Risks & Complications

The risks of Femtolasik surgery

We wish to openly explain the risks associated with refractive error surgery, even if their appearance is very rare these days. The FemtoLasik method has further reduced the risks associated with laser operations, which were already rare. These days it’s fair to say that with FemtoLasik laser surgery, getting rid of spectacles is a very safe procedure.

Dry eyes

Dry eye is a common side effect in post -operative stage. For this reason, it is recommended that lubricating eye drops are applied to the operated eyes for a three- to six-month period. Most patients report, however, that they no longer need these eye drops for more than a month or two after surgery. Very few patients will need to put these drops for a longer period of time.

Decreased night vision

The risk of decreased night vision is extremely small and nowadays it is rarely documented to advancement in technology.

Over- and under-correction

Laser surgery-related side effects may be over- and under-correction. Over-correction means that in correcting the vision we go from minus to the plus side, which nevertheless generally evens out with time.

Sensitivity to light

Sensitivity to light is quite a rare complaint nowadays. It may be said that from two to six hours after surgery, the eye will be recovered from the procedure.

Protrusion of the cornea (keratoconus)

In FemtoLasik surgery, the very thin and uniform flap produced by the femtosecond laser has enabled the correction of increasingly larger refractive errors in a completely safe manner. Due to these factors, the risk of corneal protuberance has been limited to the minimum when using the FemtoLasik procedure. Due to the current technology, the risk is, as a consequence, practically non-existent. The more precise preliminary examinations have also raised safety to a whole new level – and have already enabled the detection of keratoconus at an early stage.

Retinal damage

In the FemtoLasik method, eye pressure does not need to be raised to a high level. For this reason, damage to the retina is very rare indeed.

Growing epithelium under the flap

About one month after the operation, there is an additional check to see if an epithelium – i.e. surface layer on the eye – has grown under the flap. The removal of an epithelium has to be performed these days to fewer than one in one thousand of those operated.

Incomplete flap

The femtosecond laser utilized by the FemtoLasik method has brought improved the safety aspect to a whole new level in this area as well. If for some reason the flap is made in an incomplete manner, a new one can be made immediately.

Infections

The speed of the FemtoLasik procedure has minimized the risk of infection. The flap made in the eye with a femtosecond laser is open for a very short time, thereby reducing the risk of infection. The quick procedure and highly developed equipment maintenance ensure an infection-free zone for the FemtoLasik operation.

Haze

Corneal haze tends to be caused by an aggressive wound response after surface ablation or Femolasik. In response to the “wound” of laser vision correction surgery ablation, the cornea can become clouded with white cells. Treatment is usually effective, however in very rare instances the cornea will remain scarred.

Technical supervision

In order to avoid mistakes, a licensed machine operator is present during the operation who monitors the laser technique and related equipment, ensuring that the mathematical values measured from the patient during the preliminary exam are correctly inputted into the laser’s computer. The machine operator operates and supervises the devices, thereby allowing the surgeon to personally concentrate on the operation and patient. Before surgery, the surgeon and machine operator further confirm together the values inputted.

The Risks for PRK

Dry eyes

Dry eye is a common side effect in post -operative stage. For this reason, it is recommended that lubricating eye drops are applied to the operated eyes for a three- to six-month period. Most patients report, however, that they no longer need these eye drops for more than a month or two after surgery. Very few patients will need to put these drops for a longer period of time.

Sensitivity to light

Sensitivity to light may take a few days to resolve. Usually wearing sunglasses help and it is recommended that in the first 5 days after the procedure, sunglasses are worn even inside.

Over- and under-correction

Laser surgery-related side effects may be over- and under-correction. Over-correction means that in correcting the vision we go from minus to the plus side, which nevertheless generally evens out with time.

Infections

Infections are extremely rare, and the risk is increased during the first 5 days of the surgery when the eye has the bandage contact lens in. Practicing hand hygiene greatly reduces the risk of infections and also storing the eye drops in a clean place.

Regression of refraction

Moderate regression may occur. This occurs mostly in myopic patients who have more than 6.0 diopters of refractive error and virtually all hyperopic patients.

After excimer laser assisted refractive surgery the cornea tends to regress back toward the original refractive error. The epithelium and the deeper stroma can reshape and reform at different rates and can cause regression.

For myopic patients, regression usually occurs within the first one to three months after surgery. Hyperopic patients may experience regression for a longer period of time. In all cases, it is reasonable to expect regression to stop within the normal six month healing period.

Regression that is severe or continues to progress may be a sign of ectasia.

Ectasia

This is an extremely rare condition where the cornea bulges out reversing the intended flattening effect of the treatment, or it can lead to progressive corneal deformity with thinning and increasing curvature changes, and the cornea can develop an irregular shape. The progressive corneal deformation is called ectasia, sometime requiring collagen cross linkage or corneal transplant.

This complication may occur in 1 out of 10,000 cases.

Haze

Corneal haze tends to be caused by an aggressive wound response after surface ablation or Femolasik. In response to the “wound” of laser vision correction surgery ablation, the cornea can become clouded with white cells. Treatment is usually effective, however in very rare instances the cornea will remain scarred.

The risks for SMILE

Like any surgical procedure, SMILE involves risk of unsuccessful results, complications or serious injury, from unknown and unforeseen causes.

Although the vast majority of our patients experience a significant improvement in their vision, neither your surgeon, nor your optometrist, not the centre nor its staff, can promise or guarantee that the procedure will be 100% effective or make your vision better than it was before the procedure. During your pre-operative examination, the likely surgical efficacy outcome (e.g. the chances of you seeing well without glasses or contact lenses after one surgery) will be conveyed to you based on the level of your particular refractive error.

There is a small possibility that the procedure or a complication arising from the procedure could cause your vision to be blurred either temporarily or permanently, doubled, distorted, or have halos or other disturbances, and that these would NOT be correctable with glasses or contact lenses. In the event this should occur, your surgeon will discuss and offer you advise on further treatment, which may involve medications and/ or more surgery. If the outcome cannot be corrected by medications or external surface corneal surgery, the only way of restoring the vision may be a corneal transplant.

However, it is believed that with current techniques and technology, the combined risk of all causes of a corneal transplant being necessary is approximately one in 20,000 or less.

Halos and Starburst

With the all-new SMILE technique the treatment is well designed to reduce the incidence of halos and star bursts. However, some patients do not see clearly at night or dim light and may notice glare and star burst around the lights and illuminated objects after the procedure.

This may be a temporary phenomenon or rarely a permanent problem. This is more commonly seen in patients with high levels of short sightedness or long-sightedness and for patients with larger than average pupil size.

Equipment Malfunction

Rarely the equipment can fail to operate and can produce undesirable result. However our maintenance standards are equivalent to the best in the world and tested by German technology from Carl Zeiss. The instrument goes through a testing protocol before each surgery.

Under-or Over Correction

The all-new SMILE surgery corrects precise amount of tissue to correct the desired refractive power. However rarely under and over correction of results is possible and it may require retreatment or use of glasses or contact lens

Light Sensitivity and Fluctuating Vision

The smile technique reduces the chance of light sensitivity and fluctuation of vision in most cases by precise correction and removal of tissue. But rarely light sensitivity and fluctuation of vision is possible, which will stabilize in most cases by 1 to 4 weeks. In 1% of cases it may be permanent.

Dry Eyes

SMILE technique reduces the chance of dry eyes due to less chance of cutting the corneal nerve, since the corneal flap is not developed in this form of treatment.However, in some cases dry eyes is possible and it can be treated with eye lubricants or punctual occlusion.

Optical Imbalance

If the surgeon performs the procedure on each eye on different days, in the interim period the eyes may not be able to balance and focus properly until the procedure is performed on both eyes because there will be a power difference between the two eyes.

Regression

The cornea is a living tissue and once any part of it is removed to reshape the cornea and correct the refractive error, it can re-grow and thicken to compensate for the changes in the shape. Therefore some effect of the correction may decrease over time and patient may require either further treatment or correction using glasses or contact lens.

Corneal Ectasia

A certain amount of corneal tissue must remain after SMILE procedure. This is believed to relate to the long term stability of the cornea. In rare instances, less tissue is left and this may lead to bulging of the cornea thus reversing the intended flattening effect of the treatment, or it can lead to progressive corneal deformity with thinning and increasing curvature changes, and the cornea can develop an irregular shape. The progressive corneal deformation is called ectasia, sometime requiring collagen cross linking or corneal transplant.

This complication may occur in 1 out of 10,000 cases.

Diffuse Lamellar Keratitis (DLK)

1 in 500 patients experience a temporary inflammatory reaction beneath the corneal surface. This condition has been called “Sands of Sahara” or diffuse lamellar keratitis also known as “DLK”. The exact cause of this complication has not been identified, and is likely due to many different factors. Patients with DLK may not show any symptoms at all or may experience blurred vision and tearing, which can last from several days, up to several weeks, and which can delay the healing process.

DLK generally can be treated with topical and/or oral steroids, occasionally with possible need for surgical intervention (the surgeon irrigates beneath the corneal surface).

Some Rare Side Effects

Epithelial in-growth, vascular occlusion, Microscopic corneal surface irregularity, infection, haemorrhage, blockage and other unforeseen complications which may or may not be directly related to the surgical procedure, can occur rarely.

The risks for Presbyond

The main risks for Presbyond are the same as for Femtolasik, since the procedure is done in the same manner.

It is important for this type of treatment for one to understand the following:

All patients, at whatever age, need to be aware of the aging changes that will take place in their eyes eventually. Patients need to consider their long term visual needs very carefully, as increasing age brings compromises that must be understood and accepted.

Younger patients and some older patients may choose Balanced Laser Vision Correction to focus both eyes into the distance; this balanced distance vision may be chosen by younger patients who are not concerned yet about the effects of aging or by older patients whose distance visual demands are absolutely paramount and they do not want to wear spectacles to achieve this level of satisfaction. So consideration has to be taken to the patient’s lifesyle. Patients choosing balance laser vision correction will benefit from maximal distance acuity, their eyes focus will be balanced, allowing them maximal depth perception and best possible night vision. However these patients will be inconvenienced by the need for close work glasses with increasing age. If over the age of 45, they have chosen the compromise “Clarity over Convenience”.

Other patients will accept a subtle compromise in absolute binocular visual clarity and choose Presbyond Laser Blended Vision to allow maximal freedom from the burden of spectacles. These patients will have chosen “Convenience over absolute binocular Clarity”. They should be free from spectacles for most general day to day tasks. One eye dealing with distance vision quite acceptably and the other with intermediate and some close work acceptably.

It should be pointed out that patients choosing Presbyond Laser Blended Vision because they want maximum freedom from glasses as they age, always retain the option to wear spectacles (or a single contact lens) to balance their eyes and give maximal binocular acuity for specific tasks. For example some may still wear spectacles to maximise vision for night driving or for prolonged periods of intense close reading.

Following Presbyond correction, the near vision reading ability may still change after a few years and one might need to do an enhancement.

Enhancement payment protocols for Femtolaser, SMILE, Surface Ablation and Presbyond

If any enhancement is required within one year of undergoing any type if laser procedure, any retreatment will be free of charge

If a retreatment is required between year 1 and year 5, then 50 percent will be charged.

After 5 years, full fee.