Acuity
The Comprehensive Refractive Study (CRS)-USA LASIK Study of 1,800 eyes examined 754 eyes that were not treated for astigmatism. None lost two or more lines of BCVA. One hundred six of these patients reported having lost between one and two lines of vision at some point during the 3 months between the operation and the post-operative visit. Of the 106, 69 had regained BCVA by the third month post-operatively without the need for additional surgery. Many of the remaining 36 regained BCVA after enhancements.1
Risks More Prevalent in a Surgeon's First Cases
| Complications Noted by Vidaurri-Leal (n= 5000) |
| |
First Cases (n=200) |
Following Cases (n=4,800) |
| Intra-operative complications |
4.5% |
0.87% |
| Post-operative complications |
38.8% |
7.98% |
| Loss of BCVA |
3.0% |
0.81% |
In 1998, Jésus S. Vidaurri-Leal, MD presented "Complications in 5000 LASIK Procedures," a study that supports the existence of a learning curve with LASIK, at the American Academy of Ophthalmology Subspecialty Day. He broke his data into two categories: his first 200 cases performed in 1995 and his 4800 following cases. Among the surgeon's later 4800 cases, less than 1% experienced intra-operative complications. Post-operatively, 7.98% of these cases experienced complications, with a loss of best corrected visual acuity in .81%. This compares with complications 4.5% intra-operatively, 38.8% post-operatively, and a loss of best corrected visual acuity in 3% of his first 200 cases.2
| Intra-operative Complications Noted in the Lin & Maloney Study (n=1,019) |
| First Cases(n=100) |
Following Cases (n=600) |
Last Cases (n=300) |
| 6.0% |
2.3% |
0.3% |
The February, 1999 study by Doctors Lin and Maloney that considered 1,019 eyes also demonstrates a learning curve with refractive surgeries utilizing a hinged flap. This study noted a 6% intra-operative complication rate in the first 100 eyes compared to a statistically significantly lower 2.3% rate in the next 600 eyes. In the last 300 eyes, the Intra-operative complication rate dropped down to 0.3%.3
Other Risks
Other risks include corneal damage leading to permanent corneal scarring or swelling, droopy eyelid, contact lens intolerance and persistent discomfort. The majority of complications recorded in early studies were intra-operative. As microkeratome technology has improved, the incidence of these LASIK complications has diminished. Researchers expect further reductions as instrumentation becomes more sophisticated.
Suggestions for Further Reading
Wherever possible, we have provided links to the studies and articles we have cited. We encourage patients to read them in full, but realize that these articles have not been written for a lay audience.
1. CRS completes LASIK study treatment for approved range. Ocular Surgery News 1998; 11.
2. Vidaurri-Leal, JS. Complications in 5000 LASIK procedures. Refractive Surgery 1998 Reshaping the Future, a publication of American Academy of Ophthalmology Subspecialty Day 1998 - Refractive Surgery; 61-64.
3. Lin RT, Maloney RK. Flap complications associated with lamellar refractive surgery. American Journal of Ophthalmology 1999: 127(2) 129-136.
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