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E-Articles - LASIK - Frequently Asked Questions, What You Need to Know Before Surgery
In our office, one of the most frequently asked questions is "So Doc, am I a candidate for laser vision correction?". Our answers below are not a substitute for a consultation with your eye doctor, however, the more you know the easier it is to make an informed decision.
Is Las
Is Las
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
er Vision Correction safe?
The FDA has determined that Laser Vision Correction is a safe and effective means of treating myopia, hyperopia or astigmatism. It is, however, not without risks or potential complications.
What Are The Long-Term Effects Of LASIK?
Excimer la
The FDA has determined that Laser Vision Correction is a safe and effective means of treating myopia, hyperopia or astigmatism. It is, however, not without risks or potential complications.
What Are The Long-Term Effects Of LASIK?
Excimer la
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
er procedures have been prevalent in many countries around the world since the late 1980's. Many clinical studies have investigated the long-term effects (15 years) of the Excimer laser on the cornea. All of these studies, without exception, have failed to demonstrate any long-term negative effect
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
on the integrity of the eye. Patients who require an enhancement procedure or develop a complication will typically do so within the first few months following the procedure, not years later.
It is essential that a patient considering a refractive surgery understand as much as possible about the
It is essential that a patient considering a refractive surgery understand as much as possible about the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
risks associated with the Excimer laser procedure. The Excimer laser procedure, like all surgical procedures, has limitations and risks. However, the risk of having a serious vision-threatening complication with LASIK is less than 1%.
Will I Have Perfect Vision After The Procedure? Wil
Will I Have Perfect Vision After The Procedure? Wil
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
I Still Need My Glasses?
Experience has shown us that Laser Vision Correction has been overwhelmingly successful in significantly reducing nearsightedness (myopia), farsightedness (hyperopia), and astigmatism. While vision improves significantly following the procedure, the degree of im
Experience has shown us that Laser Vision Correction has been overwhelmingly successful in significantly reducing nearsightedness (myopia), farsightedness (hyperopia), and astigmatism. While vision improves significantly following the procedure, the degree of im
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
rovement may vary from individual to individual. Overall, studies have shown that 98% of patients achieve 20/40 vision or better after one procedure (i.e. before any enhancements) which means they can drive legally, enjoy sports, and join the police or fire departments, all without their glasses.
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
Does The Procedure Hurt?
No, the procedure is painless, however, some people notice a sensation of pressure.
After the procedure, most patients experience only some irritation (usually reported as a burning sensation), light sensitivity, and watering of their eyes for a day or
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
wo.
Can Anyone Have LASIK? Am I A Candidate?
LASIK and PRK will not work for everyone, however, most nearsighted patients are candidates as well as many patients with astigmatism and/or farsightedness. An evaluation for refractive surgery should include counseling as to the ris
Can Anyone Have LASIK? Am I A Candidate?
LASIK and PRK will not work for everyone, however, most nearsighted patients are candidates as well as many patients with astigmatism and/or farsightedness. An evaluation for refractive surgery should include counseling as to the ris
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
s and benefits of the procedure as well as a presentation of alternative options. Some of the criteria used to determine if a patient is a candidate for refractive surgery includes their prescription, corneal thickness, post surgical expectations of visual acuity, occupation and contraindicating
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ocular and medical conditions.
Patients over 40 often hope that LASIK will allow them to see clearly at both near and far without reading glasses (like when they were 30). In most cases this is not possible. Typically a patient over 40 will need reading glasses when their eyes are corrected for
Patients over 40 often hope that LASIK will allow them to see clearly at both near and far without reading glasses (like when they were 30). In most cases this is not possible. Typically a patient over 40 will need reading glasses when their eyes are corrected for
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
distance regardless of whether that correction is achieved via contacts or refractive surgery. Most patients are familiar with monovision (one eye corrected for distance and one eye corrected for near), however monovision is usually best achieved through contact lenses, not refractive surgery.
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
strong>Does Insurance Cover The Costs Of Laser Vision Correction?
Typically, very few insurance companies will cover the cost of refractive surgery. Insurance companies usually look at refractive surgery as an elective procedure. Many employers have "flex accounts" or cafeteria
Typically, very few insurance companies will cover the cost of refractive surgery. Insurance companies usually look at refractive surgery as an elective procedure. Many employers have "flex accounts" or cafeteria
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
plans for unreimbursed medical expenses. Flex plans cover laser vision correction as a reimbursable expense.
Can I Wear My Contact Lenses Before The Procedure?
The use of contact lenses directly affects the shape and hydration of the cornea. Therefore, it is necessary to remove
Can I Wear My Contact Lenses Before The Procedure?
The use of contact lenses directly affects the shape and hydration of the cornea. Therefore, it is necessary to remove
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
contact lenses prior to both the pre-operative eye exam and prior to surgery.
Soft contact lens wearers should remove their contacts one to two weeks prior to both the pre-operative exam and surgery.
Rigid contact lenses (gas permeable and standard hard lenses) should be removed for approximate
Soft contact lens wearers should remove their contacts one to two weeks prior to both the pre-operative exam and surgery.
Rigid contact lenses (gas permeable and standard hard lenses) should be removed for approximate
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
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
y four to six weeks (or until your eye doctor says that your refractive error is stable) prior to both the pre-operative examination and surgery. Many patients are reluctant to wear glasses for this period of time, therefore, we can usually fit patients with soft contact lenses to help with the tr
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
nsition.
What Is Presbyopia? (Or, Why Do I Need Reading Glasses Or Bifocals?)
As we mature, the crystalline lens of the eye loses its elasticity, thus reducing our ability to focus on near objects. You will notice this as your "arms get too short". This change
What Is Presbyopia? (Or, Why Do I Need Reading Glasses Or Bifocals?)
As we mature, the crystalline lens of the eye loses its elasticity, thus reducing our ability to focus on near objects. You will notice this as your "arms get too short". This change
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
is called presbyopia, meaning that a different correction is needed for close work than for distance vision. Presbyopia usually occurs in the early to mid-forties. Laser vision surgery will not affect the progression of presbyopia, however, it will change how one copes with it. Typically a nears
.
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
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
ghted person can remove their glasses to see up close. After refractive surgery, they will no longer be nearsighted, thus they will not be able to remove their glasses to read.
Patients in their forties or older will most likely require reading glasses after refractive surgery. The need for read
Patients in their forties or older will most likely require reading glasses after refractive surgery. The need for read
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ng glasses would be necessary regardless of whether they have laser vision correction surgery.
Laser vision correction is one of the many options available to patients wishing to correct their vision. A consultation with an eye doctor will give an unbiased opinion as to the many options availabl
Laser vision correction is one of the many options available to patients wishing to correct their vision. A consultation with an eye doctor will give an unbiased opinion as to the many options availabl
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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