Randomized, double-blind, placebo-controlled, crossover trial of oral doxycycline for epistaxis in hereditary hemorrhagic telangiectasia.

BACKGROUND: Vascular malformations in hereditary hemorrhagic telangiectasia (HHT) lead to chronic recurrent bleeding, hemorrhage, stroke, heart failure, and liver disease. There is great interest in identifying novel therapies for epistaxis in HHT given its associated morbidity and impact on quality of life. We aimed to measure the effectiveness of oral doxycycline for the treatment of epistaxis and explore mechanisms of action on angiogenic, inflammatory and pathway markers in HHT using a randomized controlled trial. METHODS: 13 HHT patients with epistaxis were recruited from the Toronto HHT Center at St. Michael's Hospital. Recruitment was stopped early due to COVID-19-related limitations. The study duration was 24 months. Patients were randomly assigned to the treatment-first or placebo-first study arm. We compared the change in weekly epistaxis duration and frequency, biomarkers, blood measurements, and intravenous iron infusion and blood transfusion requirements between treatment and placebo. RESULTS: There was no significant difference in the change in weekly epistaxis duration (p = 0.136) or frequency (p = 0.261) between treatment and placebo. There was no significant difference in the levels of MMP-9, VEGF, ANG-2, IL-6 or ENG with treatment. Hemoglobin levels were significantly higher (p = 0.0499) during treatment. Ferritin levels were not significantly different between treatment and placebo. There was no significant difference in RBC transfusions between treatment periods (p = 0.299). CONCLUSION: Overall, our study did not demonstrate effectiveness of doxycycline as a treatment for epistaxis in patients with HHT, though the study was underpowered. Secondary analyses provided new observations which may help guide future trials in HHT. Trial Registration ClinicalTrials.gov, NCT03397004. Registered 11 January 2018 - Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03397004.

Utility of modified Rankin Scale for brain vascular malformations in hereditary hemorrhagic telangiectasia.

BACKGROUND: Approximately 10% of hereditary hemorrhagic telangiectasia (HHT) patients harbour brain vascular malformations (VMs). Intracranial hemorrhage (ICH) from brain VMs can lead to death or morbidity, while treatment options for brain VMs also have associated morbidity. The modified Rankin Scale (mRS) may provide an approach to identifying HHT-brain VM patients with poor outcomes, and their predictors. We aimed to measure the relationship between mRS score and brain VM, brain VM number, as well as other aspects of HHT, at enrollment and during prospective follow-up. METHODS: 1637 HHT patients (342 with brain VMs) were recruited from 14 HHT centres of the Brain Vascular Malformation Consortium since 2010 and followed prospectively (mean = 3.4 years). We tested whether the presence of brain VM, other HHT organ involvement, and HHT mutation genotype were associated with worse mRS scores at baseline and during follow-up, using linear mixed models, adjusting for age, sex, and year of visit. RESULTS: Presence of brain VMs was not associated with worse mRS score at baseline and there was no significant worsening of mRS with prospective follow-up in these patients; 92% had baseline mRS of 0-2. HHT-related gastrointestinal (GI) bleeding was associated with worse mRS scores at baseline (0.37, 95% CI 0.26-0.47, p < 0.001), as were history of anemia (0.35, 95% CI 0.27-0.43, p < 0.001) and liver VMs (0.19, 95% CI 0.09-0.30, p < 0.001). Presence of pulmonary arteriovenous malformations (AVMs) was not associated with worse mRS scores at baseline. mRS score was not associated with either HHT genotype (Endoglin vs ACVRL1). Only GI bleeding was associated with a significantly worsening mRS during prospective follow-up (0.64, 95% CI 0.21-1.08, p = 0.004). CONCLUSION: Most HHT-brain VM patients had good functional capacity (mRS scores 0-2) at baseline that did not change significantly over 3.4 mean years of follow-up, suggesting that mRS may not be useful for predicting or measuring outcomes in these patients. However, HHT patients with GI bleeding, anemia history or liver VMs had worse mRS scores, suggesting significant impact of these manifestations on functional capacity. Our study demonstrates the insensitivity of the mRS as an outcomes measure in HHT brain VM patients and reinforces the continued need to develop outcomes measures, and their predictors, in this group.

Predictors of mortality in patients with hereditary hemorrhagic telangiectasia.

BACKGROUND: Retrospective questionnaire and healthcare administrative data suggest reduced life expectancy in untreated hereditary hemorrhagic telangiectasia (HHT). Prospective data suggests similar mortality, to the general population, in Denmark's centre-treated HHT patients. However, clinical phenotypes vary widely in HHT, likely affecting mortality. We aimed to measure predictors of mortality among centre-treated HHT patients. HHT patients were recruited at 14 HHT centres of the Brain Vascular Malformation Consortium (BVMC) since 2010 and followed annually. Vital status, organ vascular malformations (VMs) and clinical symptoms data were collected at baseline and during follow-up (N = 1286). We tested whether organ VMs, HHT symptoms and HHT genes were associated with increased mortality using Cox regression analysis, adjusting for patient age, sex, and smoking status. RESULTS: 59 deaths occurred over average follow-up time of 3.4 years (max 8.6 years). A history of anemia was associated with increased mortality (HR = 2.93, 95% CI 1.37-6.26, p = 0.006), as were gastro-intestinal (GI) bleeding (HR = 2.63, 95% CI 1.46-4.74, p = 0.001), and symptomatic liver VMs (HR = 2.10, 95% CI 1.15-3.84, p = 0.015). Brain VMs and pulmonary arteriovenous malformations (AVMs) were not associated with mortality (p > 0.05). Patients with SMAD4 mutation had significantly higher mortality (HR = 18.36, 95% CI 5.60-60.20, p < 0.001) compared to patients with ACVRL1 or ENG mutation, but this estimate is imprecise given the rarity of SMAD4 patients (n = 33, 4 deaths). CONCLUSIONS: Chronic GI bleeding, anemia and symptomatic liver VMs are associated with increased mortality in HHT patients, independent of age, and in keeping with the limited treatment options for these aspects of HHT. Conversely, mortality does not appear to be associated with pulmonary AVMs or brain VMs, for which patients are routinely screened and treated preventatively at HHT Centres. This demonstrates the need for development of new therapies to treat chronic anemia, GI bleeding, and symptomatic liver VMs in order to reduce mortality among HHT patients.

Laser in situ keratomileusis: surgical technique.

Laser in-situ keratomileusis is an increasingly popular technique for the correction of refractive errors that was initially described by Pallikaris in 1990. It involves the excimer laser ablation of corneal stroma beneath a hinged corneal flap that is created with a microkeratome. The purpose of this chapter is to report the LASIK surgical technique that has evolved at the Emory Vision Correction Center since 1995 when an investigation study of this technique for the correction of myopia began.

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.

Effects of laser in situ keratomileusis (LASIK) on the corneal endothelium 3 years postoperatively.

PURPOSE: To investigate the effects of laser in situ keratomileusis (LASIK) on the corneal endothelium 3 years postoperatively. METHODS: Patients who were subjects of a previous prospective study (Am J Ophthalmol 125:465-471, (April) 1998) were contacted for a follow-up analysis of the central corneal endothelium. Noncontact specular microscopy was performed 35 to 37 months after LASIK on 52 eyes of 27 patients of the original cohort of 98 eyes of 65 patients and six eyes of three patients who were previously lost to follow-up after their initial post-LASIK evaluation. Patient age ranged from 29 to 66 years at the time of the original LASIK procedure. Attempted corrections ranged from 2.25 to 14.5 diopters of myopia, giving theoretical ablation depths of 182 to 332 microm below the corneal surface. Forty-eight eyes (83%) had a history of preoperative contact lens use (3 to 33 years). Central endothelial cell density, coefficient of variation of cell size, and percent of hexagonal cells were analyzed using 72 to 152 cells from each image. Multivariate analysis was used to search for factors that might predict changes in cell density, coefficient of variation, and percent of hexagonal cells. RESULTS: The mean +/- SD preoperative cell density was 2,498 +/- 354 cells per mm(2), the mean coefficient of variation was 0.36 +/- 0.07, and the percent of hexagonal cells was 58 +/- 6. Three years after surgery there was no statistically significant change in the mean endothelial cell density (2,489 +/- 335 cells per mm(2); P = 0.88, paired t test) or the percent of hexagonal cells (60 +/- 7; P = 0.14, paired t test). The mean coefficient of variation was significantly lower postoperatively (0.32 +/- 0.04; P = 0.0006, paired t test); a repeated measures analysis showed that this significant improvement could not be explained by cessation of contact lens wear after LASIK (P = 0.34). Multivariate analysis did not identify any factors that were predictive of change in cell density, coefficient of variation, and percent of hexagonal cells. CONCLUSIONS: Laser in situ keratomileusis for the correction of 2.25 to 14.5 diopters of myopia had no significant effect on central corneal endothelial cell density or the percent of hexagonal cells 3 years after surgery. The coefficient of variation of cell size improved significantly 3 years after surgery.

Monocular diplopia related to asymmetric corneal topography after laser in situ keratomileusis.

PURPOSE: To show a specific relationship between monocular diplopia and corneal refractive asymmetry after laser in situ keratomileusis (LASIK). METHODS: One hundred thirty-eight eyes of 98 patients who underwent LASIK for myopia between -2.12 and -17.75 D were examined under room-lighted conditions. We examined 51 eyes at 2 weeks, 46 eyes at 3 months, 32 eyes at 6 months, and 9 eyes at 1 year after LASIK. We attempted to correlate the presence of monocular diplopia with their corneal topographical features. RESULTS: Eight eyes of five patients (five eyes at 2 weeks, three eyes at 3 months after LASIK) produced symptoms of monocular diplopia. These symptomatic patients had a common corneal topographical feature caused by decentralized or inhomogeneous ablation. Every pupillary area in the patients' topographies contained steeper and flatter areas. The range of refractive power variation in these asymmetric areas was at least 1.50 D. The location of the secondary image correlated with the direction of the steeper area in all eight eyes. Pinhole viewing eliminated or reduced the prominence of secondary images in every case. CONCLUSION: Monocular diplopia following LASIK appears to correlate with postoperative corneal refractive power variation inside the pupillary area, caused by decentralized or inhomogeneous ablation.

Videokeratography after excimer laser in situ keratomileusis for myopia.

OBJECTIVE: The purpose of this study was to define qualitative patterns of videokeratography after excimer laser in situ keratomileusis (LASIK) for myopia and to identify associations of videokeratography patterns with clinical variables. DESIGN: Single-center, retrospective, cohort study. PARTICIPANTS: One hundred twenty-six eyes of 68 patients with myopia who desired surgical correction of myopia ranging from -1.50 to -8.80 diopters. INTERVENTION: Myopia was corrected with LASIK using a Summit OmniMed/Apex excimer laser. Computer-assisted videokeratography data were acquired at 3 months after primary LASIK, and associations of videokeratography pattern with clinical variable were assessed. MAIN OUTCOME MEASURES: Seven subgroup ablation zone patterns were characterized using tangential curvature maps; these subgroups were combined into pooled symmetric and asymmetric groups. Associations with age, attempted correction, single-zone or multizone ablation, postoperative uncorrected and spectacle-corrected visual acuity, predictability, astigmatism, corneal uniformity, glare disability, and contrast sensitivity were analyzed. RESULTS: Thirty-two eyes (25.4%) showed a uniform pattern, 14 eyes (11.1%) showed a bow-tie pattern, 22 eyes (17.5%) showed a peninsula pattern, 22 eyes (17.5%) showed a semicircular pattern, 22 eyes (17.5%) showed an off-center blue spot pattern, 10 eyes (7.9%) showed an irregular pattern, and 4 eyes (3.2%) showed a central island pattern. Spectacle-corrected visual acuity, astigmatism, corneal uniformity, glare disability, and contrast sensitivity were significantly related to videokeratography pattern, although the difference among videokeratography groups was clinically small. Age, attempted correction, single- or multizone ablation, and postoperative uncorrected visual acuity and predictability were not predictive of videokeratography pattern. CONCLUSIONS: Most eyes in this study had an asymmetric videokeratography pattern 3 months after LASIK. Small but statistically significant differences were identified among the videokeratography patterns that potentially may affect postoperative quality of vision.

Multiple regression and vector analyses of laser in situ keratomileusis for myopia and astigmatism.

PURPOSE: To construct a quantitative model relating refractive results to laser settings and other factors. METHODS: A prospective clinical trial was performed, including 14 surgeons and 523 eyes of 278 patients who desired correction of myopia from -1.00 to -16.00 D (mean, -6.20 D) and astigmatism up to 6.00 D (mean, 1.10 D). Myopia and astigmatism were corrected by laser in situ keratomileusis (LASIK) with sequential spherical and cylindrical ablations using a 5.5-mm ablation zone and a transition zone to 7.0 mm. The Nidek EC-5000 excimer laser and the Chiron Automated Corneal Shaper were used. RESULTS: Surgically induced refractive changes 3 months after surgery were measured. Spherical ablation by LASIK produced a 19% greater refractive change than that predicted by the Nidek PRK algorithm. The laser setting needed to achieve each 1.00 D of cylinder correction induced 1.30 D change in spherical equivalent refraction (0.80 D more than expected). Patient age and nonlinear effects had small but statistically significant influences on refractive outcome. Sex, left/right eye, and surgeon were not significant factors. Residual variations in spherical equivalent refraction included a 0.50-D constant plus 9% of the predicted spherical equivlanet change. Residual variations in the parallel and orthogonal components of cylinder correction were, respectively, 28% and 13% of the predicted cylinder change plus a 0.30-D constant component. The standard deviation of axis alignment error for cylinder ablation was 3.7 degrees. CONCLUSIONS: Cylindrical ablation produced a spherical change that was larger than expected. To compensate for this, spherical ablation should be reduced in eyes with astigmatism. Variability in the correction of astigmatism was proportionally larger than that for spherical correction and was primarily due to magnitude rather than axis error.

Prospective randomized comparison of simultaneous and sequential bilateral laser in situ keratomileusis for the correction of myopia.

OBJECTIVE: To study the safety and efficacy of simultaneous bilateral laser in situ keratomileusis (LASIK). DESIGN: Prospective randomized clinical trial. PARTICIPANTS: Fourteen surgeons and 714 consecutive eyes of 357 patients who desired surgical correction of myopia ranging from -2.00 to -22.50 diopters. INTERVENTION: Patients were randomized to simultaneous or sequential bilateral LASIK. MAIN OUTCOME MEASURES: Primary outcome measures were safety and efficacy. Procedure safety was assessed, for simultaneous and sequential groups, by comparison of intraoperative and postoperative complication rates and the percentage of eyes losing two or more lines of spectacle-corrected visual acuity. Procedure efficacy was assessed by comparison of the percentage of eyes with uncorrected visual acuity better than or equal to 20/20 and 20/40 and the percentage of eyes within +/-0.50 and +/-1.00 diopters of intended outcome. RESULTS: Three hundred seventy-eight eyes were enrolled in the simultaneous group, and 331 eyes were enrolled in the sequential group. Mean follow-up was 10 months (+/-4.2 months standard deviation; range, 2 weeks-22 months). There was no significant difference in intraoperative complication rate (P = 0.55), loss of two or more lines of spectacle-corrected visual acuity (P = 0.87), or percentage of eyes within +/-0.50 diopters of intended correction (P = 0.17) between simultaneous and sequential groups. Postoperative complications were not significantly different in the two groups except for the unexplained more frequent epithelial ingrowth in the simultaneous group (2.9%) than in the sequential group (0.6%). The adjusted odds ratio for epithelial ingrowth in the simultaneous group was 1.02 (95% confidence interval, 1.01-1.08). There was no increased likelihood of epithelial ingrowth in the second of two simultaneously treated eyes (P = 0.95). CONCLUSION: The outcomes and complications of performing bilateral simultaneous LASIK were not significantly different from those of sequential treatments, with the unexplained exception of more frequent epithelial ingrowth in the simultaneous group.

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.

Prospective comparison of single-zone and multizone laser in situ keratomileusis for the correction of low myopia.

OBJECTIVE: This study aimed to determine whether there is a true difference in predictability between single-zone and multizone laser in situ keratomileusis (LASIK) for the correction of low myopia or whether any difference in predictability is because of a need for separate clinical nomograms for the two treatments. DESIGN: A prospective, randomized, clinical trial. PARTICIPANTS: Fourteen surgeons and 190 eyes of 95 patients with myopia who desired surgical correction of myopia ranging from -2.00 to -7.00 diopters (D) participated. INTERVENTION: Fellow eyes of patients with myopia undergoing bilateral simultaneous LASIK were randomized to single-zone and multizone ablation. Astigmatism was not corrected at the time of LASIK. MAIN OUTCOME MEASURES: Predictability, postoperative videokeratography, and contrast sensitivity were assessed at 3 months after surgery. RESULTS: At 3 months, r2 values relating laser setting to change in spherical equivalent refraction were 0.78 for single-zone and 0.76 for multizone ablation; mean outcome with respect to intended was -0.84 D (0.65 standard deviation [SD]) for single-zone and -0.62 D (0.78 SD) for multizone eyes (P = 0.035). There was no relationship between single-zone and multizone ablation and the likelihood of asymmetric postoperative videokeratography (P = 0.83). The only difference in contrast sensitivity was a significantly greater decrease in log contrast for multizone eyes at 12 cyc/deg under undilated conditions. CONCLUSIONS: There is no true difference in predictability between single-zone and multizone LASIK for the correction of low myopia. Separate clinical nomograms for single-zone and multizone LASIK should eliminate the difference in predictability that was observed in this clinical trial.

Effects of laser in situ keratomileusis (LASIK) on the corneal endothelium.

PURPOSE: To assess the effects of laser in situ keratomileusis (LASIK) on the corneal endothelium. METHODS: In a prospective study, the corneal endothelium of 98 eyes of 65 consecutive patients (mean age, 41 years; range, 22 to 66 years) was photographed before, 2 weeks after, and 12 weeks after LASIK for the correction of 2.75 to 14.5 diopters of myopia. Theoretical ablation depths were 200 to 330 microm below the corneal surface. Cell density, coefficient of variation, and percent of hexagonal cells were determined using 150 to 200 cells from each image. Eighty-eight eyes (91%) of 59 patients had a history of contact lens wear. RESULTS: The mean+/-SD preoperative endothelial cell density was 2,549+/-365 cells per mm2, and the mean coefficient of variation was 0.35+/-0.06. There was no statistically significant change in the mean endothelial cell density or mean coefficient of variation of cell size at the 2-week (2,561+/-360 cells per mm2 and 0.35+/-0.06) or 12-week (2,541+/-364 cells per mm2 and 0.35+/-0.05) postoperative examinations. The percent of hexagonal cells was not significantly changed 2 weeks postoperatively; however, 12 weeks postoperatively (P=.0413, two-tailed t test), the percent of hexagonal cells was decreased by 1%. CONCLUSIONS: Corneal endothelial cell density and morphology were unchanged 2 and 12 weeks after LASIK for the correction of up to 14.5 diopters of myopia. In this LASIK study, the correction of up to 14.5 diopters of myopia appears to cause no clinically significant effect on corneal endothelial cell density or morphology.

Contrast sensitivity and glare disability after radial keratotomy and photorefractive keratectomy.

OBJECTIVES: To study the effects of radial keratotomy (RK) and photorefractive keratectomy (PRK) on contrast sensitivity and glare disability using 4 different devices, and to correlate subjective complaints with obj ective scores of visual performance. METHODS: Preoperative contrast sensitivity for 30 eyes undergoing RK and 30 eyes undergoing PRK was compared with contrast sensitivity at 1, 3, and 6 months postoperatively using the CSV 1000, MCT (Multivision Contrast Tester) 8000, and Pelli-Robson chart. The BAT (Brightness Acuity Tester) and MCT 8000 were used to test for daytime and nighttime glare disability, respectively. At 3 and 6 months postoperatively, a questionnaire was administered to assess visual performance subjectively. RESULTS: Contrast sensitivity decreased after RK and PRK up to the sixth postoperative month, while glare disability was significantly increased at 1 month after PRK as determined by the MCT 8000 and the BAT, and at the third and sixth months after RK using the MCT 8000. Compared with RK, PRK significantly decreased contrast sensitivity as measured with the MCT 8000 at all spatial frequencies 1 month postoperatively. No significant difference in visual performance between patients undergoing RK and PRK was observed with the CSV 1000, the Pelli-Robson chart, or the BAT up to 6 months postoperatively. No consistent difference was found between glare disability scores of patients undergoing RK and PRK when measured with the MCT 8000. Subjective reports of problems with night driving and blurring correlated only with glare disability scores of the MCT 8000 3 months after RK. CONCLUSIONS: Both RK and PRK reduce contrast sensitivity and cause glare disability; however, the relative effect is highly dependent on the time postoperative testing is performed and the instrument used for testing. Contrast sensitivity and glare disability, as measured by the instruments used in this study, do not accurately reflect patients' subjective assessment of visual performance in daily life.

Results of phase III excimer laser photorefractive keratectomy for myopia. The Summit PRK Study Group.

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.

Prospective, randomized comparison of simultaneous and sequential bilateral LASIK for the correction of myopia.

PURPOSE: To study the safety and efficacy of simultaneous bilateral laser in-situ keratomileusis (LASIK) METHODS: Data were obtained from 254 consecutive patients that were randomized to simultaneous or sequential bilateral LASIK. RESULTS: 146 patients were enrolled in the simultaneous group and 108 patients were enrolled in the sequential group. Mean follow-up was 10 months (range 6-18). There was no significant difference in intraoperative complication rate (p = 0.34), loss of two or more lines of spectacle corrected visual acuity (p = 0.9), or percentage of eyes within +/- 0.50 D of intended (p = 0.63) between simultaneous and sequential groups. CONCLUSIONS: The risk of performing bilateral simultaneous LASIK is not significantly different from that of sequential treatments.

The effect of photorefractive keratectomy on the corneal endothelium.

PURPOSE: The authors prospectively investigated the effect of excimer laser photorefractive keratectomy (PRK) for myopia on the corneal endothelium. METHODS: Quantitative computer-assisted morphometric analysis of central and peripheral corneal endothelial cells was performed on 142 myopic eyes before and at 3 months, 1 year, and 2 years after PRK. The mean age of the subjects was 37 years (range, 21-66 years). Ninety-one (64%) of them had a history of contact lens wear. Mean attempted correction was -3.9 diopters (range, -1.6 to -6.0 diopters). RESULTS: The mean preoperative endothelial cell density was 2660 cells/mm2 centrally and 2776 cells/mm2 peripherally. There was no change in central endothelial cell density at any of the postoperative examinations. The peripheral cell density decreased 4.1% (P = 0.003) at 3 months and 6.2% (P = 0.0001) at 1 year. However, the peripheral cell density was not significantly different from the preoperative value at 2 years. The peripheral coefficient of variation of cell size was 7.8% lower 2 years postoperatively than it was preoperatively, and this improvement was attributable to cessation of contact lens wear after PRK. The decrease in peripheral endothelial cell density at 1 year correlated with the amount of attempted correction, but there was no correlation between attempted correction and the change in central or peripheral endothelial cell density 2 years postoperatively. CONCLUSION: For the correction of up to 6.0 D of myopia, PRK causes no detectable changes in central corneal endothelial cell density, but it does cause a transient, modest loss of peripheral corneal endothelial cells at 1 year. Variations in endothelial cell shape caused by contact lens wear resolve after PRK.

Late onset of corneal scar after excimer laser photorefractive keratectomy.

PURPOSE: We studied the occurrence of late scarring after photorefractive keratectomy and its response to topical corticosteroids and debridement during the course of follow-up of 950 eyes that had photorefractive keratectomy with excimer laser. METHODS: Five eyes of four patients developed localized corneal scars, decreased visual acuity, and increased myopia after five to 33 months of good visual acuity, with trace haze. In two eyes, scars were removed by debridement alone. In these two eyes, recurrent scars were treated by debridement, followed by aggressive treatment with topical corticosteroids. Two other eyes were treated with topical corticosteroids alone. The fifth eye, which developed a scar after debridement to correct a subjective visual distortion after photorefractive keratectomy, was treated with debridement followed by aggressive topical corticosteroids. RESULTS: Treatment with topical corticosteroids alone in two eyes improved uncorrected visual acuity slightly and decreased myopia, although the scars remained unchanged. Debridement without aggressive topical corticosteroid use resulted in rapid return of the scars and a decrease in visual acuity. Subsequent debridement after aggressive topical corticosteroid treatment resulted in resolution of scars and no recurrence after discontinuation of corticosteroids in one case. In another case, the scar recurred eight months after discontinuation of topical corticosteroids. In Case 4, the scar has not recurred as the topical corticosteroid dosage has been reduced. CONCLUSIONS: Patients who undergo photorefractive keratectomy should be counseled concerning the risk of late scarring, reexamined frequently after photorefractive keratectomy, and treated with topical corticosteroids after corneal trauma. Long-term treatment with topical corticosteroids may be required to prevent the recurrence of scars after debridement.

Refractive keratotomy in keratoconus suspects.

BACKGROUND: We utilized videokeratography to determine the frequency of keratoconus suspects in a refractive surgery population, and compared the results of refractive keratotomy in these patients to those of patients with normal corneal topography. METHODS: The records of 67 consecutive patients (120 eyes) undergoing refractive keratotomy were reviewed retrospectively. Quantitative measurements of relative inferior corneal steepening (inferior-superior value, I-S value) were obtained from preoperative videokeratography. RESULTS: Three of 120 eyes (3 of 67 patients, 4.5%) were identified as keratoconus suspects based on I-S (inferior-superior) values greater than +1.74 (range, +1.76 to +2.00), which represented two standard deviations (+/- 0.66) above the mean (+0.42). All three of these eyes achieved postoperative uncorrected visual acuity of 20/30 or better. Of those eyes with normal preoperative topography (I-S value +1.74 or less), 90 of 112 (80%) achieved postoperative uncorrected visual acuity of 20/30 or better, and 105 of 112 (94%) achieved 20/40 or better. CONCLUSIONS: Although long-term follow up is needed to confirm stability of refractive surgery outcome, it appears that keratoconus suspects can obtain acceptable results with refractive keratotomy. Studies on larger patient populations using videokeratography are needed to better define keratoconus, keratoconus suspects, and normal variants of corneal topography and to determine how eyes with abnormal topography respond to refractive keratotomy.

Phototherapeutic keratectomy for the treatment of nodular subepithelial corneal scars in patients with keratoconus who are contact lens intolerant.

The management of keratoconus with contact lenses may be complicated by punctate epithelial keratopathy, epithelial breakdown, and nodular, raised subepithelial scars. We report four consecutive cases of contact lens intolerance due to pain in patients with keratoconus and raised, nodular scars. Excimer laser phototherapeutic keratectomy (PTK) was used to treat all patients. Follow-up ranged from 7 to 14 months (mean: 10 months). All patients resumed rigid gas permeable (RGP) contact lens wear 2 to 4 weeks after surgery. Visual acuities ranged from 20/40 to 20/70 before surgery and improved to 20/25 or better in all patients postoperatively. PTK flattened the central cornea by an average of 5.43 D (range: 1.13-10.19 D); and refractive cylinder was reduced an average of 4.00 D (range: 3.25-5.25 D). We conclude that PTK may delay or avoid penetrating keratoplasty in selected patients with keratoconus who are contact lens intolerant due to nodular subepithelial scars.