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LASIK technology avoids the following problems during quality laser eye surgery

The Sliding Suction Ring
Application of adequate suct

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

ion is essential for intraocular pressure upsurge and dissection of good quality corneal flaps. On occasion, the suction ring slides prior to t

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

Examples of combination products may in

he buildup of adequate vacuum and the flap is decentered from the pupillary axis. This is reported to happen more frequently with the Hansatome

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

microkeratome due to a slower rise in vacuum. Applying equal downwards pressure on the ring through its handle and at the base knob for about 3

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

seconds prior to initiating vacuum has minimized this problem.

On occasion, the initial vacuum results in a decentered ring with a large sl

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

Combination pro

ant requiring the surgeon to release the vacuum to reposition the ring. It is not uncommon to see the ring sliding back in the conjunctival groo

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

ve created by the initial suction. Decentering the ring in the opposite direction prior to activating suction may achieve good centration as the

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

vacuum level may be high enough by the time the ring slides close to the center to prevent further slide towards the initial groove.

Anoth

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

er approach is to change the ring size (e.g. from 8.5 to 9.5 mm), hence avoiding the chemotic conjunctiva. Some surgeons advocate applying Vaso

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

con-A (Alcon Laboratories, Fort Worth TX) allowing a decrease in conjunctival swelling prior to reattempting the procedure 30 minutes later. If

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

his does not resolve the conjunctival chemosis, further difficulties might be encountered and it is best delaying the surgery for another day

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

Following aspects would a

>

The Mid-Cut Jam
The suction ring has fit well, the keratome slides easily in place and the cut is proceeding smoothly until….it s

dd to the challenges in developing combination products:

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

tops half-way and does not respond to either forward or backwards pedal commands. This unpleasant situation can occur secondary to a mechanical

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

or electrical failure of the keratome. The main goal of the surgeon in that situation is to protect the flap and the bed from the keratome blade

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

. Although resuming forward movement may result in an uneven cut, we have not encountered this in our experience.

A quick check of electrical w

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

iring may reveal a loose connection especially at the connection with the keratome motor. Every keratome should be handled differently in this s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ituation and the surgeon should inquire about the best approach to handle such a situation. For the Hansatome, if no movement can be initiated,

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

careful release of suction and sliding the keratome-suction ring as one unit backwards will ensure that the flap is not incarcerated under the b

.

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

lade.

The keratome head cannot be reversed along the track manually. On the other hand, with the Automated Corneal Shaper (ACS), releasing suct

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

Companies that provide selfless information through particip

ion might trap the flap under the footplate. It is therefore preferable to disassemble the keratome head from its base without releasing suction

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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