In 2008, Optical Express, the largest provider of laser vision correction in Europe established an online interactive survey of patients who received LASIK or LASEK at Optical Express locations to evaluate the quality of care provided, how well patient expectations were met, and the level of patient satisfaction, according to the company.

At one month after surgery, 13,655 patients completed the survey. Of the respondents, 91 percent had undergone LASIK and 9 percent had undergone LASEK.

Treatments ranged from the correction of up to -11.63 diopters (D) of myopia to up to +6.00 D of hyperopia. The mean spherical equivalent of all laser vision correction procedures was -2.27 D of myopia.

Patients ranged in age from 18 to 71 years, with an average age of 39.4 years.

Laser vision correction survey: One-month results

Results of the surveys completed one month after surgery by this large group of patients revealed:

• 95 percent said they were either “very satisfied” (77.8 percent) or “satisfied” (17.2 percent) with their vision after laser vision correction.
• 74.7 percent said their vision was better than they expected it would be. (19.4 percent said it was equal to their expectations and 5.9 percent said it was worse than what they expected prior to surgery.)
• 82.8 percent said their vision ws better after laser vision correction than it was with glasses or contact lenses prior to surgery.
• 94.2 percent said laser vision correction had changed their life for the better.
• 96.5 percent said they would recommend laser vision correction procedures, such as LASIK, LASEK, Presby-LASIK and PRK eye surgery, to their friends and family.

Conclusions

The researchers concluded the results of the survey show modern laser vision correction surgery by a large corporate provider produces a high level of patient satisfaction.

Regarding limitations of the study, the researchers noted that only 43 percent of 31,979 patients who attended their one-month follow-up visit after LASIK or LASEK completed the online survey.

A comparison of patients who completed the survey and those that did not, however, found no differences in most-pre-operative characteristics.

The researchers said that although the differences between those who completed the survey and those who did not “are unlikely to have true clinical relevance,” it is possible that the patients who completed the survey were selectively more satisfied or less satisfied than those who did not.

SOURCE:  Satisfaction of 13,655 patients with laser vision correction at 1 month after surgery. Journal of Refractive Surgery. July 2009. (Supplement: Clinical Outcomes and Quality of Care in Refractive Surgery, sponsored by Optical Express.)

The results of the study were published in an educational supplement to the July 2009 issue of Journal of Refractive Surgery sponsored by Optical Express.

LASIK complications: Study design and methods

Data were gathered from the electronic records of 22,900 patients (42,143 eyes) who underwent wavefront-guided LASIK at Optical Express refractive surgery centers in 2008. Of this total, 17,713 patients (32,569 eyes) returned for their scheduled one-month post-operative visit, representing a follow-up rate of 77.3 percent.

All patients had low to moderate myopia with or without astigmatism prior to surgery. The mean spherical equivalent amount of pre-operative myopia was -2.97 diopters (range: -0.37 to -6.00 D).

The average age of the patients was 35.6 years (range: 18 to 69 years).

All LASIK procedures were performed using the STAR S4 IR excimer laser system (Abbott Medical Optics, Santa Ana, Calif.) using a wavefront-guided ablation profile (Advanced CustomVue, AMO). The procedures were performed by 30 LASIK surgeons at 40 Optical Express centers.

Method of flap creation was chosen by the patients after consultation with their doctor. More than 75 percent of patients chose to have flaps created with an IntraLase FS-60 femtosecond laser (AMO). The others chose to have their flaps created with a Moria Evo3 One Use-Plus microkeratome (Moria SA).

Optical Express is Europe’s largest provider of laser vision correction and operates refractive surgery centers in the United Kingdom, Ireland, the Netherlands, Germany, France, Croatia and the United States, according to the company.

Intra-operative LASIK complications

LASIK complications were categorized as either intra-operative (occurring during surgery) or post-operative (occurring some time after surgery).

Of 42,143 nearsighted eyes undergoing wavefront-guided LASIK, the following intra-operative complications were noted:

• Flap creation complications: 22 eyes (1 in 1,916)
• Incorrect treatment: 2 eyes (1 in 21,072)
• Decentered laser ablation: 1 eye (1 in 42,143)

The total number of intra-operative LASIK complications was 25 (0.06 percent).

The most frequent of these complications were related to flap creation and included corneal abrasions, incomplete flaps, buttonhole flaps and “free caps” (a flap without an intact hinge to keep it attached to the cornea).

Flap-related complications appeared to be significantly more common in eyes for which flaps were created with a microkeratome rather than a femtosecond laser, the researchers said.

LASIK complications at one month

Among the 17,713 patients (32,569 eyes) who returned for their scheduled one-month post-operative visit, the following post-operative LASIK complications were noted:

• Dry eyes: 58 eyes (1 in 562)
• Mild diffuse lamellar keratitis (DLK): 58 eyes (1 in 562)
• Glare or halos: 19 eyes (1 in 1,714)
• Flap striae (microscopic folds): 13 eyes (1 in 2,505)
• Delayed healing: 9 eyes (1 in 3,619)
• Moderate or severe DLK: 8 eyes (1 in 4,071)
• Corneal infiltrates: 8 eyes (1 in 4,071)
• Astigmatism greater than 2.00 D: 7 eyes (1 in 4,653)
• Transient light sensitivity: 6 eyes (1 in 5,428)
• Microbial keratitis: 6 eyes (1 in 5,428)
• Significant haze: 5 eyes (1 in 6,514)
• Elevated intraocular pressure (IOP): 4 eyes (1 in 8,142)

Other post-operative complications included: recurrent corneal erosions (3 eyes), epithelial ingrowth (2 eyes), lens changes (2 eyes), corneal ectasia (1 eye) and retinal detachment (1 eye).

The researchers noted that many of the post-operative complications were transient and resolved over time.

Conclusions

The researchers concluded that wavefront-guided LASIK is a safe and effective procedure for the correction of low to moderate myopia and produces a very low rate of complications.

They caution, however, that a limitation of their study is that a large number of patients (22.7 percent) did not attend their scheduled one-month follow-up visit.

Therefore, the actual post-operative LASIK complication rates for the entire cohort of 22,900 patients (42,143 eyes) could be higher or lower than that noted for the 17,713 patients (32,569 eyes) from which these data were gathered.

If you would like to improve your vision through laser eye surgery, perform careful research before committing to any LASIK surgeon and/or procedure. Ask several doctors about the benefits and risks of various laser refractive procedures, such as LASIK, PRK and Presby-LASIK. In addition, inquire about LASIK eye surgery cost, possible insurance coverage and available financing plans.

SOURCE:  One-month outcomes of wavefront-guided LASIK for low to moderate myopia with the VISX STAR S4 laser in 32,569 eyes. Journal of Refractive Surgery. July 2009. (Supplement: Clinical Outcomes and Quality of Care in Refractive Surgery, sponsored by Optical Express.)

Toric intraocular lenses (IOLs) are specially designed lens implants that contain both sphere and cylinder powers to correct astigmatism. Use of toric IOLs may reduce the need for a secondary surgical procedure called limbal relaxing incisions (LRI) after refractive cataract surgery and RLE.

Toric IOL study: Design and methods

The study included 32 eyes of 19 consecutive patients that underwent RLE with implantation of the AcrySof Toric IOL (Alcon Laboratories). All eyes had more than 1.00 diopter (D) of corneal astigmatism prior to surgery.

Data gathered pre-operatively and six months after surgery included uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA) and refractive sphere and cylinder powers.

Patients also completed a questionnaire to evaluate their overall satisfaction, presence of visual phenomena and their level of spectacle independence after surgery.

Toric IOL study: Results

Results at six months following surgery included:

• 100 percent of eyes had UCVA of 20/32 or better.
• 84.3 percent of eyes had UCVA of 20/25 or better.
• 100 percent of eyes had BCVA of 20/25 or better.
• Mean refractive cylinder was reduced from -2.46 D pre-operatively to -0.53 D after surgery.
• 50 percent of eyes had no change in BCVA after surgery compared to pre-operative BCVA.
• Four eyes (12.5 percent) gained one line of BCVA and 11 eyes (34.4 percent) gained two or more lines of BCVA after surgery.
• One eye (3.1 percent) lost one line of BCVA after surgery.

All patients reported being satisfied with their vision following the RLE procedure, with none reporting significant visual phenomena.

Conclusions

The researchers concluded RLE with toric IOL implantation produced good visual and refractive outcomes for the correction of both spherical (nearsighted or farsighted) and cylindrical (astigmatism) refractive errors.

SOURCE:  Refractive lens exchange with foldable toric intraocular lens. American Journal of Ophthalmology. July 2009.

In the June 2009 issue of Optometric Management, optometrist Justin Holt, OD, updates his colleagues on the latest premium IOLs available for patients who need cataract surgery or who desire lens-based refractive surgery, such as refractive lens exchange (RLE) or phakic IOL implantation.

The blending of cataract and refractive surgery

According to Dr. Holt, today’s cataract patients are also refractive surgery patients: They typically want as much freedom from glasses as possible after surgery, with the least amount of visual side effects.

He says while there is no single “perfect” IOL, people today have more options in premium lens implants than ever before, and it’s up to eye doctors to help their patients choose the IOL that best suits their needs.

Among the choices available…

Aspheric IOLs

Aspheric IOLs change in shape from the center of the lens to the periphery, a feature that is designed to sharpen vision and reduce an optical defect called spherical aberration.

Aspheric IOLs produce sharper vision than conventional IOLs, especially in low light conditions, according to manufacturers of the lenses.

Most aspheric lenses are monofocal (single power) lenses, so reading glasses typically are still needed after surgery, unless the lenses are implanted in both eyes to create a monovision correction (one eye corrected for distance vision and the other eye for near).

Also, aspheric lenses do not correct astigmatism. So eyeglasses or a second surgical procedure, such as limbal relaxing incisions (LRI), LASIK, LASEK, Epi-LASIK or PRK may be needed after surgery for patients with pre-existing astigmatism.

Examples of aspheric IOLs include:

• AcrySof SN60WF (Alcon)
• SofPort Advanced Optics (Bausch & Lomb)
• Tecnis Z9000 (Abbott Medical Optics)

Toric IOLs

Toric IOLs are premium intraocular lenses that contain both a spherical power (to correct nearsightedness or farsightedness) and a cylindrical power, which makes one meridian of the lens more curved than any other, to correct astigmatism.

Computer-applied markings on toric IOLs allow cataract surgeons and refractive surgeons to rotate the lens into the proper position within the eye so it is aligned perfectly to correct corneal astigmatism.

Toric IOLs can correct mild and moderate pre-existing astigmatism without the need for LRI or additional refractive surgery. Reading glasses may still be needed after surgery, however, unless lenses are implanted in both eyes for monovision.

The AcrySof Toric IOL (Alcon) is an example of a toric intraocular lens.

Presbyopia-correcting IOLs

Presbyopia-correcting IOLs are premium intraocular lenses that reduce the need for reading glasses after cataract or refractive surgery.

There are two types of  IOLs that correct presbyopia: accommodating IOLs and multifocal IOLs.

Accommodating IOLs

Accommodating IOLs are monofocal intraocular lenses that have a flexible surrounding structure (the “haptic”) that allows the central portion of the lens (the “optic”) to move slightly forward within the eye in response to focusing effort, thereby improving near vision.

The Crystalens IOLs (Bausch & Lomb) currently are the only FDA-approved accommodating IOLs used in the United States.

Multifocal IOLs

Multifocal IOLs, like multifocal or bifocal contact lenses, contain more than one power to correct vision at multiple distances simultaneously.

While the multiple refracting zones of multifocal IOLs provide a wider range of vision than conventional monofocal IOLs, they also cause some light scatter, which initially may cause visual symptoms such as halos at night, Dr. Holt says.

As patients adapt to multifocal IOLs over a period of days to months, however, these symptoms typically become less bothersome and may disappear altogether.

Adaptation to multifocal IOLs is similar to adapting to the limitations of a monovision correction produced by monofocal IOLs or contact lenses, Dr. Holt says.

Examples of currently available multifocal IOLs include:

• AcrySof IQ ReSTOR (Alcon)
• ReZoom (Abbott Medical Optics)
• Tecnis Multifocal IOL (Abbott Medical Optics)

Phakic IOLs

Phakic IOLs are refractive intraocular lenses designed to be implanted without removal of the eye’s natural lens to correct large amounts of myopia.

Patients who opt for phakic IOLs typically are younger than age 45 and may not be good candidates for LASIK or other laser vision correction procedures.

Phakic IOLs can be implanted in front of the pupil (anterior chamber phakic IOLs) or behind it (posterior chamber phakic IOLs).

Anterior chamber phakic IOLs are attached to the front of the iris and are therefore somewhat visible. Posterior chamber phakic IOLs, on the other hand, are virtually invisible behind the pupil.

Desirable features of phakic IOLs include:

1. Because the natural lens is left intact, young patients retain their normal focusing ability and are not forced to wear reading glasses prematurely.
2. Phakic IOLs can be removed if cataract surgery becomes necessary later in the patient’s life.
3. In many cases, phakic IOLs can safely correct higher amounts of myopia than LASIK and other types of laser vision correction.

FDA-approved phakic IOLs include the Visian ICL, a posterior chamber phakic IOL manufactured by STAAR Surgical (Monrovia, Calif.) and the Verisyse Phakic IOL, an anterior chamber lens manufactured by Abbott Medical Optics (Santa Ana, Calif.).

Education and patient expectations are key

Dr. Holt advised his fellow eye doctors to appropriately screen and educate their patients about currently available premium IOLs.

A good understanding of the features, benefits and limitations of current IOL technology and having realistic post-operative expectations are key to patient satisfaction after surgery, he says.

SOURCE:  Understanding the latest IOL technology. Optometric Management. June 2009.

Of the 500 surgeons on the Panel, 31 responded to the survey.

Among the results:

• 72 percent of the respondents say they have modified their surgical approach to reduce LASIK risks, especially the risk of ectasia — a rare but serious LASIK complication that can cause permanently reduced vision.
• Approaches respondents are using to reduce the risk of ectasia include: paying more attention to pre-existing optical aberrations of the eye when screening LASIK candidates; using a more conservative criterion for minimum residual corneal thickness under the LASIK flap after surgery; creating thinner LASIK flaps with a femtosecond laser to preserve corneal thickness under the flap.
• Regarding laser vision correction preferences, 55 percent of the respondents prefer wavefront-guided LASIK, 20 percent prefer conventional LASIK and 15 percent prefer PRK.
• 73 percent of the LASIK surgeries performed by the respondents are custom LASIK procedures.
• The average LASIK cost charged by the respondents is $2,273 per eye.

If an enhancement surgery is needed to improve visual outcomes of LASIK, 82 percent of the respondents say they prefer to lift the original LASIK flap and the rest say they prefer to perform a surface ablation procedure such as PRK.

SOURCE:  National Panel reflects on refractive surgery. Review of Ophthalmology. July 2009.

Retreatments after LASIK and PRK: Study design

To determine the rate of retreatment and to identify risk factors for unacceptable outcomes requiring retreatment after wavefront-optimized LASIK and PRK, researchers at Emory University (Atlanta, Ga.) conducted a retrospective review of 855 eyes undergoing these treatments from January 2005 through December 2006.

Wavefront-optimized LASIK is a semi-customized laser vision correction procedure designed to control a specific type of optical error called spherical aberration (SA). It is believed SA is a major cause of glare, halos and other night vision disturbances after laser vision correction.

Wavefront-optimized procedures differ from wavefront-guided LASIK and PRK, which are fully customized laser procedures aimed at controlling many other higher-order aberrations in addition to SA.

All wavefront-optimized procedures evaluated in the study were performed by the same surgeon using the same proprietary excimer laser platform (Allegretto Wave, WaveLight AG). All LASIK flaps were created with an Amadeus I microkeratome (Abbott Medical Optics, Santa Ana, Calif.).

Prior to surgery, 785 of the eyes (92 percent) were nearsighted, 70 eyes (8 percent) were farsighted. Additionally, 231 eyes (27 percent) had at least 1.00 D of astigmatism and 61 eyes (7 percent) had at least 2.00 D of astigmatism.

Postoperative measurements included uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) at three months. The decision for re-treatment surgery was not made until at least three months after the initial procedure and refractive stability was confirmed.

Retreatments after LASIK and PRK: Study results

Analysis of the study data revealed the following results:

• After the initial wavefront-optimized LASIK and PRK treatments, 72 percent of eyes achieved UCVA of 20/20 or better and 99.5 percent of eyes achieved UCVA of 20/40 or better.
• A total of 54 eyes (6.3 percent) had enhancements performed to improve uncorrected visual acuity.
• There were no significant differences in re-treatment rates based on patient age or sex, refractive procedure performed (PRK versus LASIK), operating room temperature or humidity, or the month or season during which the primary procedure was performed.
• There was no correlation between degree of myopia and re-treatment rate.
• Eyes were significantly more likely to undergo LASIK or PRK enhancement surgery if they were farsighted rather than nearsighted (12.8 percent versus 6.0 percent) or had astigmatism equal to or greater than 1.00 D (9.1 percent versus 5.3 percent).

The researchers also noted that the study employed a relatively liberal re-treatment policy, and that only 15 eyes that had enhancements (27.8 percent) had UCVA worse than 20/40 after the initial LASIK or PRK procedure.

If the criteria for enhancement surgery was UCVA worse than 20/40 prior to re-treatment, the enhancement rate for the study would have been 1.7 percent.

The researchers concluded that the re-treatment rate for wavefront-optimized LASIK and PRK performed with the WaveLight Allegretto Wave excimer laser platform is low, and eyes that are at greatest risk for needing an enhancement after these procedures are those that are farsighted or have astigmatism equal to or greater than 1.00 D prior to surgery.

SOURCE:  Incidence, outcomes, and risk factors for retreatment after wavefront-optimized ablations with PRK and LASIK. Journal of Refractive Surgery. March 2009.

For the recent 2008 survey, 634 surgeons responded, representing 13 percent of the ASCRS membership.

Here are some of the highlights of the survey. (The results obtained from this group of respondents may not accurately reflect the preferences and opinions of other U.S. refractive surgeons.)

• The number of LASIK procedures declined to 759,000 in 2008, down from 856,000 the previous year (approximately 12 percent decrease).
• The number of PRK procedures increased to 229,000 in 2008, up from 160,000 the previous year (approximately 43 percent increase).
• The total number of laser vision correction procedures performed in 2008 was 988,000. This total is essentially the same as it was the previous two years.
• Only 21 percent of surgeons say they perform more than five LASIK cases per month.
• For treating high myopia (-10.00 D), 40 percent of surgeons responding sy they prefer phakic intraocular lens (IOL) implantation. The next largest group (24 percent) prefer “waiting” to performing surgery at this time, 20 percent say they prefer LASIK and 11 percent say they prefer PRK.
• For moderate hyperopia (+3.00 D), 46 percent of surgeons prefer LASIK and 25 percent prefer refractive lens exchange (RLE).
• For high hyperopia (+5.00 D), 54 percent of surgeons prefer RLE, 30 percent prefer waiting and 9 percent prefer LASIK.
• For lens-based surgical treatment for presbyopia, 43 percent of surgeons responding say they prefer monovison. But 32 percent say they prefer a multifocal IOL or an accommodating IOL to monovision.

The survey also found that an increasing number of LASIK surgeons say they are creating thinner corneal flaps and/or are increasing their minimum residual corneal thickness preferences to minimize the risk of corneal ectasia, a rare but one of the most serious LASIK complications.

SOURCE:  Survey proves flatlines aren’t always bad. Review of Ophthalmology. June 2009.