Timothy Cavanaugh

Results of Phase III Excimer Laser Photorefractive Keratectomy for Myopia

OBJECTIVE The purpose of the study is to determine safety and efficacy outcomes of excimer laser photorefractive keratectomy (PRK) for the treatment of mild-to-moderate myopia. DESIGN A prospective, multicenter, phase III clinical trial. PARTICIPANTS A total of 701 eyes of 701 patients were entered in the study; 612 eyes were examined at 2 years after surgery. INTERVENTION Intervention was photorefractive keratectomy using the Summit ExciMed UV200LA excimer laser (Summit Technology, Inc., Waltham, MA). The treatment zone diameter used was 4.5 mm in 251 eyes (35.8%) and 5 mm in 450 eyes (64.2%). Attempted corrections ranged from 1.50 to 6.00 diopters (D). MAIN OUTCOME MEASURES Predictability and stability of refraction, uncorrected and spectacle-corrected visual acuity, refractive and keratometric astigmatism, corneal haze, contrast sensitivity, subjective reported problems of glare and halo, and patient satisfaction were the parameters measured. RESULTS At 2 years, 407 (66.5%) eyes achieved 20/20 or better uncorrected visual acuity and 564 (92.5%) eyes achieved 20/40 or better visual acuity. Three hundred thirty-six (54.9%) eyes were within 0.5 D and 476 (77.8%) eyes were within 1.0 D of attempted correction. Stability of refraction improved with time; 86.8% of eyes were stable within 1.0 D from 6 to 12 months, 94% were stable from 12 to 18 months, and 96.3% were stable from 18 to 24 months. There was no evidence of progressive or late myopic or hyperopic refractive shifts. One hundred fourteen (18.6%) eyes gained 2 or more lines of spectacle-corrected visual acuity, whereas 42 (6.9%) eyes lost 2 or more lines; however, of the latter, 32 (76.2%) had spectacle-corrected visual acuity of 20/25 or better and 39 (92.9%) eyes had 20/40 or better. Four hundred forty-two (72.2%) corneas were clear, 138 (22.5%) showed trace haze, 20 (3.3%) mild haze, 9 (1.5%) moderate haze, and 3 (0.5%) marked haze. On patient questionnaires, 87 (29.7%) patients reported worsening of glare from preoperative baseline; 133 (50.1%) reported worsening of halo symptoms from baseline. CONCLUSIONS Photorefractive keratectomy appears effective for myopic corrections of -1.50 to -6.00 D. Uncorrected visual acuity is maximized in most eyes by 3 months, although some patients require between 6 months and 1 year to attain their best postoperative uncorrected visual acuity and some may require from 1 to 2 years for stabilization of refraction. Refraction stabilizes progressively without evidence of late myopic or hyperopic refractive shifts. Optical sequelae of glare and halo occur in some patients treated with a 4.5- or 5-mm treatment zone.

Corneal Topography of Phase III Excimer Laser Photorefractive Keratectomy: Characterization and Clinical Effects

PURPOSE To define qualitative patterns of corneal topography after excimer laser photorefractive keratectomy (PRK), assess changes in patterns, associations with clinical outcomes, and the accuracy of videokeratography in predicting results, and define quantitatively the optical zone contour. METHODS Computer-assisted videokeratography data obtained from 181 patients after PRK was analyzed. Topography patterns at two time points were characterized, and associations with clinical outcomes were tested. Power change predicted by topography was compared with refractive change, and cross-sectional power contours were analyzed. RESULTS Seven topography patterns were defined. At 1 year, 58.6% of corneas showed a homogeneous topography, 17.7% showed a toric-with-axis configuration, 2.8% showed a toric-against-axis configuration, 13.8% showed an irregularly irregular topography, 2.8% showed a keyhole/semicircular pattern, and 4.4% showed focal topographic variants. No central island patterns were found. Of the maps, 41% changed over time. Uncorrected vision, predictability, and patient satisfaction were best in the homogeneous group. Astigmatism increased in the irregular and toric-against-axis groups and decreased in the toric-with-axis group. There was no relation of topography pattern to best-corrected vision or subjective glare/halo. Cross-sectional power profiles showed a homogeneous power change for the central 3 mm with a diminution in correction toward the periphery. The topography unit tended to overestimate refractive change for corrections of 5 diopters or less and underestimate the change for corrections greater than 5 diopters. CONCLUSIONS Topography patterns after PRK are identifiable, time dependent, and may affect clinical outcomes. Understanding the actual corneal optical contour resulting from PRK may aid in improving both laser techniques and optical results in the future.

Phototherapeutic keratectomy for recurrent erosion syndrome in anterior basement membrane dystrophy.

PURPOSE To determine the outcome of patients who received phototherapeutic keratectomy (PTK) for recurrent erosion syndrome due to anterior basement membrane dystrophy (ABMD). DESIGN A retrospective, noncomparative case series. PARTICIPANTS Forty-eight eyes of 43 consecutive patients who underwent PTK for recurrent erosions occurring in ABMD at the Hunkeler Eye Center from 1991 to April 1995. All patients had previously failed at least one method of medical or surgical treatment for recurrent erosions and had slit-lamp findings of ABMD on initial evaluation. INTERVENTION The eyes each underwent manual superficial keratectomy and PTK with the Summit Omnimed excimer laser. MAIN OUTCOME MEASURES Data were analyzed by a retrospective chart review for 1, 3, 6, and 12 months for the 36 eyes with at least 12 months of follow-up data available. They were analyzed for preoperative and postoperative visual acuity, change in spherical equivalent, recurrence rate, and patient satisfaction. RESULTS The preoperative mean visual acuity was not statistically significantly different at 1 month after PTK. Statistically significant improvement in mean visual acuity was present at 3, 6, and 12 months. Recurrence of symptoms of recurrent erosion was present in 5 (13.8%) of 36 eyes during the 12-month follow-up period, which was managed with repeat PTK over the area of the cornea initially treated with PTK; 1 of 5 required a third PTK treatment. All recurrences presented within 6 months of PTK or repeat PTK. The mean dioptric change in spherical equivalent was not statistically significant. Patient satisfaction levels after PTK for recurrent erosions in ABMD were assessed in 21 (58%) of 36 patients on a scale of 0 to 5 (5 = most satisfied); the mean response was 4.14 of 5. CONCLUSIONS Phototherapeutic keratectomy is an effective treatment for recurrent erosions occurring in the setting of ABMD, is well tolerated, and may improve visual acuity. The rate of recurrence of erosions in ABMD treated with PTK is low during a 12-month follow-up period.

Corneal optical irregularity after excimer laser photorefractive keratectomy

Purpose: To assess the influence of corneal surface microirregularities on objective and subjective visual performance after photorefractive keratectomy (PRK). Setting: Multicenter clinical trial. Methods: The alpha version of the Potential Corneal Acuity (PCA) computer program, currently under development, was used to qualitatively and quantitatively analyze the corneal surface of 176 eyes of 176 patients 1 year after PRK. Color maps of corneal surface irregularities were reviewed and quantitative values (PCA) predicting best spectacle‐corrected visual acuity (BSCVA) as limited by the cornea were evaluated for associations with qualitative topography patterns, optical zone decentration, and clinical outcomes of BSCVA, uncorrected visual acuity (UCVA), subjective patient satisfaction, and a subjective glare/halo index. Results: Qualitatively, corneas after PRK were generally characterized by a ring of optical irregularity at the juncture of the ablation zone and untreated cornea. Standard corneal topography maps graded as irregular after PRK had a significantly higher PCA value than those graded as regular. There was a trend toward higher PCA values with greater optical zone decentration that was not statistically significant. Actual BSCVA was identical to that which the PCA value predicted in 32% of patients and was within one Snellen line in 71 %, within two lines in 89%, and within three lines in 94%. The correlation between the PCA and the glare/halo index and with subjective patient satisfaction was statistically significant. The relationship between PCA and UCVA was not significant. Conclusions: A ring of optical microirregularity of the corneal surface can appear at the juncture of the treated and untreated cornea after PRK, indicating that the optical zone edge might affect objective and subjective postoperative visual outcomes. Further understanding of corneal surface topography and refinement of the PCA program should help explain visual outcome after PRK.

Topographical analysis of the centration of excimer laser photorefractive keratectomy

ABSTRACT A major advantage of myopic photorefractive keratectomy (PRK) is the precision with which the excimer laser ablates corneal tissue. But like other refractive surgery procedures, PRK must solve the problem of accurately centering the treatment zone. We present our technique for PRK centration with postoperative corneal topographic data on 110 patients from Phase IIB and III of the clinical trials. The distance between the center of the post‐PRK flat zone and the corneal vertex was determined by topography in millimeters and meridian degrees. On average, treatment zones were decentered down and right 0.52 mm at 196.74 degrees; 92.73% were centered within 1.00 mm, while 57.27% were within 0.50 mm. The centration data were correlated to postoperative visual acuity as well as treatment zone diameter. Mean uncorrected visual acuity was 20/20 for decentrations up to 1.00 mm but fell to 20/30 for deviations greater than 1.00 mm. Best corrected acuity was also preserved below 1.00 mm but compromised above this level. No difference in decentration was found between 4.5 mm and 5.0 mm ablation zones. Our findings indicate that PRK centration is accurate within 1.0 mm in over 92% of cases and that visual acuity is relatively preserved despite deviations from perfect centration. Further technical improvements will enhance the accuracy of PRK.

A Multicenter Trial of Photorefracti*ve Keratectomy for Residual Myopia after Previous Ocular Surgery

Purpose: The Summit Therapeutic Refractive Clinical Trial is a nine-center prospective, nonrandomized, self-controlled trial to assess the efficacy, stability, and safety of using a standardized technique of excimer laser photorefractive keratectomy (PRK) to correct residual myopia in eyes with previous refractive surgery or cataract surgery. Patients and Methods: Eligible eyes with a mean residual myopia of -3.7 ± 1.8 diopters (D) (range, -0.63 to -11.00 D) underwent PRK with a 193-nm excimer laser for myopic corrections between -1.50 and -7.50 D. Standardized settings were used for the ablation zone, ablation rate, repetition rate, and fluence. One hundred seven of the first 114 treated eyes were examined 1 year after PRK, with 98% of eyes having had refractive keratotomy and 2% having had cataract surgery. Results: One year postoperatively, the mean manifest spherical equivalent refraction was -0.6 ± 1.4 D (range, -6.50 to 2.50 D); 63% of eyes were within ±1.00 D of the attempted correction; and uncorrected visual acuity was 20/40 or better in 74% of eyes. Twenty-nine percent of eyes lost two or more Snellen lines of best-corrected visual acuity, and central corneal haze was moderate or severe in 8% of eyes. Conclusion: Excimer laser PRK is effective in reducing residual myopia after previous refractive and cataract surgery. However, it is less accurate than PRK in eyes that did not undergo surgery and is more likely to cause a loss of best-corrected visual acuity 1 year after treatment.

Holmium: YAG Laser Thermokeratoplasty for Hyperopia

Holmium:YAG laser thermokeratoplasty (LTK), a procedure using a solid-state infrared laser to treat hyperopia, was performed on 10 patients in phase I and 16 patients in phase II--in a total of 29 eyes at the Hunkeler Eye Clinic. Phase II was redesigned after phase I results showed undercorrection and regression. The follow-up period ranged from 1 to 24 months (mean 10.9 months). A total of 79% of phase II patients were within +/- 1.00 D of intended correction at the 6-month visit. Looking at both phases together, no patients had J2 or better near vision preoperatively, but 75% had J2 or better at the 6-month visit. A total of 43% of eyes in phase II lost 1 line and 7% lost two lines of best spectacle corrected visual acuity due to induction of irregular astigmatism. The surgical challenges are to insure appropriate centration of the procedure about the optical axis. Concerns about regression and stability will be defined as these patients are followed through their 2-year visits.

Centration of excimer laser photorefractive keratectomy relative to the pupil

ABSTRACT The centration of excimer laser photorefractive keratectomy (PRK) is critical to the procedures success. We evaluated PRK centration in 49 patients using the EyeSys topography system. Ablation zone centration was measured from the corneal vertex and from the pupillary center using the pupil‐finding software. Centration was measured more accurately from the pupillary center (0.40 mm) than from the corneal vertex (0.44 mm). Right eyes were decentered less than left eyes. There was an unpredictable correlation between amount of decentration and postoperative visual acuities. The ability to measure centration of keratorefractive procedures precisely from the pupil is an important advance in topography technology.

Characteristics Influencing Outcomes of Excimer Laser Photorefractive Keratectomy

PURPOSE To identify preoperative and intraoperative characteristics associated with outcomes of photorefractive keratectomy (PRK). METHODS In the phase III multicenter clinical trials of the Summit Technology excimer laser for corrections of 1.5 to 6.0 diopters (D) of myopia, three principal outcomes of PRK on 612 patients were examined: (1) uncorrected visual acuity of 20/40 or better, (2) predictability of refractive outcome within 1.0 D of attempted correction, and (3) stability of refractive result between 12 and 24 months. Multiple logistic regression was used to test for independent associations of multiple preoperative and intraoperative characteristics with each of these outcomes. RESULTS Older age was independently associated with lesser likelihood of achieving 20/40 or better uncorrected visual acuity (odds ratio = 1.08 per incremental year of age, 95% confidence interval [CI] = 1.04-1.12) and with decreased predictability, specifically with overcorrection (odds ratio = 1.09, 95% CI = 1.06-1.12), but age was not associated with stability of refraction. Greater attempted correction was associated independently with a decreased likelihood of 20/40 or better uncorrected visual acuity (odds ratio = 2.78 for corrections of 3.5-5.5 D, 95% CI = 1.18-6.75; odds ratio = 4.19 for corrections of > or = 5.5 D, 95% CI = 1.66-10.58), with decreased predictability (odds ratio = 1.72 for corrections of 3.5-5.5 D, 95% CI = 1.05-2.85; odds ratio = 2.95 for corrections of > or = 5.5 D, 95% CI = 1.65-5.26), and with a reduced likelihood of stability of refraction (odds ratio = 3.46 for corrections of > or = 5.0 D, 95% CI = 1.32-9.11). No intraoperative characteristics were associated with any of the outcomes assessed. CONCLUSIONS Using this specific excimer laser system with an optical zone of 4.5 or 5.0 mm, patient age and attempted correction are important preoperative characteristics associated with postoperative uncorrected visual acuity and predictability of PRK. Stability of refraction is strongly associated with attempted correction. Such information may help guide patient selection, determine timing of fellow eye treatment, and suggest changes in the laser treatment algorithm for individual patients. Although these findings may be representative of PRK in general, similar analyses should be performed before modifying patient treatments using either a 6.0-mm treatment zone or other laser systems.

Classification of variable clinical response after photorefractive keratectomy for myopia

BACKGROUND Variation in healing response has been noted after excimer laser photorefractive keratectomy (PRK). METHODS A retrospective analysis of 116 eyes that underwent PRK for myopia was performed. Standard surgical protocol and postoperative corticosteroid treatment were followed for all eyes. Scattergrams of achieved correction versus attempted correction at 6 months after surgery were analyzed. Subepithelial corneal haze was compared with refractive outcome. RESULTS Three healing responses were observed. Normal responders (84.5%) showed a hyperopic overcorrection at 1 month with a gradual regression toward plano and good refractive outcome. Inadequate responders (11.2%) showed a pronounced early hyperopic overcorrection (greater than 1.50 diopters [D]) with minimal regression at 6 months. Aggressive responders (4.3%) displayed an early overcorrection with rapid regression toward myopia. Clear to trace subepithelial corneal haze was present at 6 months in 96% of normal and inadequate responders. Aggressive responders had more pronounced subepithelial haze at 6 months. CONCLUSION Variation in the amount of subepithelial healing response occurs after excimer laser PRK. Abnormal healing responses may be detected early in the postoperative period by correlation of refractive error with the amount of subepithelial haze.