US FDA Approves First Implantable Miniature Telescope to Improve Sight in Patients Affected With Age-related macular degeneration(AMD)

Medical Device designed to help those with end-stage, age-related macular degeneration manufactured by VisionCare Ophthalmic Technologies Inc. of Saratoga, California.

The United States. Food and Drug Administration on 6 July 2010 published a pres release stating that they have approved a first of its kind Implantable Miniature Telescope (IMT) for helping patients affected with improve vision in some patients with end-stage age-related macular degeneration (AMD).
This Miniature Telescope can be surgically implanted in one eye, Miniature Telescope can replace the naturally occurring lens inside the eye ball Miniature Telescope provides an image with the two times magnification .
Age related macular degeneration (AMD), is a condition where it develops a loss of vision in the center of the visual field (the macula) due to damage over the retina, it develops a loss of vision at the center point of the visual field. This disease condition is related to aging and factors affecting degenerative processes due to aging are responsible for this disease, it generally affects older peoples..
Age related macular degeneration (AMD) affects older peoples so that they find it difficult to perform day today functions and also they find it difficult to recognize peoples.
This Implantable Miniature Telescope device will certainly improve the quality of life of many people
The IMT is has two models: one modle which can provide magnification of 2.2 times
And other model that provides magnification of 2.7 times.

The IMT is intended to magnify and project images onto a healthy portion of the retina. The IMT can be implanted surgically in only one eye; and the other eye is not implanted so as to get peripheral vision.
The IMT can be implanted in patients with stable severe to profound vision impairment (where vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) related to end-stage AMD. Such patients may show visually significant cataract.

Patients are required to agree and go through training with an external telescope before the actual implantation is done , to ascertain the if a sufficient amount of improvement in vision can be achieved with the external telescope , and to ascertain if the patient has sufficient enough peripheral vision in the other eye which will not be implanted. Patients are also required to agree to participate in a post-operative training.
A multi-center clinical trial was conducted on 219-patient for IMT devise, , about 90 % patients got as a minimum as a 2-line gain in distance or visual acuity,
75 % of patients showed improvement in the level of vision from severe or profound impairment to moderate impairment.

Untoward effects of IMT implantation

Due to the size of this devise IMT , implantation may cause profound loss of corneal endothelial cells (ECD), the layer of cells which keeps and maintain the clarity of the cornea, and

Chronic endothelial cell loss.

The chronic rate of endothelial cell loss can be about 5 percent per year.
Significant losses in corneal endothelial cells ECD may result in corneal edema, corneal decompensation, which requires corneal transplant. In the clinical study, about 10 eyes showed unresolved corneal edema, and five required corneal transplants.

The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

It is required that the risk factors of IMT implantation are adequately and regularly informed to patients, It is required that the “Acceptance of Risk and Informed Decision Agreement” should be completed by patients before the Implantable Miniature Telescope device IMT implantation surgery, the agreement contains a guide for patients and their doctors for educating about the risks related to Implantable Miniature Telescope device IMT implantation. Patients must be provided sufficient time to understand and evaluate and all of the information about IMT.
What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices – PMN or 510(k)

Antibiotic Definition and classification

Antibiotic resistance and Drug resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs


Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by design concept for pharmaceutical industry
3.Quality by design concept in pharmaceutical industry an  explanation

%d bloggers like this: