Effects of Serial Sessions of Activa Mask for the Treatment of Meibomian Gland Dysfunction.

INTRODUCTION: To analyze outcomes on objective ocular surface parameters and subjective symptoms of serial weekly sessions using the Activa mask in patients with meibomian gland dysfunction (MGD). METHODS: This is a prospective study including patients with symptomatic MGD who were treated with four weekly sessions using the Activa mask (SBM Sistemi, Turin, Italy). Noninvasive ocular surface examination was carried out before (T0) and 2 weeks after the last mask session (T1) using Idra (SBM Sistemi, Turin, Italy) for the measurement of: (1) noninvasive break-up time (NIBUT); (2) lipid layer thickness (LLT); (3) tear meniscus height (TMH); (4) meibomian gland loss (MGL) of upper and lower eyelids. The I-Pen tear osmolarity system (I-Med Pharma Inc, Dollard-des Ormeaux, Quebec, Canada) was used to measure tear osmolarity values. Ocular discomfort symptoms were ascertained by means of the ocular surface disease index (OSDI) questionnaire. RESULTS: All 25 patients (11 males, 14 females; mean age 57.1 ± 11.9 years) regularly completed the cycle of four mask sessions. No patients used prohibited medications, and no device-related adverse events were noted. At T1, mean values of NIBUT and LLT increased significantly compared to T0 (respectively from 6.0 ± 1.4 to 6.6 ± 1.2 s, P = 0.043, and from 53.2 ± 17.4 to 65.3 ± 16.3 nm, P < 0.001), while mean values of MGL and tear osmolarity decreased significantly (respectively from 17.1 ± 9.3 to 15.1 ± 8.0%, P = 0.014, and from 307.3 ± 12.2 to 301.5 ± 6.8 mOsm/l, P = 0.005). In parallel, OSDI score reduced significantly from 62.4 ± 11.7 at T0 to 34.5 ± 11.2 at T1 (P < 0.001). CONCLUSION: Weekly serial sessions using the Activa mask significantly improved objective parameters of the ocular surface as well as subjective ocular discomfort symptoms in patients with recalcitrant MGD. As a further benefit from the treatment, patients were able to avoid the use of concomitant medications, apart from tear substitutes, throughout the study.

Outcomes of serial sessions of Activa mask combined with intense pulsed light therapy in patients with Meibomian gland dysfunction.

BACKGROUND: To evaluate the effects on ocular surface signs and symptoms of serial sessions of heating and vibrating eye mask followed by intense pulsed light (IPL) therapy for the treatment of dry eye disease owing to meibomian gland dysfunction (MGD). METHODS: Consecutive patients with MGD whose signs and symptoms were not satisfactorily controlled with conventional therapy were included. Patients received 3 treatments performed at day 1, 15, and 45 incorporating a session with a newly-developed eye mask (Activa, SBS Sistemi, Turin, Italy) immediately followed by IPL therapy (E > Eye device, E-Swin, Paris, France). Patients were examined before the first session (T0) and 30 days after the last session (T1) for the measurement of: noninvasive break-up time (NIBUT); lipid layer thickness (LLT); tear meniscus height (TMH); meibomian gland loss (MGL); tear osmolarity. Ocular discomfort symptoms were ascertained by ocular surface disease index (OSDI) questionnaire. RESULTS: Thirty patients were ultimately included in the study. At T1, all objective ocular surface parameters improved significantly, except for TMH: NIBUT and LLT increased from 6.4 ± 1.7 to 8.6 ± 1.7 s and from 57.7 ± 15.5 to 81.3 ± 12.0 µm (all P < 0.001), while MGL and tear osmolarity decreased from 21.1 ± 17.3 to 17.0 ± 14.1% and from 302.0 ± 8.5 to 295.7 ± 6.9 mOsm/L (respectively, P = 0.004 and P < 0.001). In parallel, OSDI score decreased significantly from 49.8 ± 13.5 to 29.8 ± 10.6 (P < 0.001). In the historical control group of patients who underwent only IPL, NIBUT, LLT, tear osmolarity and OSDI improved significantly but not MGL and TMH. CONCLUSIONS: Serial sessions incorporating the application of an eye mask producing heating and vibration immediately followed by IPL therapy are able to improve all ocular surface parameters as well as ocular discomfort symptoms in MGD patients.

Surgical Antimicrobial Prophylaxis in Patients of Neonatal and Pediatric Age Subjected to Eye Surgery: A RAND/UCLA Appropriateness Method Consensus Study.

Ocular surgery encompasses a wide range of procedures, including surgery of the tear ducts, eyelid, cornea and conjunctiva, lens, ocular muscle, and vitreoretinal and iris surgery. Operations are also performed for the removal of tumors, repairs of ocular trauma and, finally, corneal transplantation. Antibiotic prophylaxis for the prevention of surgical site infections (SSIs) in ocular surgery is a complex field in which shared lines of action are absent. In light of the scarcity of shared evidence in the use of ocular antimicrobial prophylaxis for the pediatric population, this consensus document aims to provide clinicians with a series of recommendations on antimicrobial prophylaxis for patients of neonatal and pediatric age undergoing eye surgery. The following scenarios are considered: (1) intraocular surgery; (2) extraocular surgery; (3) ocular trauma; (4) ocular neoplasm; (5) ocular surface transplantations; (6) corneal grafts. This work has been made possible by the multidisciplinary contribution of experts belonging to the most important Italian scientific societies and represents, in our opinion, the most complete and up-to-date collection of recommendations regarding clinical actions in the peri-operative environment in eye surgery. The application of uniform and shared protocols aims to improve surgical practice, through the standardization of procedures, with a consequent reduction of SSIs, also limiting the phenomenon of antimicrobial resistance.

Effects of a New Formulation of Multiple-Action Tear Substitute on Objective Ocular Surface Parameters and Ocular Discomfort Symptoms in Patients with Dry Eye Disease.

INTRODUCTION: Recently, there has been a progressive shift from simple water-adding medications towards complex multi-action combined formulas aimed at disrupting different mechanisms within the dry eye disease (DED) vicious cycle. This study evaluated the efficacy and tolerability of Trimix eye drops (Off Health Italia, Italy), a combination of viscosity-enhancing hyaluronic acid, trehalose, and cationic liposomes comprising stearylamine and phospholipids, in patients with DED. METHODS: In this prospective, pilot study patients diagnosed with mild to moderate DED were enrolled and treated with Trimix eye drops three times daily for 2 months. Ocular surface workup was performed before (V0) and after therapy (V1) by means of IDRA (SBM Sistemi, Turin, Italy), for the measurement of (i) noninvasive break-up time (NIBUT); (ii) tear meniscus height (TMH); (iii) lipid layer thickness (LLT); (iv) infrared meibography (percentage of meibomian gland loss); (v) bulbar redness (Efron scale). Treatment tolerability was scored on a visual analog scale ranging from 0 (none/not at all) to 100 (much/very) for eight questions. Ocular discomfort symptoms were scored using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. RESULTS: Overall, 25 subjects (mean age 60.32 ± 14.55 years) were included in the study. At V1, TMH, NIBUT, and LLT significantly increased compared to V0 (from 0.29 ± 0.06 to 0.46 ± 0.06 mm, 6.34 ± 2.61 to 7.58 ± 2.52 s, and from 63.26 ± 17.15 to 68.42 ± 15.63 nm, respectively; all P < 0.04). Concerning ocular discomfort symptoms, SPEED score significantly improved at V1 (from 16.63 ± 6.32 to 8.30 ± 5.98; P < 0.001); moreover, treatment tolerability was high for all eight items investigated. CONCLUSIONS: Two-month treatment with Trimix formulation improved objective signs and subjective symptoms in patients with DED, showing also a good tolerability profile.

Glasses-Assisted 3D Display System-Guided Descemet Membrane Endothelial Keratoplasty Tissue Preparation.

PURPOSE: The aim of this study was to evaluate the feasibility of Descemet membrane endothelial keratoplasty (DMEK) tissue preparation using a glasses-assisted 3-dimensional (3D) display system and to compare it with a conventional surgical microscope. METHODS: Healthy pairs of human corneas suitable for penetrating keratoplasty surgery were selected for this study. The tissues were randomly divided into 2 groups. Each pair of corneas had 1 cornea (group 1) prepared with NGENUITY (Alcon) with a 5-second staining time with vision blue, and the fellow cornea (group 2) was prepared using a OPMI Lumera 700 surgical microscope (Carl Zeiss Meditec, Jena, Germany) with a 30-second staining time. DMEK graft preparation time, speed of stripping, graft width, and endothelial cell loss were evaluated. RESULTS: Twenty-eight pairs of corneas were included in this study. The graft preparation time was significantly higher in the 3D group than in the conventional group (498 ± 147 vs. 418 ± 85 seconds, P value = 0.031). The mean speed of stripping was 0.59 ± 0.081 mm/s in group 1 and 0.089 ± 0.005 mm/s in group 2 ( P value = 0.024). The mean endothelial cell density in group 1 and group 2 before tissue preparation was 2162 ± 115.21 and 2153 ± 122.45, respectively ( P value > 0.1). After tissue preparation, the endothelial cell density reduced to 1911 ± 150.72 in group 1 and 1998 ± 90.72 in group 2 ( P value = P value > 0.05). The graft width was 5.05 ± 0.71 mm in group 1 and 4.92 ± 0.23 mm in group 2 ( P value > 0.05). CONCLUSIONS: DMEK tissue preparation with 3D display system NGENUITY is feasible with a slightly increased preparation time. The improved visualization allows a reduced staining time that could be beneficial for eye banks because it may reduce the toxic effect of staining colorants.

Short-Term Effects of a Novel Eye Mask Producing Heat and Vibration for the Treatment of Meibomian Gland Dysfunction: A Pilot Study.

PURPOSE: To investigate the short-term effects on tear film parameters and ocular symptoms of a novel eye mask producing heat and vibration developed for the treatment of dry eye disease owing to meibomian gland dysfunction (MGD). METHODS: This is a pilot study including the first 20 consecutive patients (6 males, 14 females; mean age 52.4 ± 16.8 years) who were treated with a novel eye mask producing heat (42°) and vibration (up to 20 Hz) (Activa, SBS Sistemi, Turin, Italy) for 15 minutes. The treatment incorporates 2 phases in the following chronological order: 5 minutes of heating (phase I); 10 minutes of combination of heating and vibration (phase II). Noninvasive ocular surface examination was carried out before (T0) and 30 minutes after the mask session (T1) by means of Idra (SBS Sistemi, Turin, Italy) for the measurement of noninvasive break-up time (NIBUT) and lipid layer thickness (LLT). Patients' satisfaction after treatment was ascertained by asking the patients whether they perceived improvement from their baseline symptoms according to a 5-grade scale: none = 0; trace = 1; mild = 2; moderate = 3; high = 4. RESULTS: All patients completed regularly the mask session and no device-related adverse events were noted. NIBUT improved significantly from T0 to T1 (from 7.2 ± 1.8 s to 8.1 ± 2.1; P = 0.014). In parallel, also LLT improved from from T0 to T1 (72.5 ± 13.9 nm to 83.1 ± 16.1; P = 0.016). Seven patients (35% of the total) had a moderate satisfaction (grade 3) while 13 patients (65%) had a high satisfaction (grade 4) with treatment. CONCLUSIONS: This eye mask represents a novel well tolerated tool in the armamentarium of MGD treatments. Thirty minutes after the session, NIBUT and LLT increased significantly; furthermore, all patients reported an improvement of discomfort symptoms with a moderate to high satisfaction with treatment.

Diagnostic Performance of a Novel Noninvasive Workup in the Setting of Dry Eye Disease.

PURPOSE: To evaluate the diagnostic performance of a novel noninvasive automated workup employed for the diagnosis of dry eye disease (DED). METHODS: One hundred patients with mild to moderate DED and 100 matched control subjects were enrolled in this cross-sectional study. Ocular surface examinations were carried out by means of IDRA Plus (SBM Sistemi, Turin, Italy), which allows the automated evaluation of noninvasive breakup time (NIBUT), lipid layer thickness (LLT), tear meniscus height (TMH), infrared meibography for the measurement of meibomian gland loss (MGL), and blinking analysis. Continuous variables were compared between patients with DED and controls by using the Mann-Whitney U test. The area under the curve (AUC) of receiver operating characteristic curves was calculated. The correlations between ocular surface parameters were evaluated with Pearson correlation analysis. RESULTS: Patients with DED showed significantly lower values of NIBUT, LLT, and TMH compared to controls (6.9 ± 2.5 vs 10.4 ± 2.4 s, P < 0.001; 64.6 ± 20.3 vs 73.4 ± 21.9 nm, P = 0.003; 0.231 ± 0.115 vs 0.289 ± 0.164, P = 0.012, respectively). Conversely, no significant differences were observed for MGL and blinking analysis (both P > 0.05). NIBUT had the highest diagnostic power (AUC = 0.841, sensitivity = 0.89, and specificity = 0.69), followed by LLT (AUC = 0.621, sensitivity = 0.89, and specificity = 0.55), TMH (AUC = 0.606, sensitivity = 0.57, and specificity = 0.63), blink analysis (AUC = 0.533, sensitivity = 0.48, and specificity = 0.59), and MGL (AUC = 0.531, sensitivity = 0.54, and specificity = 0.48). In patients with DED, NIBUT showed a significant correlation with TMH (R = 0.347, P = 0.002) and blinking analysis (R = 0.356, P < 0.001), while blinking analysis was negatively correlated with MGL (R = -0.315, P = 0.008). CONCLUSIONS: The automated noninvasive workup validated in this study may be a useful tool for reaching a noninvasive diagnosis of DED with a good performance, especially for NIBUT.

Ocular Surface Workup in Patients with Meibomian Gland Dysfunction Treated with Intense Regulated Pulsed Light.

The purpose of the present study was to evaluate changes of signs and symptoms in patients with meibomian gland dysfunction (MGD) treated with intense regulated pulsed light (IRPL), and to further investigate which parameter could predict positive outcomes of the procedure. Twenty-eight patients who bilaterally received three IRPL sessions at day 1, 15, and 45 satisfied the criteria and were included in the study. Non-invasive break-up time (NIBUT), lipid layer thickness (LLT), meibography, tear osmolarity, and ocular discomfort symptoms were measured before and 30 days after the last IRPL session. Qualified or complete success was defined in the presence of an improvement of symptoms associated with an increase of NIBUT (< or ≥ 20%). After IRPL treatment, median NIBUT and LLT increased from 7.5 to 10.2 s and 2.0 to 3.0, respectively (p <0.001); tear osmolarity decreased from 304.0 to 301.0 mOsm/L (p = 0.002). Subjective symptoms improved after IRPL in 26 patients. Qualified success was reached in 34 eyes, while complete success in 16 eyes. Patients with lower baseline break-up time (BUT) values showed better response to treatment (p = 0.04). In conclusion, IRPL improved signs and symptoms in MGD patients, while lower baseline NIBUT values were predictive of better response to IRPL.

Intense Pulsed Light for the Treatment of Dry Eye Owing to Meibomian Gland Dysfunction.

Dry eye disease (DED) is an increasingly common condition and one of the most common complaints of patients. The vast majority of DED is caused by the so-called "evaporative" subtype, that is mainly caused by meibomian gland dysfunction (MGD). Intense pulsed light (IPL) devices employ high intensity pulses of polychromatic lights with a broad range of wavelength (515-1200 nm). IPL treatment has been utilized for years in the field of dermatology, and then its use was applied to ophthalmology for the treatment of MGD. Recently, a new device employing IPL was specifically designed for the periocular application. This procedure determines the thermal selective coagulation and ablation of superficial blood vessels and telangiectasias of the eyelids skin, reducing the release of inflammatory mediators and tear cytokines levels, and improving meibomian glands outflow. IPL treatment is noninvasive and easy to perform, lasts for only a few minutes and can be conducted in an office setting. In the present study, 19 patients underwent 3 sessions of IPL treatment. After treatment, both mean noninvasive break-up time and lipid layer thickness grade significantly increased, as a result of an improvement of tear film stability and quality, respectively. Conversely, no statistically significant changes were found for meibomian gland loss and tear osmolarity. Furthermore, the vast majority of the treated patients (17/19; 89.5% of the total) perceived an improvement of their ocular discomfort symptoms after IPL treatment. Although IPL treatment provides an improvement of both ocular surface parameters and ocular discomfort symptoms after one cycle of three sessions, regular repeated treatments are usually required to maintain the persistence over the time of its beneficial effects.

Ocular Surface Workup With Automated Noninvasive Measurements for the Diagnosis of Meibomian Gland Dysfunction.

PURPOSE: To analyze diagnostic performance of an ocular surface workup based on automated noninvasive measurements in the diagnosis of meibomian gland dysfunction (MGD). METHODS: Two hundred ninety-eight eyes of 149 patients with MGD and 54 eyes of 27 control patients were analyzed. Ocular Surface Disease Index (OSDI), noninvasive breakup time (BUT), lipid layer thickness, meibomian gland loss, and tear osmolarity were calculated. The correlations among variables in the MGD group were analyzed. The area under the curve (AUC) of receiver operating characteristic curves was calculated. RESULTS: OSDI, noninvasive BUT, and meibomian gland loss were significantly different between MGD and control groups (respectively, 37.9 ± 19.6 vs. 7.1 ± 2.8; 8.8 ± 3.6 vs. 11.0 ± 3.0; 28.0 ± 17.6 vs. 21.2 ± 13.0; always P < 0.05). Positive correlations were found between lipid layer thickness and noninvasive BUT and between meibomian gland loss and OSDI (respectively, r = 0.169, P = 0.004; r = 0.187, P = 0.004). Noninvasive BUT had the highest diagnostic power as a single parameter, followed by meibomian gland loss (respectively AUC = 0.686, AUC = 0.598). When the diagnosis of MGD was made based on either noninvasive BUT or meibomian gland loss being abnormal, sensitivity was 86.2% and specificity 38.5%. When the diagnosis was made on both noninvasive BUT and meibomian gland loss being abnormal, sensitivity was 39.3% and specificity 85.6%. CONCLUSIONS: This automated noninvasive ocular surface workup may represent a useful screening tool for the diagnosis of MGD. In case of positivity of either noninvasive BUT or meibomian gland loss, subsequent qualitative clinical tests should be performed to achieve a reliable diagnosis and more precise characterization of MGD.

Wavefront-guided treatment of symptomatic eyes using the LADAR6000 excimer laser.

PURPOSE: To evaluate the clinical results of wavefront-guided customized treatment of eyes that underwent previous keratorefractive surgery with clinically significant visual symptoms related to the presence of higher order aberrations, with or without defocus/astigmatism. METHODS: Twenty-eight consecutive eyes of 19 symptomatic patients underwent wavefront-guided custom photorefractive keratectomy (PRK with mitomycin C) to correct low and high order aberrations, using the LADAR-Vision platform. All eyes had manifest refractive spherical equivalent (MRSE) error from 0.00 to -4.25 diopters (D), and high order aberrations root-mean-square (RMS) values >0.80 microm for a 6.0-mm measurement diameter (mean: 1.18 microm). Eyes were examined at 1, 3, and 6 months postoperatively. Uncorrected (UCVA) and best spectacle-corrected visual acuity (BSCVA), MRSE, wavefront measurement of high order aberrations, and patient subjective evaluation were the parameters used to assess the treatment. RESULTS: Six months after treatment, all 28 eyes had an improvement in UCVA compared to preoperative values. Seventeen (60.7%) eyes gained lines of BSCVA (1 to 3 lines) whereas 1 eye lost 1 line. Although the amount of positive defocus was intentionally and empirically undercorrected in this study, MRSE was slightly hyperopic (mean +0.65 D, range: -0.25 to +1.75 D). All eyes showed a reduction in pre-existing high order aberrations, with a mean reduction of 47% (0.62 microm). Spherical aberration reduced the most (mean 60%), coma was reduced by a mean 29%, and all other terms were reduced by a mean 42% compared to preoperative values. Subjectively, all patients but 1 (both eyes treated) noticed a reduction in their pre-existing visual symptoms. Overall, the treatment was considered satisfactory by the patients in terms of visual quality gain. CONCLUSIONS: This series of consecutive treatments of symptomatic eyes indicates wavefront-guided custom ablation is an effective surgical option to reduce visually impairing high order aberrations and related visual symptoms. To avoid the resulting hyperopic shift, some significant nomogram adjustments are necessary, most often when pre-existing positive spherical aberration is present.

First clinical experience with the Alcon LADAR 6000 excimer laser.

PURPOSE: To evaluate the reliability and ergonomics and to assess the first clinical results provided by the new LADAR 6000 excimer laser used to correct myopia and astigmatism, both by conventional and wavefront-guided ablation. METHODS: Seventy-four consecutive eyes from 37 patients underwent LASIK as the first field evaluation protocol of the Alcon LADAR 6000 excimer laser. Forty-six eyes were treated by wavefront-guided ablation to correct a manifest spheroequivalent refractive error (MSRE) of -0.50 to -9.75 diopters (D) (mean: -4.19 D, cylinder range: 0.0 to -3.50 D). Twenty-eight eyes were treated by conventional ablation to correct MSRE of -1.00 to -7.00 D (mean: -3.11 D, cylinder range: 0.0 to -1.75 D). Uncorrected (UCVA) and best spectacle-corrected visual acuity (BSCVA), MSRE, and wavefront measurements were assessed. Follow-up was 3 months for all eyes. RESULTS: Three months after surgery, all eyes were within +/- 1.00 D of intended correction. Forty-three (93.5%) eyes treated with wavefront-guided ablation and 25 (89.3%) eyes treated with conventional ablation were within +/- 0.50 D. All eyes reached > or = 20/25 UCVA. UCVA > or = 20/20 was reached in 45 (97.8%) wavefront-guided eyes and 26 (92.9%) conventional eyes; 37 (80.4%) wavefront-guided eyes and 17 (60.7%) conventional eyes had 20/16 UCVA. None of the eyes treated lost > or = 2 lines of BSCVA. CONCLUSIONS: The LADAR 6000 excimer laser results proved to be at least as accurate, predictable, and safe as the results currently achieved with the LADARVision4000 excimer laser. The improved microscope illumination enhances visibility for better consistency and ease of use. The better ergonomics and software design of this platform improved patient flow.

Expanded range customcornea algorithms for myopia and astigmatism: one-month results.

PURPOSE: To evaluate the early clinical results achieved with an algorithm adjusted for an expanded range of correction in wavefront-guided customized ablation with the LADARVision4000 (Alcon Laboratories Inc, Fort Worth, Tex). METHODS: Fifty-five consecutive eyes from 31 patients underwent wavefront-guided, customablation laser in situ keratomileusis (LASIK) (Hansatome and BD 4000 microkeratomes, LADARWave aberrometer, LADARVision4000 laser system). These were normal myopic and astigmatic eyes that had never been operated on. The spherical equivalent refractive error was +0.30 to -8.13 diopters (D) (mean -4.26 +/- 2.14 D) and the astigmatism ranged from 0 to -3.75 D (mean -0.97 +/- 0.96 D). eyes were treated according to the CustomCornea protocol using the commercial LADARVision4000 platform. Patients were followed for at least 2 months and standard visual measurements were taken and recorded at 1 day and 1, 3, and 6 months after treatment. The results of treatment were assessed using the following parameters: uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA); manifest spherical equivalent refractive error; wavefront measurement of high order aberrations; and subjective reports of visual symptoms by patients. RESULTS: One month after LASIK, the mean manifest spherical equivalent refractive error was -0.18 +/- 0.41 D. Seventy-eight percent and 96% of eyes had manifest spherical equivalent refractive error within +/-0.50 D and +/-1.00 D of attempted correction, respectively, with 78% of eyes with 20/20 or better UCVA. Eyes with 20/16 and 20/12.5 BSCVA were 89% and 36%, respectively (55% and 7% preoperatively). The mean high order aberrations root-mean-square was 0.34 +/- 0.10 microm preoperatively and 0.35 +/- 0.09 microm postoperatively (6.0-mm pupil size). High order aberrations were either reduced, unchanged, or increased by <10% in 58% of eyes. Subjectively, patients reported no visual symptoms and had no complaints regarding the quality of their vision. CONCLUSION: The new optimized algorithm for higher refractive errors appears to be effective in improving BSCVA, and a minority of patients demonstrated an increase in the magnitude of high order aberrations when compared to preoperative aberrometry. A slight spherical equivalent refraction undercorrection will be addressed with future nomogram adjustments.

Wavefront-guided treatment of abnormal eyes using the LADARVision platform.

PURPOSE: To evaluate the clinical results of Alcon LADARVision4000 wavefront-guided customized treatment of eyes with myopia and/or astigmatism, and clinically significant visual symptoms related to the presence of higher order aberrations. METHODS: Seven consecutive abnormal eyes from seven patients underwent wavefront-guided CustomCornea (1 PRK, 6 enhancements after previous LASIK) to correct low and higher order aberrations, using the Alcon LADARVision4000 platform. Eyes were examined at 1 to 3 months after treatment; the longest follow-up examination was used for analysis. Uncorrected and best spectacle-corrected visual acuity, manifest refractive spherical equivalent error, and subjective visual symptoms were measured, as well as wavefront measurement of higher order aberrations. RESULTS: All seven eyes had an improvement in UCVA. One eye gained 2 lines of BSCVA, four eyes gained 1 line, and no eye lost any lines. Manifest refractive spherical equivalent error was slightly hyperopic in all eyes (+0.12 to +1.50 D). All eyes showed a reduction in pre-existing higher order aberrations, ranging between 1% and 48%. Spherical aberration was reduced most (mean 38% reduction), coma was reduced by a mean 14%, and all other terms were reduced by a mean 17% compared to preoperative values. Subjectively, all patients noticed a reduction in their pre-existing visual symptoms and reported visual performance comparable to their fellow asymptomatic eye. Overall, the treatment was considered very satisfactory by patients in terms of visual quality gain. CONCLUSION: Wavefront-guided custom ablation with Alcon's LADARVision4000 was effective in reducing higher order aberrations and related visual symptoms in this preliminary small series. Longer follow-up on more eyes is necessary to assess the accuracy of the algorithm in the correction of defocus, which resulted in a slight overcorrection in this study.

Laser in situ keratomileusis for hyperopia and hyperopic and mixed astigmatism with LADARVision using 7 to 10-mm ablation diameters.

PURPOSE: To evaluate the results of laser in situ keratomileusis (LASIK) performed to correct hyperopia, and hyperopic and mixed astigmatism using wider ablation diameters (optical zone diameter and overall ablation diameter) than those commonly used with the same and other lasers. METHODS: After flap creation using an Alcon SKBM microkeratome set for a 10-mm flap diameter, 53 eyes (33 patients) with a mean spheroequivalent attempted correction of +2.34 +/- 2.09 D underwent LASIK (Alcon LADARVision 4000) using a 7-mm optical zone diameter and a 3-mm transition zone for an overall 10-mm total ablation diameter. The nasal hinge was prevented from undesired ablation by the use of proprietary hinge protector software. Eyes were followed for 6 months after surgery. RESULTS: Six months after surgery, mean spheical equivalent refractive error was -0.22 +/- 0.41 D. There were 79.2% of eyes within +/- 0.50 D, and 98.1% within +/- 1.00 D of intended correction. Uncorrected visual acuity of 20/20 or better was achieved by 28 eyes (53%) and 20/40 or better by 50 eyes (94.3%). No meaningful visual complaints during nighttime hours, such as haloes or glare, were subjectively reported by patients. CONCLUSION: The use of larger ablation diameters in LASIK for hyperopia, and hyperopic and mixed astigmatism produced accurate results, early refractive stability, and good visual performance.

Scraping and mitomycin C to treat haze and regression after photorefractive keratectomy for myopia.

PURPOSE: To evaluate the efficacy, safety, and predictability of therapeutic scraping and application of a diluted 0.02% mitomycin C solution to treat haze and regression after photorefractive keratectomy (PRK) for myopia. METHODS: We performed a non-comparative, non-randomized retrospective study of 35 eyes of 30 patients who had previously undergone PRK for myopia and developed haze and regression after treatment. The range of refractive error after regression was -0.75 to -5.50 D (mean -2.92 D). Haze, ranging from grade 3 to 4 (scale: 0 to 4) caused a best spectacle-corrected visual acuity loss of 1 to 6 Snellen lines. All eyes were treated 6 to 12 months after PRK by scraping the stromal surface and application of a 0.02% mitomycin C solution for 2 minutes using a soaked merocel sponge. No laser ablation was performed. Corneal transparency, refractive error, and visual outcomes were evaluated over a 12-month follow-up period. RESULTS: All eyes had significant improvement in corneal transparency. Thirty-one eyes had haze grades lower than 1, which were maintained over time. Only four eyes showed haze grades 1 to 2 and two of them needed further treatment using the same technique. At 12 months after treatment, all eyes were within +/-1.50 of original intended correction (mean 0.04 +/- 0.63 D). BSCVA improved in all eyes. No toxic effects were observed during re-epithelialization or during follow-up. CONCLUSION: Single application of diluted mitomycin C 0.02% solution following scraping of the corneal surface was effective and safe in treating haze and regression after PRK.

Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy.

PURPOSE: To evaluate the results of the prophylactic use of mitomycin-C to inhibit haze formation after excimer laser photorefractive keratectomy (PRK) for medium and high myopia in eyes that were not good candidates for laser in situ keratomileusis (LASIK). SETTING: Carones Ophthalmology Center, Milan, Italy. METHODS: This prospective randomized masked study comprised 60 consecutive eyes (60 patients). The inclusion criteria were a spherical equivalent correction between -6.00 and -10.00 diopters (D) and inadequate corneal thickness to allow a LASIK procedure with a residual stromal thickness of more than 250 microm. The eyes were divided into 2 groups according to the randomization protocol. After PRK, the study group eyes were treated with a single intraoperative dose of mitomycin-C (0.2 mg/mL), applied topically with a soaked microsponge placed over the ablated area and maintained for 2 minutes. The control eyes did not receive this treatment. Refraction, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), and slitlamp evidence of corneal opacity (haze) or other visible complications were evaluated. RESULTS: No toxic or side effects were encountered postoperatively. No study group eye had a haze rate higher than 1 during the 6-month follow-up; 19 eyes (63%) in the control group did (P =.01). At 6 months, the between-group difference in the refractive outcome was statistically significant (P =.05), with 26 study group eyes (87%) and 14 control eyes (47%) within +/-0.50 D of the attempted correction. No study group eye had a BCVA loss during the follow-up; 7 control eyes had lost 1 to 3 lines at 6 months (P =.0006). CONCLUSIONS: The prophylactic use of a diluted mitomycin-C 0.02% solution applied intraoperatively in a single dose after PRK produced lower haze rates, better UCVA and BCVA results, and more accurate refractive outcomes than those achieved in the control group.