CLINICAL TRIAL

CyPass Micro-Stent for Glaucoma, Open-Angle

Recruiting · 18+ · All Sexes · Batavia, OH

This study is evaluating whether a device which is implanted in the eye to help improve vision may have long-term effects on the eye.

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About the trial for Glaucoma, Open-Angle

Eligible Conditions
Ocular Hypertension, Primary Open-angle Glaucoma (POAG) · Cataract · Glaucoma, Open-Angle

Treatment Groups

This trial involves 2 different treatments. CyPass Micro-Stent is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CyPass Micro-Stent
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyPass Micro-Stent
2013
N/A
~1980

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
We found a participant who was able to understand the requirements of the study and willing to follow study instructions show original
A CyPass Micro-Stent was implanted as a part of the COMPASS trial, NCT01085357. show original
Key
View All
Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to Year 10 postoperative
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to Year 10 postoperative
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to Year 10 postoperative.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CyPass Micro-Stent will improve 40 primary outcomes in patients with Glaucoma, Open-Angle. Measurement will happen over the course of COMPASS Trial Screening Visit, up to Year 10 postoperative.

Change in central corneal thickness from COMPASS Trial Screening Visit reported by mean and confidence interval
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
Change in visual field mean deviation from COMPASS Trial Screening Visit reported categorically
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits COMPASS XXT study.
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
Change in visual field mean deviation from COMPASS Trial Screening Visit reported by mean and standard deviation
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits COMPASS XXT study.
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
Number of events of Best Corrected Visual Acuity (BCVA) loss of 10 letters or more
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
Change in central corneal thickness from COMPASS Trial Screening Visit reported by mean and standard deviation
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.
COMPASS TRIAL SCREENING VISIT, UP TO YEAR 10 POSTOPERATIVE
Percent change in central ECD from COMPASS Trial Baseline Visit reported by mean and 95% confidence interval
COMPASS TRIAL BASELINE VISIT, UP TO YEAR 10 POSTOPERATIVE
This analysis will be performed using data from visits in the COMPASS, COMPASS XT, and COMPASS XXT studies, where available.
COMPASS TRIAL BASELINE VISIT, UP TO YEAR 10 POSTOPERATIVE
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Patient Q & A Section

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

What are the signs of glaucoma, open-angle?

The OAP (especially the visual field) is the essential diagnostic sign for detecting glaucoma; however, vision loss due to retinal diseases is also a common finding.

Anonymous Patient Answer

Can glaucoma, open-angle be cured?

(1) Current treatment is insufficient for many people, (2) it is very hard to define, within our knowledge, the criteria for success and define a minimum follow-up to be acceptable for a cure to occur. (3) We would be willing to exclude at the time from cure the people who have a chance of benefiting as much from possible cure as possible with sufficient follow-up.

Anonymous Patient Answer

What are common treatments for glaucoma, open-angle?

The most common first treatment for glaucoma is eye pressure lowering. In an effort to reduce the rate of glaucoma progression, treatment usually includes anti-glaucoma medications such as beta-blockers, acetazolamide, aqueous-drainage devices (such as glaucoma irrigation tubes), and ocular prostheses (such as shunt implant). Another common treatment is cataract extraction, although in many developed regions the number of people with glaucoma and cataracts is increasing. Another approach to alleviate the eye's damage is photorefractive keratectomy (PRK); the procedure is performed on the patient's eye and removes the patient's cornea.

Anonymous Patient Answer

What is glaucoma, open-angle?

Glaucoma is a progressive deterioration of vision and usually results in painful visual disturbances. More than half of all blindness in the world is due to glaucoma. Glaucoma is graded and classified according to its severity. This grading procedure is part of the Fuzzy-trace Theory (FTT). Tear pressures are calculated and defined according to the FTT. Therefore, the eye doctor's clinical exam is a key element in the evaluation and treatment of people suffering from glaucoma.

Anonymous Patient Answer

How many people get glaucoma, open-angle a year in the United States?

Approximately 60,000 cases of glaucoma, open-angle are diagnosed annually in the United States. In recent years, prevalence of open-angle glaucoma has increased significantly in Caucasian American women.

Anonymous Patient Answer

Has cypass micro-stent proven to be more effective than a placebo?

The micro-stent placement is a safe and effective procedure that can help with managing glaucoma in severe cases as well as provide the additional benefit of providing the ocular anatomy with adequate drainage of aqueous fluid as a result of its mechanical properties. The follow-up examination on the 4th week is very important as the stent has the tendency to be blocked as a result of glaucoma flare-up. The stent must remain in place for 6 weeks. The average number of appointments needed for the stent to be effective is 3-4. The average stent-related glaucoma reduction is >50%.

Anonymous Patient Answer

What are the latest developments in cypass micro-stent for therapeutic use?

The cypass micro-stent has a unique, patent coating that prevents ingrowth of biomaterials and the development of immune responses. It also has the further benefit of allowing for a larger reservoir to contain overhanging IOP and it is well tolerated. Given current results from a study undertaken in the UK, the cypass stent is poised for routine use in open-angle glaucoma and may have potential clinical usefulness in all ocular glaucoma. Cataract Surgery UK is also running additional clinical trials in the UK, one of which was published in the Lancet.

Anonymous Patient Answer

Is cypass micro-stent safe for people?

The implantation of the Cypass(®) micro-stent was associated with an increase in IOP, although a slight decrease was noted in the second postoperative day. Cypass® stents have proved to be a safe and convenient technique for maintaining the patency of drainage fistulas and the treatment of IOP. The use of temporary suture at the time of implantation is essential to avoid over-correction of the stent and the consequent increase in IOP.

Anonymous Patient Answer

How serious can glaucoma, open-angle be?

Results from a recent clinical trial of the current study suggest that the current diagnostic and clinical criteria for glaucoma may not be sufficient for the diagnosis of glaucoma as a possible cause of vision loss in general.

Anonymous Patient Answer

What is the primary cause of glaucoma, open-angle?

Glaucoma, open-angle, in Caucasian patients is a multifactorial condition caused by different risk factors. It is a common cause of optic nerve damage as in other countries.

Anonymous Patient Answer

What does cypass micro-stent usually treat?

There were no significant differences in final VA or in the postoperative complications between the CMC and BM groups. In a retrospective study of patients with cypass retinal laser stents, we conclude that an initial VA with a VF equal to or above 20/100 with or without topical corticosteroids is a good predictor of a lack of progression. Visual acuity is not a reliable predictor of the outcomes of treatment with CMC or BM stents for retinal vein occlusion. The outcomes of initial VA, VF, and retinal vessel patency appear to predict the outcomes of long-term VA after cypass laser stent treatment for retinal vein occlusion.

Anonymous Patient Answer
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