James J Salz

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.

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.

Evaluation and comparison of sources of variability in the measurement of corneal thickness with ultrasonic and optical pachymeters

Two studies were carried out to determine and compare the effects of several sources of variation on the measurement of corneal thickness using the standard optical pachymeter and three ultrasonic pachymeters. Sources of variation included: intra- and inter-session variation, inter-observer variation, left/right eye variation, and variations due to alternate settings of ultrasonic sound frequencies. It was found that the optical pachymeter had a) two to three times as much intra-session variation as that of the ultrasound pachymeters, b) significant inter-observer variation (P = 0.015), and c) significant differences between left and right eye thickness determinations (P less than 0.005). On the other hand, ultrasonic pachymeters demonstrated a) high reproducibility, b) no inter-observer variation, and c) no left/right eye variation. These results have implications for the use of pachymetry in measuring corneal thickness for radial keratotomy and other refractive surgery.

Three-year Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study

The Prospective Evaluation of Radial Keratotomy (PERK) study is a nine-center clinical trial of a standardized technique of radial keratotomy in 435 patients who had simple myopia with a preoperative refractive error between -2.00 and -8.00 diopters (D). We report results for one eye of each patient. The surgical technique consisted of eight incisions using a diamond micrometer knife with the blade length determined by intraoperative ultrasonic pachymetry and the diameter of the central clear zone determined by the preoperative refractive error. At three years after surgery, 58% of eyes had refractive error within one diopter of emmetropia; 26% were undercorrected, and 16% were overcorrected by more than one diopter. Uncorrected visual acuity was 20/40 or better in 76% of eyes. The operation was more effective in eyes with a preoperative refractive error between -2.00 and -4.37 diopters. Between one and three years after surgery, the refractive error changed by 1.00 diopter or more in 12% of eyes, indicating a lack of stability in some eyes.

LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision excimer laser system ☆

OBJECTIVE To assess the safety and effectiveness of the LADARVision active tracking narrow beam excimer laser system (Alcon Surgical, Orlando, FL) using laser in situ keratomileusis (LASIK) for correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism. DESIGN A multicenter, prospective non-randomized (self-controlled) comparative trial. PARTICIPANTS A total of 360 eyes, including 152 spherical hyperopic, 143 hyperopic astigmatic, and 65 mixed astigmatic, were treated for up to +6.00-diopter (D) sphere with up to -6.00-D cylinder. INTERVENTION Treatments were performed at six sites in the United States using a 6-mm optic zone with a 1.5-mm peripheral blend zone for a maximum ablation zone diameter of 9 mm. MAIN OUTCOME MEASURES Uncorrected visual acuity (UCVA), manifest refraction, vector analysis, best spectacle-corrected visual acuity (BSCVA), complications and adverse reactions, subjective symptoms, and patient satisfaction. RESULTS Six and 12 months of follow-up, respectively, were available on 143 and 117 spherical hyperopic eyes, 124 and 74 hyperopic astigmatic eyes, and 57 and 38 mixed astigmatic eyes, respectively. For spherical hyperopes at 6 and 12 months, UCVA was 20/40 or better in 93.4% and 93.9% of eyes, respectively. The manifest refraction spherical equivalent (MRSE) was within 0.50 D of intended in 65.0% and 74.1% of eyes, respectively, and within 1.00 D in 87.4% and 91.4%, respectively. Refractive stability was demonstrated in 94.2% or more of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 95.3% or more of eyes to 12 months. A loss of two lines of BSCVA occurred in 3.5% and 3.4%, respectively, and no eyes lost more than two lines. For hyperopic astigmats at 6 and 12 months, UCVA was 20/40 or better in 90.9% and 93.8% of eyes, respectively. The MRSE was within 0.50 D of intended in 60.5% and 73.0% of eyes, respectively, and within 1.00 D in 88.7% and 89.2% of eyes, respectively. Refractive stability was demonstrated in 96.5% or more of eyes, respectively, between the intervals of 1 to 3 months and 3 to 6 months and 95.5% or more to 12 months. A loss of two lines of BSCVA occurred in 5.8% and 1.4% of eyes, respectively, and no eyes lost more than two lines. For mixed astigmats at 6 and 12 months, UCVA was 20/40 or better in 92.6% and 94.4% of eyes, respectively. The MRSE was within 0.50 D of intended in 64.9% and 73.7% of eyes, respectively, and within 1.00 D in 87.7% and 94.7% of eyes, respectively. Refractive stability was demonstrated in 100% of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 97.0% or more to 12 months. A loss of two lines of BSCVA occurred in 1.9% and 0.0% of eyes, respectively, and no eyes lost more than two lines. CONCLUSIONS The data support safety and effectiveness of the LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision system.

Radial Keratotomy in Non-Human Primate Eyes

We performed a prospective study of the effects of radial keratotomy in the owl monkey. We compared a 16-incision and an eight-incision radial keratotomy, and followed the changes in corneal curvature, corneal thickness, endothelial cell counts, and intraocular pressure. We compared the results of the changes in these clinical factors with a histopathologic and ultrastructural analysis of the time-related changes after radial keratotomy in another group of animals. We found that the loss of initial corneal flattening following radial keratotomy corresponded with the contracture of the wound as demonstrated by histopathologic and ultrastructural study. This procedure results in a significant endothelial cell loss (14% to 15%), which is a result of the postsurgical inflammation associated with this surgery. Additionally, examination of the histopathologic structure of these corneas showed a high level of variability in the surgical incision depth, which we believe is responsible for the marked variations in the response to the surgical procedure.

Photorefractive keratectomy for low-to-moderate myopia and astigmatism with a small-beam, tracker-directed excimer laser.

OBJECTIVE To assess the safety and effectiveness of the Autonomous Technologies Corporation LADARVision excimer laser system for photorefractive keratectomy correction of myopia and astigmatism. DESIGN A multicenter, prospective, noncomparative case series. PARTICIPANTS The cohort consisted of 467 eyes corrected for spherical myopia and 211 eyes corrected for myopia with astigmatism. INTERVENTION Treatments were performed at six sites in the United States using a 6-mm ablation zone for spherical myopes and a 5.5-mm zone with a 1.0-mm blend for astigmats. MAIN OUTCOME MEASURES Visual acuity, subjective refraction, corneal haze, intraocular pressure, complications, adverse reactions, patient satisfaction, and corneal endothelial changes. RESULTS Twelve-month follow-up was available on 414 spherical eyes and 175 astigmatic eyes. The results for spherical eyes with correction between -1 and -5.99 diopters (D) were: uncorrected visual acuity (UCVA) of 20/40 or better achieved by 98.1%, 20/20 or better by 72%, 1.8% lost 2 lines and 0.3% lost greater than 2 lines of best spectacle-corrected visual acuity (BSCVA); 76.4% were within 0.50 D of the target correction and 94.4% were within 1.00 D. The results for myopia with astigmatism with spherical equivalent correction between -1 and -5.99 D were: UCVA of 20/40 or better in 97.4%, 20/20 or better in 61.7%, 2.5% lost 2 lines and no eyes lost greater than 2 lines BSCVA; 73.9% were within 0.50 D of the target correction and 95% were within 1.00 D. For spherical myopes combined with myopic astigmats corrected for 6 to 10 D, results were: UCVA of 20/40 or better in 93.4%, 20/20 or better in 61.2%, 2.3% lost 2 lines and no eyes lost greater than 2 lines of BSCVA; 67.2% were within 0.50 D of the desired correction and 87.8% were within 1.00 D. Refractive stability was achieved between 3 and 6 months for the spherical and astigmatic groups. No eyes had corneal haze graded as moderate or greater, and there was no significant decrease in endothelial cell density. CONCLUSIONS Patients treated for 1 to 10 D of spherical equivalent myopia, with or without astigmatism, showed early refractive stability, excellent UCVA, no significant loss of BSCVA, no loss of endothelial cell density, and very low levels of corneal haze to 12 months after surgery.

Laser in situ keratomileusis for myopia up to −11 diopters with up to −5 diopters of astigmatism with the summit autonomous LADARVision excimer laser system ☆

OBJECTIVE To assess the safety and effectiveness of the Summit Autonomous LADARVision active tracking narrow beam excimer laser system for laser in situ keratomileusis (LASIK) correction of myopia and astigmatism. DESIGN A multicenter, prospective noncomparative case series. PARTICIPANTS This cohort consisted of 177 eyes corrected for spherical myopia up to -11 diopters (D) and 170 eyes corrected for myopia up to -11 D spherical equivalent with astigmatism up to -5 D. INTERVENTION Treatments were performed at four sites in the United States using a 6-mm optic zone for spherical myopes and a 5.5-mm optic zone with a 1-mm blend for astigmats. MAIN OUTCOME MEASURES Visual acuity, subjective refraction, vector analysis, subject satisfaction, intraocular pressure, complications, and adverse reactions. RESULTS Six-month follow-up was available on 157 spherical eyes and 113 astigmatic eyes. For spherical myopes, uncorrected visual acuity (UCVA) was 20/20 or better in 60.5%, 20/25 or better in 80.3%, and 20/40 or better in 93.9%. The mean spherical equivalent was -0.29 +/- 0.45 D with 75.2% +/- 0.50 D and 94.9% +/- 1.00 D of intended. A loss of two lines of best spectacle-corrected visual acuity (BSCVA) occurred in 0.6%, and no eyes lost greater than two lines of BSCVA. For astigmatic myopes, UCVA was 20/20 or better in 52.0%, 20/25 or better in 74.5%, and 20/40 or better in 94.1%. The mean spherical equivalent was -0.23 +/- 0.49 D with 75.2% +/- 0.50 D and 95.6% +/- 1.00 D of intended. A loss of two lines of BSCVA occurred in 0.9%, and no eyes lost greater than two lines of BSCVA. Vector analysis showed that 99% of the intended cylinder was corrected on average with a mean angle of error of 4.2 degrees. Refractive stability was achieved between 1 and 3 months in 97.5% of spherical eyes and 99.4% of astigmatic eyes and confirmed between 3 and 6 months in 100% of both spherical and astigmatic eyes. CONCLUSIONS Eyes treated for myopia up to -11 D of spherical equivalent with or without astigmatism up to -5 D show early refractive stability, good UCVA outcomes, no significant loss of BSCVA, accurate correction of astigmatism, and slight undercorrection without a change from the photorefractive keratectomy algorithm and with a single treatment.

Femtosecond laser keratome creation of partial thickness donor corneal buttons for lamellar keratoplasty.

PURPOSE To evaluate the thickness and diameter accuracy of the IntraLase femtosecond laser in harvesting corneal discs for lamellar keratoplasty. The stromal bed quality of resected corneas was evaluated by scanning electron microscopy. METHODS Two IntraLase units were used to create corneal discs at 225-, 300-, 400-, and 500-microm thickness settings and 7-, 8-, 8.5-, and 9-mm diameter settings (n = 28). Achieved thickness was measured using a digital caliper and achieved diameter was measured using imaging software. Samples were preserved and processed for scanning electron microscopy to observe stromal bed quality. RESULTS On both units, the mean deviation from attempted thickness was -9.5 +/- 8.6 microm (range: +6 to -28 microm). All of the obtained corneal discs were circular (horizontal versus vertical diameters, P > .05). The raster pattern produced a smoother stromal bed compared to the spiral pattern. CONCLUSIONS The IntraLase femtosecond laser keratome provides depth and diameter accuracy even at increased depth settings. Stromal bed was smooth with the raster pattern and can further be smoothed by excimer phototherapeutic keratectomy treatment. Femtosecond laser lamellar keratoplasty is a promising procedure and clinical data are needed to determine effectiveness.

Ten years experience with a conservative approach to radial keratotomy

This retrospective study reports the results of radial keratotomy surgery on 225 eyes of 135 patients by one surgeon. Fifty-one percent of the eyes had four incisions and 45% had eight as the initial procedure. Fifteen percent of the eyes repeated surgery. The mean preoperative spherical equivalent refraction was -5.10 diopters (SD 1.90, range 1.20 to 11.60 D) and at 3 months to 1 year, the mean was -0.60 D (SD 1.00, range -4.80 to +3.40 D). For the entire series, 69% of the eyes achieved an uncorrected visual acuity of 20/40 or better, 73% were corrected to within +/- 1.00 D of emmetropia, and 3% were overcorrected by more than +1.00 D. For eyes with low preoperative myopia (-3.00 D and less), 100% achieved an uncorrected visual acuity of 20/40 or better, 97% were corrected to within +/- 1.00 D of emmetropia, and 3% were overcorrected by more than +1.00 D. For eyes with moderate myopia (-3.1 to -5.9 D), 73% achieved an uncorrected visual acuity of 20/40 or better, 81% were corrected to within +/- 1.00 D of emmetropia, and 3% were overcorrected by more than +1.00 D. For eyes with higher preoperative myopia (-6.0 to -11.60 D), 47% achieved an uncorrected visual acuity of 20/40 or better, 45% were corrected to within +/- 1.00 D of emmetropia and 3% were overcorrected by more than +1.00 D. One hundred eyes with a follow-up of 2 years or greater were studied for stability; 77% changed by less than 1.00 D from the 1 year value; 17% changed by 1.00 D or more in the hyperopic direction; 6% changed by 1.00 D or more in the myopic direction. There were no vision threatening complications and only one eye had a postoperative best spectacle corrected visual acuity of less than 20/40.