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Although this article is not directly related to LASIK, it offers an easy to understand definition regarding the various levels of visual efficiency. We all understand that to be told we have 20/20 vision is great; but exactly what do all those

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

other levels of vision mean? What's o.k., what's not o.k., what's bad? The following explanations should help clear up any confusion you might have.

20/20: This is considered good, standard normal vision.

20/25 to 20/65: Slightly subnormal vi

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ion, but not seriously impaired. Those below 20/45 will have some difficulty reading a newspaper at normal arms length, but most, upon holding it closer to their face, with good light, will still be able to read. It is still legal to drive in m

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ny states with visual acuity as low as 20/60. However, most drivers in this category will carry restricted licenses. Telescopic glasses qualify all of this group to drive so long as it is permitted in the state in which they are licensed, and if

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

they do not also have serious field vision loss.

20/70: Mildly impaired vision. It is at this point that people really begin to feel handicapped. Without magnification, reading newspapers is very difficult, and most states will not issue a dri

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ers license to persons with a visual acuity this low, unless they are equipped with telescopic glasses. Object and travel vision are still excellent, with the exception of those who have lost considerable field vision.

20/75 to 20/200: Moderate

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

y impaired vision. With the assistance of low vision aids, this group can still function as sighted in almost all circumstances. Object vision for this group is poorer, but is still adequate for nearly all activities. Examples; people with thi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

vision level will see the car clearly, but may not be able to identify its make and model. They can see that a person is coming, but may not recognize if it is a friend. Travel vision is acceptable, unless there is also field vision loss.

Rea

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ing poses the most difficulty for this group, but proper visual aids and training can eliminate this problem. People in this group should be equipped, and properly trained to read with the assistance of numerous available low-vision aids. For a

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

l members of this group driving is permitted with the use of telescopic glasses unless there is also serious peripheral-vision loss, or other limiting factors.

20/200 to 20/800: Seriously impaired vision. People in this group can read with the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ssistance of low-vision aids. Those below 20/500 might consider learning Braille. While this isn't mandatory, it is a viable option. Even with the use of telescopic glasses, people with this level of vision will not be able to drive. Object

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

vision is greatly diminished, but is still useful. Travel vision is adequate, however, those at the lowest end of the scale could sometimes trip over something as simple as a curb. Crossing streets can be quite hazardous for those at the lower

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nd of this scale due to the difficulty of seeing distant oncoming cars.

20/800 to 20/1200: Severely impaired vision. At this level of visual acuity a person loses an acceptable level of travel vision. People who have suffered a substantial los

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

of peripheral vision may find a white cane useful, or necessary even before this point is reached. At this stage of impaired vision, the use of the white cane becomes necessary, regardless of the cause of vision loss. It may be possible for so

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e in this group to read using very strong magnifiers, and large print publications. A +50 diopter lens will help most in this group to read textbook-size print.

20/1200 to 20/6000: Very severely impaired vision. A great many doctors refuse to

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ecognize the use of visual acuity figures this low. Letter sizes larger than 700 do not exist on eye test charts, but there are mathematical equivalents. Doctors describe vision at this level as the ability to see a hand moving one foot away, b

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

t without the ability to count fingers. People in the 20/1200 to 20/6000 group are dependent on at least the assistance of the white cane, or more probably, the need of a guide dog for independent mobility. A video visual aid for reading is the

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

only effective reading aid for this group. The best possible assistance available for reading is a Voice synthesizer that can convert print into speech.

This group has very little object vision, but as long as there is light perception, that vi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ion is useful. For example, a man walking down the street with his white cane sees two shadows ahead. He can also see light between the two objects. While he probably can't recognize the objects, he knows there is enough space between them for

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

im to pass through.

There you have it, a breakdown of the 7 levels of visual efficiency. I hope this will help you have a better understanding of just what those numbers mean at your next eye examination.

Copyright ©2006 Carl DiNello

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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E-Articles - The 7 Levels Of Visual Efficiency

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