A four-years retrospective study: Clinical outcomes of XEN45 in patients with glaucoma.

INTRODUCTION: To evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma. METHODS: Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean IOP lowering from preoperative values. RESULTS: Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN-alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+Phacoemulsification). The mean preoperative intraocular pressure (IOP) was significantly higher in the XEN-alone (22.2±5.9 mmHg) than in the XEN+Phaco (19.8±4.5 mmHg) group (p=0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5±5.0 mmHg to 15.8±4.4 at year-4, p<0.0001. The mean preoperative (95% CI) IOP was significantly lowered from 22.2 (20.6 to 23.8) mmHg and 19.8 (19.1 to 20.6) mmHg to 15.6 (12.2 to 16.9) mmHg and 15.9 (15.2 to 16.5) mmHg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p<0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6±1.0 drugs to 1.3±1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p=0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure. CONCLUSION: XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduce the need of ocular hypotensive medication in the long-term.

Detecting Optic Atrophy in Multiple Sclerosis Patients Using New Colorimetric Analysis Software: From Idea to Application.

Neuro-ophthalmologists typically observe a temporal pallor of the optic disc in patients with multiple sclerosis. Here, we describe the emergence of an idea to quantify these optic disc color changes in multiple sclerosis patients. We recruited 12 multiple sclerosis patients with previous optic neuritis attack and obtained photographs of their optic discs. The Laguna ONhE, a new colorimetric software using hemoglobin as the reference pigment in the papilla, was used for the analysis. The papilla of these multiple sclerosis patients showed greater pallor, especially in the temporal sector. The software detected the pallor and assigned hemoglobin percentages below normal reference values. Measurements of optic disc hemoglobin levels obtained with the Laguna ONhE software program had good ability to detect optic atrophy and, consequently, axonal loss in multiple sclerosis patients. This new technology is easy to implement in routine clinical practice.

Analysis of optic disk color changes in Alzheimer's disease: a potential new biomarker.

PURPOSE: In the present study, we evaluated changes in the retinal nerve fiber layer (RNFL) and optic disk color (i.e., the level of paleness as an indirect sign of axonal loss) in patients with Alzheimer's disease (AD) compared with healthy controls. The usefulness of this method as a new biomarker for AD was also evaluated. METHODS: Fifty-six patients with mild or moderate AD and 56 sex-and age-matched healthy subjects were included in this cross-sectional study. All subjects underwent a complete neuro-ophthalmologic examination, including analysis of the RNFL thickness with Cirrus optical coherence tomography (OCT). One photograph of the optic disk was obtained using a Canon CF 60 DSi retinograph, and new colorimetric analysis software (Laguna ONhE) was used to detect color changes in the photographs based on hemoglobin (Hb) values as reference pigment. RESULTS: Mean Hb percentage and Hb content in the outer ring, which corresponds with the neuroretinal rim, calculated by the Laguna ONhE program were significantly lower in AD patients than in healthy controls (P<0.005). OCT measurements revealed that the mean RNFL thickness was significantly decreased in AD patients compared with healthy controls (P<0.003). CONCLUSION: Analysis of the optic disk color assessed by Laguna ONhE software revealed papillary paleness due to axonal loss and perfusion alterations, even in the early stages of AD. Application of this simple method in routine clinical practice may provide a good biomarker of AD.

Measuring hemoglobin levels in the optic disc of Parkinson's disease patients using new colorimetric analysis software.

Objective. To evaluate a new method of measuring hemoglobin (Hb) levels and quantifying the color changes in the optic nerve head of Parkinson's disease (PD) patients. We also compared differences in retinal nerve fiber layer (RNFL) thicknesses obtained using spectral domain optical coherence tomography (OCT) device between PD group and healthy group. Methods. One hundred and fifty-five PD patients and 91 sex- and age-matched healthy subjects were included in this cross-sectional study. OCT examinations and one photograph of the optic disc were performed. The Laguna ONhE ("optic nerve hemoglobin"; Insoft SL, Tenerife, Spain) software was used to analyze the Hb level on the acquired optic disc photographs. Results. PD patients exhibited significantly reduced mean optic disc Hb percentages (57.56% in PD, 67.63% in healthy subjects; P = 0.001) as well as reduced Hb in almost all analyzed sectors, with the largest differences detected in the inferior and nasal sectors. RNFL parameters were significantly reduced in PD patients compared with healthy subjects, especially in the inferior quadrant. Conclusions. Measurements of optic disc Hb levels obtained with the Laguna ONhE software had good ability to detect optic nerve color changes (more papillary paleness and consequently this could suggest optic atrophy and axonal loss) in PD patients.

Diagnostic ability of a new method for measuring haemoglobin levels in the optic nerve head in multiple sclerosis patients.

AIMS: To evaluate a new method for measuring haemoglobin (Hb) levels and quantifying the colour changes in the optic nerve head of multiple sclerosis (MS) patients to detect axonal loss and consequently optic disc atrophy. MATERIAL AND METHODS: 40 MS patients and 40 age and sex-matched healthy subjects were included in this prospective cross-sectional study and underwent a full ophthalmological examination, including three photographs of the optic disc. The Laguna ONhE ('optic nerve hemoglobin'; Insoft SL, Tenerife, Spain) software was used to obtain the Hb analysis in each of the 24 sectors and average Hb of optic disc photographs acquired. Reproducibility of measurements provided by Laguna ONhE program was analysed. RESULTS: MS patients showed significant reduction of optic disc Hb percentages in average Hb (58.99% in MS, 65.39% in healthy subjects; p<0.001) and in almost all analysed sectors with the largest differences in temporal sectors. Laguna ONhE program showed good reproducibility measuring Hb percentages in MS patients and healthy subjects. CONCLUSIONS: Measurements of optic disc Hb levels obtained with Laguna ONhE software had good ability detecting optic atrophy and axonal loss in MS patients. This method had good reliability and is easy to implement in routine clinical practice.

Measuring hemoglobin levels in the optic nerve head: comparisons with other structural and functional parameters of glaucoma.

PURPOSE: We evaluated and compared the ability of a new method for measuring hemoglobin (Hb) levels at the optic nerve head (ONH) to that of visual field evaluation, scanning laser ophthalmoscopy (HRT), scanning laser polarimetry (GDx), and optical coherence tomography (OCT) for diagnosing glaucoma. METHODS: Healthy eyes (n = 102) and glaucomatous eyes (n = 101) underwent reliable Oculus Spark perimetry, and imaging with the HRT, GDx, and Cirrus OCT. In addition, ONH color images were acquired with a non-mydriatic fundus camera. The Laguna ON(h)E program then was used to calculate the Hb amount in each of 24 sectors of the ONH. Sensitivities at 95% fixed specificity, diagnostic agreement, and linear correlations between parameters with the best diagnostic ability were calculated. RESULTS: The glaucoma discriminant function (GDF) of the Laguna program, evaluating Hb in the vertical intermediate sectors and center/periphery Hb amount slope, yielded an 89.1% sensitivity and 95.1% specificity, which was superior or similar to the other tests. The best GDF diagnostic agreement was for the OCT-vertical cup-to-disc (C/D) ratio (kappa = 0.772) and the final phase Spark pattern SD (kappa = 0.672). Hb levels correlated strongly with the Spark mean sensitivity (first phase 0.70, final phase 0.71). Hb also correlated well with the Reinhard OW Burk discriminant function of the HRT (0.56), nerve fiber indicator of GDx (-0.64), and vertical C/D ratio of OCT (0.71). CONCLUSIONS: Hb levels evaluated by color analysis of ONH photographs had high reproducibility, a high sensitivity-specificity balance, and moderate to strong agreement with other structural and functional tests.

Comparison of the efficacy and safety of contact versus peribulbar anaesthesia in combined eye surgery.

PURPOSE: To compare the combined levels of comfort, the presence of complications and the results of phacotrabeculectomy surgery obtained with 2 different forms of anaesthesia: topical contact anaesthesia and peribulbar injected anaesthesia. PROCEDURES: In total, 120 consecutive patients undergoing phacotrabeculectomy were randomly assigned to each anaesthesia group. The patients were asked to rate their pain level on a 5-point scale at 3 time points during the procedure. Early and late surgical complications and clinical parameters of success were evaluated. RESULTS: Administration of contact anaesthesia was clearly associated with less pain than injection of peribulbar anaesthesia. The amount of pain or discomfort experienced during or following surgery did not differ between the patient groups. No long-term differences in the tensional results were observed between the groups of the study. CONCLUSION: The application of contact anaesthesia in the phacotrabeculectomy procedure provides a level of comfort and safety that is comparable to that achieved with peribulbar anaesthesia. Likewise, patients that received contact anaesthesia were as comfortable as patients that received the peribulbar injection of anaesthesia, not only during the immediate postoperative period, but also in terms of their tensional results and their visual acuity in the mid and long term.

Contact-topical plus intracameral lidocaine versus peribulbar anesthesia in combined surgery: a randomized clinical trial.

PURPOSE: To compare the efficiency and safety of contact-topical anesthesia versus peribulbar injection anesthesia for phacotrabeculectomy. MATERIALS AND METHODS: A total of 80 patients undergoing combined cataract and glaucoma surgery were randomly allocated to receive either contact or peribulbar anesthesia. No systemic sedatives were used in either group. Patients were asked to rate their pain level on a 5-point scale for 4 periods: during administration of the anesthetic agent; during surgery; immediately after surgery; and 24 hours postoperatively, while the surgeon recorded his subjective assessment of ease of surgery using a standardized template. The patients' general condition during surgery, as well as the results and short-term complications, were assessed. RESULTS: The injected anesthesia group showed higher rates of discomfort and pain, and 37 patients reported pain ranging from mild to severe during anesthetic administration. The difference between groups was statistically significant (P < 0.001). During surgery, there were no differences in vital signs, patients' subjective pain evaluation, or surgeon stress. We found no differences between pain rates after surgery. Complications included prolonged chemosis, and we also noted that conjunctival hemorrhage occurred more frequently in the peribulbar group than in the contact anesthesia group. CONCLUSION: Both anesthetic methods provide high levels of pain control without additional sedation during surgery. The use of contact-topical anesthesia avoids pain and reduces the possibility of complications during administration of anesthetics.

Contact versus peribulbar anaesthesia in trabeculectomy: a prospective randomized clinical study.

PURPOSE: To compare the pre-, intra- and postoperative pain scores and complication rates in trabeculectomy under contact-topical anaesthesia versus peribulbar injection anaesthesia. METHODS: A total of 100 patients selected to undergo primary trabeculectomy were randomly allocated to receive either contact or peribulbar anaesthesia. Patients were asked to rate their pain levels on a 5-point scale for four periods: during the administration of the anaesthetic agent, during surgery, immediately after surgery and 24 hours postoperatively. At the same time, the surgeon was asked to record his subjective assessment of the stress he himself had suffered during the course of the intervention. Surgical parameters, intra- and early postoperative complications were also evaluated. RESULTS: The difference between groups was statistically significant during anaesthetic administration. Six patients who received contact-topical anaesthesia reported mild discomfort during delivery of the anaesthetic agent, while 43 patients complained of mild to severe pain during the injection of bupivacaine (p < 0.001). Thirty-two patients in the contact anaesthesia group and 26 in the injected anaesthesia group reported no pain during surgery (p = 0.127). Only one patient in each group reported mild pain 30 min postoperatively. We found no differences between pain rates after surgery. Complications included prolonged chemosis and we also noted that conjunctival haemorrhage occurred more frequently in the peribulbar group than in the contact anaesthesia group (p = 0.012). CONCLUSION: Both anaesthetic methods provided high levels of pain control without additional sedation during surgery. The use of contact-topical anaesthesia reduces both pain and the possibility of complications during the administration of anaesthetics.