted using the ab externo approach to channel fluid from the anterior chamber to the subconjunctival/subtenon space. To reduce postoperative fibrosis and inhibit fibroblast activity that could obstruct flow and lead to device failure, 5-fluorouracil (5-FU) or mitomycin C (MMC) are administered. Additionally, a double-layered closure of conjunctiva and Tenon's is performed to minimize Tenon's migration and blockage of tenon the stents. Despite these measures, stent encapsulation and failure are still too common requiring revisions and bleb needling in 2-20% of cases within the first 12 months of follow-up. This project will involve a series of studies evaluating graft selection in PreserFlo MicroShunt implantation, focusing on donor sclera, cornea, and pericardium as patch graft materials. First, the investigators will conduct a prospective, randomized study comparing clinical outcomes between these graft types. Outcomes of interest will include surgical success rates, post-operative hypotony, tube erosion, conjunctival complications, infection, and overall device longevity. Donor sclera has long been used as a patch graft in glaucoma drainage device surgery and is associated with low erosion rates and reliable long-term results. Corneal tissue is increasingly used due to its transparency and availability through eye banks, with demonstrated safety in ocular surface reconstruction and tube coverage. Pericardium is another durable, biocompatible option, historically applied in both cardiovascular and ocular surgery, and has shown effectiveness as a patch graft in glaucoma drainage implants. This comparison will extend to both primary implantation and revision surgeries, recognizing the high clinical relevance of graft performance in complex cases. Building on these results, the investigators will then perform a cost-effectiveness analysis of graft strategies, incorporating surgical time, post-operative management, complication rates, and need for re-operation. An economic model will be developed to evaluate costs and resource utilization associated with each material, providing valuable data for policy and surgical decision-making. Finally, the investigators will conduct a patient-reported outcome (PRO) study to assess patient comfort and satisfaction with different grafts. Surveys will evaluate domains such as foreign body sensation, cosmesis, and overall satisfaction at key time points (immediate post-operative period, 1 week, 3 weeks, and 3 months). These results will highlight the patient perspective, an often underrepresented but critical factor in surgical innovation. Together, these studies will comprehensively assess graft selection from surgical, economic, and patient-centered perspectives, informing evidence-based practice in glaucoma care.

Waitlist Available
Has No Placebo

The Royal Alexandra Hospital

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