Implantable Miniature Telescope (IMT) for Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Eye Associates of New Mexico Vision Research Center, Albuquerque, NM
Macular Degeneration+1 More
Implantable Miniature Telescope (IMT) - Device
Eligibility
65+
All Sexes
Eligible conditions
Select

Study Summary

Telescope Exchange Study

See full description

Eligible Conditions

  • Macular Degeneration
  • Age-related Macular Degeneration

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Implantable Miniature Telescope (IMT) will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Macular Degeneration. Measurement will happen over the course of Subjects will be followed up for three years post implantation.

Subjects will be followed up for three years post implantation
Adverse events
Decrease in best corrected distance visual acuity (BCDVA)
Endothelial Cell Density
Increase in best corrected distance visual acuity (BCDVA)

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Implantable Miniature Telescope (IMT)
1 of 1
Experimental Treatment

This trial requires 75 total participants across 1 different treatment group

This trial involves a single treatment. Implantable Miniature Telescope (IMT) 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.

Implantable Miniature Telescope (IMT)
Device
Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: subjects will be followed up for three years post implantation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly subjects will be followed up for three years post implantation for reporting.

Closest Location

Eye Associates of New Mexico Vision Research Center - Albuquerque, NM

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I agree to undergo pre-surgery training with a low vision specialist in order to learn about how to manage my vision after surgery. show original
Improve the ETDRS chart by 5 letters or more using an external telescope. show original
I agree to participate in postoperative vision training with a low vision specialist. show original
A patient must be able to provide and sign a voluntary informed consent in order to be treated. show original
I have FA-confirmed retinal findings of geographic atrophy or disciform scar with foveal involvement. show original
Be age 65 or older
On the ETDRS chart, have BCDVA between 20/160 and 20/800 (inclusive). show original
Be pseudophakic in the eye selected for telescope implantation
following criteria: Patients must meet the following criteria: 1 show original

Patient Q&A Section

What is macular degeneration?

"Macular degeneration is a disease that can cause vision loss, painful blind spots, and decreased central vision. There are two types of macular degeneration, dry and wet. Dry macular degeneration is often seen when one has been diagnosed with age-related macular degeneration. Individuals who were not currently affected by dry age-related macular degeneration can eventually develop an advanced form of macular degeneration. Macular degeneration can be prevented in elderly people by eating a well balanced diet, regular exercise, and not smoking. Macular degeneration typically manifests itself after age 60 though it can manifest as early as age 40 or as late as age 90." - Anonymous Online Contributor

Unverified Answer

What are the signs of macular degeneration?

"In a group of patients presenting with similar clinical histories, the fundus appearance of AMD varies greatly. This is because the disease process is systemic and is not limited to the macula itself." - Anonymous Online Contributor

Unverified Answer

How many people get macular degeneration a year in the United States?

"The National Eye Institute reports that macular degeneration is the leading cause of vision loss and is the leading cause of blindness in the United States." - Anonymous Online Contributor

Unverified Answer

What are common treatments for macular degeneration?

"Some macular degenerations, particularly wet age-related macular degeneration, may be responsive to anti-VEGF injections. A number of other macular degeneration therapies are emerging that involve laser photocoagulation of the choroids and/or retinal pigment epithelium. A recent trial of dexamethasone intravitreal implant versus pegaptanib intravitreal implant in wet AMD suggests dexamethasone may be more beneficial. In terms of future treatments, the use of antisense therapy in exon- skipping with splice-modifying siRNA may one day be used in wet AMD." - Anonymous Online Contributor

Unverified Answer

What causes macular degeneration?

"The authors found that a number of potentially modifiable and potentially preventable causes, especially those related to outdoor air pollution and smoking, appear to be associated with AMD. Further study may allow targeting of groups who should be monitored for preventive activities." - Anonymous Online Contributor

Unverified Answer

Can macular degeneration be cured?

"No conclusive evidence exists that any intervention to delay or prevent the onset of age-related macular degeneration has been shown to have an effect comparable to the no treatment." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of implantable miniature telescope (imt)?

"The overall comfort rate was 85% in the group of patients with complete implantation. The complication rate was 1.7%. These were low and similar to previous series. There were no instances of any problems related to the instrumentation." - Anonymous Online Contributor

Unverified Answer

Is implantable miniature telescope (imt) typically used in combination with any other treatments?

"There are two different types of mini telescope in use: the conventional imaging telescope and the compact, mini, imaging telescope. There are some cases where a combined treatment that incorporates IMIT is used, especially when it is combined with other therapies." - Anonymous Online Contributor

Unverified Answer

Does implantable miniature telescope (imt) improve quality of life for those with macular degeneration?

"The IMT has shown positive results in several studies in those with noninfectious uveitis that have responded to topical ointment medication. It is currently available in India and is currently being tested in Nepal.  There is also a small body of anecdotal evidence that the IMT may be useful in those with diabetic macular edema.  It will be helpful to further test this approach.\nhttp://web.archive.org/web/20080219102231/http://www.dsu.edu/biology/research/health_care_in_india." - Anonymous Online Contributor

Unverified Answer

Has implantable miniature telescope (imt) proven to be more effective than a placebo?

"The effectiveness of an imt in patients with a high or average risk for MD was similar. There was no effect on retinal sensitivity. However, a larger study with more subjects and a longer follow up would be useful. An imt is a good therapy for patients with a high risk for new vascular age-related macular degeneration (AMD), however its effectiveness in patients with a low risk should be determined by a randomized, controlled trial to avoid excessive costs for patients who probably will not benefit." - Anonymous Online Contributor

Unverified Answer

Is implantable miniature telescope (imt) safe for people?

"The device provides clear images in both the near and distance environments, although not in the far sighted visual field. When the near and distance images were analysed together, it was possible to see that in almost all cases, near images appeared to coincide with distance images, and for a couple of people, it could be discerned that a small percentage of subjects benefited significantly over those with unimpaired near- vision. This is a positive report and shows that Imt is suitable for people. However, further research is needed into patients who may not benefit from implants." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets macular degeneration?

"About 50% of people with MacD may have macular atrophy before age 80 years old. It is recommended that most patients with age-related macular degeneration (AMD) should have an eye examination annually and a complete eye examination usually once a year. The exam should include measurements of the visual field and examination of the fundus and retina in good light. A detailed visual examination will help identify the signs and symptoms of AMD, as well as evaluate for other eye conditions." - 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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