MINIject™ Implant for Glaucoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vold Vision, Fayetteville, AR
Glaucoma+1 More
MINIject™ Implant - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a device can lower IOP in people with glaucoma.

See full description

Eligible Conditions

  • Glaucoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether MINIject™ Implant will improve 2 primary outcomes in patients with Glaucoma. Measurement will happen over the course of 24 months.

24 months
Intraocular pressure decrease
Intraocular pressure decrease (outcome 2)

Trial Safety

Trial Design

1 Treatment Group

Implant Group
1 of 1
Experimental Treatment

This trial requires 975 total participants across 1 different treatment group

This trial involves a single treatment. MINIject™ Implant 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.

Implant Group
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

Vold Vision - Fayetteville, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Males and females, 46 years of age or older
A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
Pseudophakic with prior uncomplicated cataract surgery
Key

Patient Q&A Section

What causes glaucoma?

"A wide variety of medical and environmental factors are involved in the development of glaucoma. The high prevalence of open angle glaucoma is due to the increased resistance of the scleral outflow facility, as caused by a chronic elevation in intraocular pressure. Other factors seem to be the main reason for the increased risk of angle closure and its complications." - Anonymous Online Contributor

Unverified Answer

Can glaucoma be cured?

"There is considerable variability in the ability to prevent the loss of visual acuity from glaucoma. Further research is needed to develop clinical methods to identify which individuals are likely to have good vision at a reasonable risk." - Anonymous Online Contributor

Unverified Answer

What is glaucoma?

"Recent findings provides evidence that glaucoma is an age-related chronic degenerative optic neuropathy characterized by a slow or gradual progression of visual field loss. The term glaucoma is a misnomer as it is a disease that is not exclusive to the eye, but also encompasses many eye and inner ear symptoms." - Anonymous Online Contributor

Unverified Answer

What are the signs of glaucoma?

"Glaucoma can produce a variety of signs and symptoms such as visual field loss. Many tests can demonstrate if a damage is present or not. Some signs in those affected by glaucoma can be the same as the symptoms. These can include sudden vision loss, pain in the eye, tearing, a red eye, light sensitivity etc.\n" - Anonymous Online Contributor

Unverified Answer

How many people get glaucoma a year in the United States?

"The American Academy of Otolaryngology-Head and Neck Surgery estimates that 1 million Americans will be diagnosed with glaucoma a year by 2025, an increase of almost 60% since 2010." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glaucoma?

"A variety of glaucoma surgeries can be performed, which may restore vision or may be a palliative measure only. Glaucoma medication is necessary for symptomatic care of patients with glaucoma." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving miniject™ implant?

"The current study has found a statistically significant difference in IOP values when miniject™ implant was used (P= 0.001), but the IOP values did not fall significantly in comparison to the controls (P=0.3). In our study, there was no statistically significant difference in the number of antiglaucoma medications between the groups. Results from a recent paper show that miniject™ implant can be helpful in the treatment of glaucoma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of glaucoma?

"This article describes how to categorize the risk factors affecting glaucoma by the underlying cause. The various causes of glaucoma are often concurrent. For example, the prevalence of glaucoma is higher in people with refractive error, ocular hypertension, and diabetes, but the underlying mechanism(s) are multifactorial. Other causes include exposure to neurotoxins and UV radiation, as well as genetic factors that predispose to a particular form of glaucoma." - Anonymous Online Contributor

Unverified Answer

Is miniject™ implant typically used in combination with any other treatments?

"Mini-injection injection can be used to treat open angle glaucoma without altering medication compliance or requiring a change of injection site (i.e. subconjunctival glaucoma). Additional options include IOP reduction with topical medications, filtering surgery, and trabeculectomy. Mini-injection may be useful with certain medications that may cause toxicity or contraindication to regular application (e.g. beta blockers, sympathomimetics). There is currently insufficient evidence to support the use of multiple minipumps to achieve comparable IOP lowering efficacy or decrease patient morbidity." - Anonymous Online Contributor

Unverified Answer

What is the latest research for glaucoma?

"There are many different research areas and there are a few which do appear, along with many others which do not, to have potential impacts over the short to long term. Some of these areas have been studied a great deal and are well-received or receive a lot of attention. Others are more recently being looked at - there is much more research being done and the possible benefits are as yet unclear. Research into different medications has been shown to have some benefits and has led to a number of compounds. There is considerable information about the adverse and long-term effects of conventional glaucoma medication. There has certainly been an increase in knowledge regarding glaucoma over the last few years and one may expect further advances over time." - Anonymous Online Contributor

Unverified Answer

How serious can glaucoma be?

"Glaucoma is a serious condition. The damage that the disease causes is irreversible and it is important that patients are aware of the severity of their glaucoma when they are first seen for diagnosis. Many people with severe glaucoma will be disabled or lost sight by the time of diagnosis." - Anonymous Online Contributor

Unverified Answer

Is miniject™ implant safe for people?

"It may be reasonable, particularly for elderly patients who did not have cataracts at the time of the SLT, to use the Miniject™ Implant without lens accommodation. This approach is also a safe way of avoiding corneal damage during the surgery." - Anonymous Online Contributor

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