George O. Waring

Complications of laser in situ keratomileusis for the correction of myopia

OBJECTIVE To determine the incidence and severity of complications from laser in situ keratomileusis (LASIK) for the correction of myopia by experienced and inexperienced surgeons. DESIGN Prospective, observational clinical study. PARTICIPANTS Fourteen surgeons and 1062 eyes of 574 myopic patients who desired surgical correction of myopia ranging from -2.00 to -22.50 diopters (D; mean, -7.57 D) and astigmatism no greater than 4.00 D participated in this study. INTERVENTION Myopia was corrected with LASIK. Astigmatism was corrected with arcuate keratotomy at the same time as the initial procedure or subsequently. MAIN OUTCOME MEASURES Primary outcome measures were change in best spectacle-corrected visual acuity (BSCVA) and the incidence of complications. RESULTS Eyes were followed for a mean of 9.5 months after their last surgical procedure (range, 2 weeks-21 months). Three hundred eighty-one eyes (36%) underwent 468 enhancement procedures 3 months or more after the initial treatment. There were 27 (2.1%) intraoperative and 40 (3.1%) postoperative complications. Laser ablation was not performed during the initial treatment of 17 (1.6%) eyes because of intraoperative complications. Seventy-four eyes gained 2 or more lines of BSCVA, while 50 eyes lost 2 or more lines of BSCVA. Only three eyes lost two or more lines of BSCVA to a level worse than 20/40. One eye with a flap buttonhole (BSCVA 20/50) also had an epiretinal membrane. The second eye (BSCVA 20/60) had a flap buttonhole that may have been related to a previous corneal transplant. The third eye (-22.50 D before surgery) had a rhegmatogenous retinal detachment develop, reducing BSCVA from 20/60 to 20/200. The incidence of intraoperative complications decreased from 3.1% during the first 3 months to 0.7% during the last 9 months of the study (P = 0.02). CONCLUSIONS LASIK is acceptably safe for the correction of myopia. Although complications occur in approximately 5% of cases, these rarely lead to visual loss of more than two Snellen lines and postoperative acuity below 20/40. Flap buttonholes were more likely to cause loss of BSCVA than free or incomplete flaps (P = 0.02); flap buttonholes may be more likely in eyes that have undergone previous surgery. Complication rates can be reduced as the surgical team gains experience.

Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study One Year After Surgery

The Prospective Evaluation of Radial Keratotomy (PERK) study is a nine-center, self-controlled clinical trial of a standardized technique of radial keratotomy in 435 patients who had physiologic myopia with a preoperative refraction between -2.00 and -8.00 diopters. The surgical technique consisted of eight incisions using a diamond micrometer knife with blade length determined by intraoperative ultrasonic pachymetry and the diameter of central clear zone determined by preoperative refraction. At one year after surgery, myopia was reduced in all eyes; 60% were within +/- 1.00 diopter of emmetropia; 30% were undercorrected and 10% were overcorrected by more than 1.00 diopter (range of refraction, -4.25 to +3.38 D). Uncorrected visual acuity was 20/40 or better in 78% of eyes. The operation was most effective in eyes with a refraction between -2.00 and -4.25 diopters. Thirteen percent of patients lost one or two Snellen lines of best corrected visual acuity. However, all but three eyes could be corrected to 20/20. Ten percent of patients increased astigmatism more than 1.00 diopter. Disabling glare was not detected with a clinical glare tester, but three patients reduced their driving at night because of glare. Between six months and one year, the refraction changed by greater than 0.50 diopters in 19% of eyes.

Penetrating Keratoplasty in Children

Retrospectively studied were 91 patients, 14 years of age or less, who had 152 penetrating keratoplasties in 107 eyes, with an average follow-up of 30.1 months. Survival analysis showed the probability of obtaining a clear graft at one year to be 60 +/- 8% in 45 eyes with congenital opacities, 70 +/- 8% in 31 eyes with opacities from trauma and 73 +/- 8% in 31 eyes with acquired nontraumatic opacities. Most failures occurred during the first postoperative year and were characterized by the gradual loss of graft clarity from undetermined cause. Twenty-nine percent (10) of the 34 eyes with congenital corneal opacities in which vision could be measured had a most recent visual acuity better than 6/120 (20/400). Irreversible amblyopia, glaucoma, other structural abnormalities of the anterior segment and mental retardation complicated visual rehabilitation in the congenital group. In the post-traumatic group, vision was better than 6/120 (20/400) in 45% (13) of 29 eyes, being limited by vitreoretinal pathology, fibrous ingrowth, and optic nerve damage from glaucoma. Visual acuity in the acquired, nontraumatic group was better than 6/120 (20/400) in 67% (20) of 30 eyes. The percentage of patients achieving 6/12 (20/40) or better in the congenital, post-traumatic, and nontraumatic groups were 3% (1/34), 17% (5/29), and 47% (14/30), respectively. In the congenital group, only patients with posterior polymorphous dystrophy obtained a visual acuity of 6/30 (20/100) or better. Preoperative vascularization of the cornea, persistent epithelial defects, and performance of lensectomy-vitrectomy were factors most highly correlated with poor graft survival.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical and Pathologic Description of 17 Cases of Corneal Intraepithelial Neoplasia

In 17 patients with corneal intraepithelial neoplasia (dysplasia), the epithelium formed a gray plaque at the corneal limbus adjacent to a conjunctival papilloma in seven cases, leukoplakia in six cases, a pterygium in one case, and a pinguecula in one case. The lesion was an extension of a similar neoplastic process of the conjunctiva in 15 cases, was associated with chronic conjunctivitis in one case, and was isolated to the cornea in one case. Fine white dots mottled the opalescent, ground-glass sheet, whose fimbriated leading edge consisted of sharply demarcated gray fingers that extended to the visual axis in some cases. The disorder can wax and wane spontaneously, shown in one case observed for 16 years. Histopathologically, the thick, hypercellular corneal epithelium abutted sharply against adjacent normal epithelium and demonstrated both cellular pleomorphism and poor intercellular adhesion in the deeper layers. The adjacent conjunctival neoplastic lesions ranged from mild dysplasia to invasive squamous cell carcinoma. Ultrastructurally, the corneal epithelium showed a marked decrease in desmosomal attachments, an abundance of intracytoplasmic filaments characteristic of keratin, and a loss of epithelial basement membrane and hemidesmosomes. The lesion did not extend into Bowmans zone. We classify this dysplastic process as a mild form of corneal intraepithelial dysplasia, a term used to designate the spectrum of epithelial changes ranging from dysplasia to carcinoma in situ. The virulence of the corneal lesion itself is low.

Penetrating Keratoplasty for Herpes Simplex Keratitis and Keratoconus: Allograft Rejection and Survival

To determine the relationship between corneal allograft rejection and failure, we studied patients who underwent penetrating keratoplasty for herpes simplex keratitis (n = 82) and keratoconus (n = 345), two frequent indications for keratoplasty in young patients, using survival analysis. For first grafts for herpes, the probability of survival was significantly less than it was for keratoconus (P less than 0.0001). For second grafts, this difference was less pronounced, and for three or more grafts, the difference in survival was not significant. The incidence of rejection episodes was similar in first grafts for herpes (16.6%) and keratoconus (18.5%) (P greater than 0.05). However, the incidence of rejection episodes in regrafts for herpes was significantly greater than in keratoconus (23.7 versus 17%, P less than 0.01). The incidence of failure after rejection episodes (first grafts and regrafts combined) was significantly greater in grafts for herpes (52.4 versus 16.2%, P less than 0.001). Because survival after multiple regrafts in both groups is poor, additional measures, such as tissue matching, may be necessary to improve the likelihood of success in these high-risk cases.

Bacterial and Fungal Endophthalmitis After Penetrating Keratoplasty

We analyzed 1,010 consecutive penetrating keratoplasties to determine the incidence of postoperative endophthalmitis, the frequency of positive donor rim cultures, and whether a correlation between these two factors exists. There were three cases of bacterial endophthalmitis, all caused by streptococci, and one case of Candida albicans endophthalmitis. In all cases except one case of streptococcal endophthalmitis, the same organism was cultured from the donor rim. We cultured 138 organisms from 128 of 932 donor rims (14%). A remarkable percentage of gram-positive organisms were resistant to gentamicin, the only antibiotic contained in corneal storage media. On the basis of our data and previously published data, we believe that donor material is frequently the source of microorganisms in endophthalmitis after penetrating keratoplasty.

Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study Five Years after Surgery

In the Prospective Evaluation of Radial Keratotomy (PERK) Study, 793 eyes of 435 patients with 2 to 8 diopters (D) of myopia received a standardized surgery consisting of 8 incisions with a diamond-bladed knife set at 100% of the thinnest paracentral ultrasonic corneal thickness measurement and a diameter of the clear zone of 3.0 to 4.5 mm; 97 eyes (12%) received an additional 8 incisions. There were 757 eyes (95%) followed for 3 to 6.3 years. After surgery, uncorrected visual acuity was 20/40 or better in 88% of eyes. The refractive error was within 1 D of emmetropia for 64% of eyes; 19% were myopic and 17% were hyperopic by more than 1 D. Between 6 months and 5 years after surgery, 22% of the eyes had a refractive change of 1 D or more in the hyperopic direction. For 25 eyes (3%) there was a loss of 2 or more lines of best spectacle-corrected visual acuity.

A randomized trial of intraocular lens fixation techniques with penetrating keratoplasty

PURPOSE Pseudophakic corneal edema is the principal indication for penetrating keratoplasty in the United States. Currently, three techniques of intraocular lens (IOL) fixation during penetrating keratoplasty for this condition are commonly used--flexible anterior chamber IOL (AC IOL) implantation, iris suture fixation of a posterior chamber IOL (PC IOL), and transscleral suture fixation of a PC IOL. This study represents the first prospective, randomized comparison of these three techniques. METHODS One hundred seventy-six consecutive patients with pseudophakic corneal edema who underwent penetrating keratoplasty with IOL exchange were randomized to one of the three implantation techniques. Standardized evaluations were performed at baseline and at 6, 12, and 18 months postoperatively. Life-table analysis provided cumulative risk estimates for specific complications. RESULTS Randomization produced comparable groups at baseline. The cumulative risk of macular edema was significantly less for the iris fixation cohort than for either the AC IOL or scleral fixation group. A complications index was constructed based on the major adverse outcomes of glaucoma escalation, cystoid macular edema, IOL dislocation, and graft failure. A significantly lower risk of complication was found for iris compared with scleral fixation of PC IOLs. CONCLUSION The authors conclude that transscleral fixation of the PC IOL at the time of penetrating keratoplasty for pseudophakic corneal edema is associated with a greater risk of adverse outcome than iris fixation of a PC IOL.

Determination of Corneal Image-forming Properties from Corneal Topography

Keratometry provides useful information about the corneas image-forming properties, such as corneal astigmatism, but is inaccurate on irregular corneas. Quantitative corneal topographic information is now obtainable on irregular corneas, but is difficult for the clinician to interpret. We developed a method to determine the spherical power, astigmatism, and topographic irregularity of a cornea by finding the best-fit spherocylinder that was closest to its measured topography. Keratometric measurements and two videokeratographs were gathered prospectively on 262 normal and abnormal corneas. The best-fit measurements of spherical power, astigmatism, and topographic irregularity were reproducible with one standard deviation of 0.75 diopter or better; agreement with keratometric measurements in normal eyes was good (0.60 diopter or better). Topographic irregularity averaged 0.1 diopter on precision spheres, 0.4 diopter on 146 normal eyes, 0.8 diopter on 29 eyes after radial keratotomy, 2.0 diopters on 58 eyes after penetrating keratoplasty, and 3.0 diopters on 29 eyes with advanced keratoconus. We conclude the following: basic corneal image-forming properties can be measured from videokeratographs; the properties can be determined, by our methods, on irregular corneas in which keratometry is unreliable; and topographic irregularity provides a measure of irregular astigmatism.

Complications of radial and transverse keratotomy.

Radial keratotomy for myopia and transverse keratotomy for astigmatism are the most commonly performed refractive surgical procedures. A decade of experience with modern techniques has produced considerable literature on the complications of keratotomy. Vision-threatening complications (bacterial keratitis, traumatic rupture of the globe through weakened keratotomy scars, endophthalmitis, cataract formation from surgical trauma to the lens) are quite rare, occurring in less than 1% of eyes in published series. The most common side effects affect most patients in the first few months after surgery: pain for 24 to 48 hours, transient glare and light sensitivity, and fluctuating visual acuity. The most common persistent complications are overcorrection and undercorrection. Persistent irregular astigmatism occurs in almost all cases in the region of the incision scars, but it is rarely severe enough to reduce spectacle acuity. Most individuals have mild glare, but this is rarely disabling. Diurnal variation of refraction in visual acuity occurs commonly, but the magnitude of the fluctuation is seldom enough to require multiple pairs of spectacles. Longterm refractive stability occurs in approximately half of eyes by six months, but approximately one in four eyes will experience continued change over six months to four years. Complications, such as scarring from intersecting keratotomy incisions, irregular astigmatism resulting from multiple reoperations, and overcorrections with the attendant early onset of symptomatic presbyopia are becoming much less frequent.