Boston Keratoprosthesis type 1 (KPro) without contact lens wearing in end-stage corneal disease: The APEC experience.

PURPOSE: To report the visual outcomes and survival analysis of keratoprosthesis without contact lens wearing in a tertiary eye care hospital in Mexico City, Asociación Para Evitar La Ceguera (APEC, Coyoacán, México). DESIGN: Retrospective cohort with survival analysis. PARTICIPANTS: Twenty-three eyes (22 patients) received KPro type 1 between 2015 and 2020 with a follow-up time of three years. METHODS: We included analyzed data about past medical history, preoperative diagnosis, best-spectacle visual acuity (BSCVA), postoperative complications and retention rate. Univariate, bivariate and survival analysis were performed and reported. RESULTS: The mean age was 58 ± 13.5 years (SD). 60.86% were male patients (14 eyes). Twelve-eyes (52%) achieved a BSCVA of 20/200 or better in the first and second year of follow-up. At 3 years, only 35% achieved 20/200 or better (BSCVA). Retention rate of Boston type 1 KPro was 87% (20 eyes) at 3 years follow-up. The most common complication was retroprosthetic membrane (RPM) which occurred in 9 eyes (39.1%), followed by corneal melting in 7 eyes (30.4%). CONCLUSIONS: We report the results of a retrospective cohort of twenty-three eyes (22 patients) who were implanted with a Boston type 1 KPro without contact lens wearing to treat corneal blindness. BSCVA improved significantly in most patients achieving 20/200 or better at the 2-year follow-up. Retention rate was 87%, with the presence of RPM as the most common complication.

Correlation and Level of Agreement between the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires: A Survey-Based Study.

PURPOSE: The Ocular Surface Disease Index (OSDI) is the most frequently used dry eye disease (DED) questionnaire, and the Symptom Assessment iN Dry Eye (SANDE) is the simplest and quickest to apply. We analyze the correlation and level of agreement between these two questionnaires in a large DED heterogeneous population to evaluate their performance and potential interchangeability. METHODS: Prospective, multicenter longitudinal survey-based study performed on patients diagnosed with DED by 99 ophthalmologists from 20/32 Mexican states. Questionnaires were applied in two consecutive visits to analyze the correlation between OSDI and SANDE to evaluate patients with DED clinically. Level of agreement was evaluated with Bland-Altman analysis, and internal consistency of instruments was evaluated individually and combined with Cronbach's alpha index. RESULTS: 3421 patients studied: 1996 (58.3%) women and 1425 (41.7%) men, aged 49.5 ± 15.4 years; 995 (29.1%) patients had aqueous-deficient, 1086 (31.7%) evaporative, and 1340 (39.2%) mixed DED subtypes. Normalized baseline scores were 53.7 (OSDI) and 54.1 (SANDE). After 36.3 ± 24.4 days between visits, scores were reduced to 25.2 (OSDI) and 21.8 (SANDE) points (p < .001). A positive correlation between questionnaires was found at baseline (R = 0.592; p < .001), follow-up (R = 0.543; p < .001) and change between visits (R = 0.630; p < .001). Using both questionnaires together improved the overall reliability of symptom evaluation at baseline (α = 0.7), follow-up (α = 0.7), and both (α = 0.7), compared to individual application (OSDI α = 0.5, SANDE α = 0.6)-the same improvements applied to all DED subtypes. Bland-Altman analysis revealed a differential bias of -0.41% at baseline and +3.6% at follow-up visits between OSDI and SANDE. CONCLUSIONS: We validated the correlation (high precision) between questionnaires in a large-scale population, demonstrating improved reliability (high accuracy) in evaluating DED when used together, challenging their interchangeable use. These results open a venue to improve recommendations toward a more precise and accurate diagnostic and therapeutic evaluation of DED by using OSDI and SANDE concurrently.

Cataract surgery in patients with underlying keratoconus: focused review.

An underlying diagnosis of keratoconus (KC) can complicate cataract surgery. In this study, the results of a focused review of the literature pertaining to cataract surgery in patients with KC are detailed. Topics essential for the appropriate management of this patient population are discussed. First, the individual and shared epidemiology and pathophysiology of cataract and KC are reviewed. Then, the theory and approach to intraocular lens power calculation are discussed, highlighting particularities and pitfalls of this exercise when performed in patients with KC. Finally, several special-although not uncommon-management scenarios and questions are addressed, such as surgical planning in cases where corneal stabilization or tissue replacement interventions are also necessitated.

Early keratometric and refractive results after intra-corneal rings surgery in keratoconus patients.

OBJECTIVE: To evaluate early keratometric and refractive results after intra-corneal rings surgery in keratoconus patients. METHOD: 50 eyes of 25 patients with keratoconus within stage 2 and 3, underwent intra-stromal corneal rings surgery by using the femtosecond surgical laser, one month after surgery, corneal keratometries and patient refraction were compared vs pre-operative ones. RESULTS: Mean pre-operative low keratometry was 48.8 ± 3.65 D vs. 46.44 ± 3.65 D post-operative (p < 0.005). Mean pre-operative high keratometry was 53.92 ± 4.50 vs. 49.65 ± 4.15 post-operative (p < 0.005). Mean pre-operative spherical equivalent was -7.39 ± 2.42 D vs. -3.48 ± 2.47 D post-operative (p < 0.005). Mean pre-operative cylinder was -5.65 ± 2.02 D vs. -3.48 ± 2.47 D post-operative (p < 0.005). CONCLUSIONS: Corneal keratometries, spherical equivalent and corneal cylinder, significant decrease at one month after intra-stromal corneal rings surgery in keratoconus patients.

OBJETIVO: Evaluar los resultados queratométricos y refractivos tempranos de pacientes con queratocono operados con anillos intracorneales. MÉTODO: Se evaluaron 50 ojos de 25 pacientes con queratocono de grado 2 o 3, posoperados con colocación de anillos intracorneales mediante el uso de láser de femtosegundos, al mes del posoperatorio, comparando las queratometrías y las refracciones antes y después de la operación. RESULTADOS: El promedio preoperatorio de las queratometrías planas fue de 48.8 ± 3.65 D y en el posoperatorio fue de 46.44 ± 3.65 D (p < 0.005). El promedio preoperatorio de las queratometrías curvas fue de 53.92 ± 4.50 y en el posoperatorio fue de 49.65 ± 4.15 (p < 0.005). El equivalente esférico preoperatorio fue de −7.39 ± 2.42 D y en el posoperatorio fue de −3.48 ± 2.47 D (p < 0.005). El promedio del cilindro preoperatorio fue de −5.65 ± 2.02 D y en el posoperatorio fue de −3.48 ± 2.47 D (p < 0.005). CONCLUSIONES: La colocación de anillos intracorneales reduce de forma significativa tanto las queratometrías como los equivalentes esféricos y el astigmatismo en pacientes con queratocono en forma temprana.

A Practical Approach to Severity Classification and Treatment of Dry Eye Disease: A Proposal from the Mexican Dry Eye Disease Expert Panel.

Dry eye disease (DED) has a higher prevalence than many important systemic disorders like cardiovascular disease and diabetes mellitus, representing a significant quality of life burden for the affected patients. It is a common reason for consultation in general eye clinics worldwide. Nowadays, the diagnostic and therapeutic approach at the high corneal and ocular surface specialty level should be reserved for cases of severe and chronic dry eye disease associated with systemic autoimmune diseases or complicated corneal and ocular surface pathologies. In such cases, the diagnostic and therapeutic approach is often complex, elaborate, time-consuming, and costly due to the use of extensive dry eye questionnaires, noninvasive electronic diagnostic equipment, and clinical laboratory and ancillary tests. However, other eye care specialists attend a fair amount of DED cases; therefore, its diagnosis, classification, and management should be simple, practical, achievable, and effective. Considering that many patients attending non-specialized dry eye clinics would benefit from better ophthalmological attention, we decided to elaborate a practical DED classification system based on disease severity to help clinicians discriminate cases needing referral to subspecialty clinics from those they could attend. Additionally, we propose a systematic management approach and general management considerations to improve patients' therapeutic outcomes according to disease severity.

A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study.

PURPOSE: Dry eye disease is characterized by loss of tear film stability. OC-01 (varenicline solution) is a small-molecule nicotinic acetylcholine receptor agonist administered as a nasal spray that stimulates tear production. METHODS: In MYSTIC (NCT03873246) patients aged ≥22 years with dry eye disease were randomized 1:1:1 to OC-01 0.03 mg, OC-01 0.06 mg, or vehicle (n = 41 per group), administered twice daily via intranasal spray, for 12 weeks (84 days). Primary efficacy endpoint was mean change from baseline in anesthetized Schirmer's test score (STS) in study eye at day (D) 84. RESULTS: Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively. A trend toward a higher proportion of patients experiencing ≥10-mm improvement in STS from baseline was observed with OC-01 0.03 mg (36.6%; p > 0.05), and was significant for OC-01 0.06 mg (48.8%; p = 0.024), versus vehicle (24.4%). Non-ocular treatment-emergent adverse events (TEAEs) were reported by 21 patients; the most common was sneezing (OC-01 0.03 mg, 2 [4.9%]; OC-01 0.06 mg, 3 [7.3%]), with similar frequencies between treatment groups. No severe or serious TEAEs were reported. CONCLUSIONS: OC-01 (varenicline solution) nasal spray improved tear production in patients with dry eye disease over a long-term (12-week) period, and represents a receptor neuro-activator with a nasal route of administration that spares the ocular surface to stimulate tear production.

Bilateral Corneal Ectasia 3 Years After Small Incision Lenticule Extraction in a Borderline Case.

PURPOSE: The purpose of this study was to report a case of bilateral ectasia 3 years after small incision lenticule extraction (SMILE) in a patient with normal preoperative topography of the right eye and abnormal topography of the left eye. METHODS: This study was a case report. RESULTS: A 22-year-old man developed bilateral corneal ectasia after SMILE. The preoperative corneal topography of the right eye was unremarkable, with a minimum corneal thickness of 511 µm in the right eye, and the abnormal corneal topography of the left eye revealed a risk factor for developing ectasia, with a minimum corneal thickness of 514 µm in the left eye. The refractive error was -4.50 to 3.50 × 10 degrees in his right eye and -4.25 to 3.50 × 0 degrees in his left eye with a best-corrected visual acuity of 20/20. An uncomplicated SMILE was performed; after his last follow-up visit at 1 month, the patient was lost to follow-up for 3 years. After that time, he presented with visual loss with left predominance. Bilateral ectasia was diagnosed through corneal topography, and crosslinking was performed in both eyes. CONCLUSIONS: There are a very few reports of corneal ectasia after SMILE with normal preoperative topography.

Solid Platelet­rich Plasma Combined with Silicone-hydrogel Soft Contact Lens for Non-healing Corneal Ulcers: A Case Series.

PURPOSE: To present a case series of non-healing corneal ulcers treated by solid activated platelet-rich plasma (PRP) combined with silicone-hydrogel soft contact lens. METHODS: Three eyes from three patients with unresponsive corneal ulcers were included. A clot of PRP was applied directly onto the corneal ulcer and covered with a soft contact lens. The primary outcome was corneal healing. Changes in corneal ulcer area were measured by analyzing slit-lamp photographs taken using ImageJ software. RESULTS: Successful corneal healing was achieved in all patients within two weeks, with no recurrences or signs of infection through the last follow-up. In two of the three cases, treatment was applied twice. CONCLUSIONS: This novel procedure was easy to perform, economically advantageous, and a possible alternative to surgical approaches for enhancing epithelial wound healing in patients with non-healing corneal ulcers. Further prospective and comparative studies are needed to assess the efficacy of this treatment.

In vivo confocal microscopy findings after SMILE refractive surgery technique.

OBJECTIVE: To evaluate confocal microscopy finding after SMILE surgery by in vivo confocal microscopy and stromal lenticule and stromal interface accuracy planed vs measured. METHOD: Thirty eyes of 15 patients were evaluated before and 1 month after SMILE surgery by using confocal microscopy. Cellular morphology was studied. Planed stromal lenticule thickness was compared vs measured stromal lenticule thickness after surgery by comparing the total stromal corneal thickness before vs after surgery. Stromal corneal interface was evaluated and depth of this planed interface was compared vs measured post-surgery interface depth. RESULTS: Sub-epithelial nerve plexus was absent at 1 month after surgery. Activated keratocytes were found before and after stromal corneal interface depth. There was not statistical significant difference between mean planed stromal lenticule vs. post-surgery measured (102.3 ± 25.7 vs. 104.2 ± 29.9 mm; p = 0.73). There was not statistical significant difference between mean planed stromal interface depth vs. post-surgical measured (113.7 ± 8.2 vs. 120.5 ± 17.3 mm; p = 0.058). CONCLUSIONS: Confocal microscopy is useful to evaluate changes after SMILE surgery; lenticule thickness and stromal interface depth are exact.

OBJETIVO: Evaluar los hallazgos mediante microscopía confocal in vivo de pacientes operados de cirugía SMILE, la exactitud del lentículo estromal y la profundidad de la interfaz estromal planeados versus medidos. MÉTODO: Treinta ojos de 15 pacientes operados de SMILE se estudiaron mediante microscopía confocal antes y al mes de la cirugía. Se evaluaron la morfología celular, el espesor del lentículo estromal planeado versus el medido en el posoperatorio mediante la diferencia entre el espesor estromal preoperatorio y el postoperatorio, así como la interfaz estromal, y se comparó la profundidad de esta interfaz estromal planeada con la medida en el posoperatorio. RESULTADOS: Se observó la ausencia del plexo nervioso subepitelial al mes del posoperatorio y una activación de queratocitos anterior y posterior a la profundidad de la interfaz estromal. No hubo diferencia en el lentículo estromal planeado versus el medido en el posoperatorio (102.3 ± 25.7 vs. 104.2 ± 29.9 mm; p = 0.73). No hubo diferencia entre la profundidad de la interfaz estromal planeada y medida (113.7 ± 8.2 vs. 120.5 ± 17.3 mm; p = 0.058). CONCLUSIONES: Tras la cirugía SMILE se pueden evaluar los cambios mediante microscopía confocal; el espesor del lentículo y la profundidad de la interfaz son exactos.

Polymicrobial Keratitis: Risk Factors, Clinical Characteristics, Bacterial Profile, and Antimicrobial Resistance.

OBJECTIVE: To describe clinical characteristics, complications, and the most prevalent microorganisms causing polymicrobial keratitis and their antibiotic sensitivities. METHODS: A cross-sectional study including a consecutive analysis of patient's records with a diagnosis of bacterial keratitis with a positive culture and antibiogram report were included. Patients were grouped into those having monomicrobial and polymicrobial infection. Features studied included demographic and clinical characteristics, risk factors, Gram stain, cultures, and antibiotic sensitivity. RESULTS: We included 656 patients; in 31.5% more than one microorganism was found. Seven hundred and twenty-three gram-positive bacteria were isolated, and 336 (46.5%) had polymicrobial keratitis. One hundred sixty-one gram-negative bacteria were isolated, and 99 (61.5%) from polymicrobial keratitis. Fourteen (0.60%) patients presented ring infiltrate, and 10 (71.42%) of those patients had polymicrobial keratitis (X2 10.654, P=0.001). Multivariate analysis showed that patients with history of contact lens use (odds ratio [OR] of 1.78, P=0.042), coexistent autoimmune disease (OR 4.64, P=0.03), irregular edges of the infiltrate (OR 2.06, P=0.005), and ring infiltrate (OR 6.034, P=0.005) have a higher risk for developing polymicrobial infection. In the polymicrobial group, gram-positive and gram-negative organisms showed a high sensitivity to Netilmicin. CONCLUSIONS: We found a high incidence of polymicrobial keratitis. Our results suggest that it should be suspected in patients with a history of contact lens use, coexistent autoimmune disease, infiltrates with indistinct edges, and ring infiltrates. Sensitivities to moxifloxacin are lower than those reported in previous studies, but sensitivity to Netilmicin is higher.

In Vivo Confocal Microscopy Findings in Bowman Layer Transplantation.

PURPOSE: To report the in vivo confocal microscopy (IVCM) findings of a case who underwent femtosecond laser-assisted Bowman layer transplantation (BLT). METHODS: This is a case report. RESULTS: In a 25-year-old man with previous diagnosis of keratoconus in whom a BLT was performed using the femtosecond laser-assisted technique, IVCM (Confoscan 4; Fortune Technologies, Vigonza, Italy) was performed 3 months after surgery, obtaining a sequence of 4 digitalized images of the total thickness of the cornea, from the epithelium to the endothelium, and then backward. The images were analyzed with the Navis v. 3.5.0. system (NIDEK, Multi-Instrument Diagnostic System, Japan). In the anterior stroma, before arriving to the graft interphase, activated keratocytes could be observed with higher reflectivity. In this first image of the anterior interphase, a homogenous hyporreflective image could be observed. In the interior of the graft, no keratocytes were found and some hyperreflective particles were present. In addition to the anterior, the posterior interphase presented bright particles. CONCLUSIONS: This is the first report that documents a BLT using IVCM.

Photoactivated Chromophore for Keratitis-Corneal Collagen Cross-Linking (PACK-CXL) Improves Outcomes of Treatment-Resistant Infectious Keratitis.

PURPOSE: To investigate the efficacy of photoactivated chromophore corneal collagen cross-linking (PACK)-CXL in the management of treatment-resistant infectious keratitis. DESIGN: Observational cohort study. PARTICIPANTS: Forty-two eyes from 41 patients with treatment-resistant infectious keratitis. METHODS: Eyes underwent PACK-CXL treatment with the Dresden modified protocol in addition to standard antimicrobial therapy. The primary endpoint was the size of the corneal ulcer. Descriptive statistics, Wilcoxon rank test, McNemar test and Spearman correlation coefficient were used for statistical analysis, and p values lower than 0.05 were considered statistically significant. RESULTS: Success rate at third postoperative month was of 90.5%. Statistical analyses showed a significant effect of (PACK)­CXL with standard antimicrobial therapy to reduce corneal ulcer size (p=0.031). CONCLUSION: As adjuvant therapy to standard antimicrobial treatment, PACK-CXL improves the outcomes in patients with treatment-resistant corneal ulcers.

Whole exome profiling and mutational analysis of Ocular Surface Squamous Neoplasia.

PURPOSE: To determine genetic mutational profiles in patients with Ocular Surface Squamous Neoplasia (OSSN) using whole exome sequencing. METHODS: Prospective, case-series study. Patient recruitment was conducted in a single tertiary referral center from April to September 2017. Specimens were obtained by incisional biopsies of tumors from ten eyes with histopathologic confirmation of OSSN. DNA whole exome sequencing and mutation analysis were performed. RESULTS: Ten patients with clinically-diagnosed OSSN underwent DNA whole exome sequencing analysis. Deleterious mutations in 305 genes known to drive tumor development and progression were found. These mutations centered around two main pathways: DNA repair/cell cycle and development/growth. All ten samples had at least one mutation in a DNA repair/cell cycle gene and all but one sample had one in a development/growth gene. The most common mutation was found in TP53 and HGF (both present in 50% of cases) and mutually exclusive mutations were found in BRCA1 and BRCA2 (50% of cases). Mutations in APC, MSH6, PDGFRA, and PTCH1 were found in 40% of cases. Global mutation analysis identified ultraviolet induced radiation as the only mutational signature present in the dataset. CONCLUSIONS: Mutations found in samples from patients with OSSN are mainly induced by ultraviolet radiation and occur within two main pathways related to DNA repair/cell cycle and development/growth. There are many clinically available drugs and several others being evaluated in clinical trials that target the genes found mutated in this study, offering new therapeutic options for OSSN.

Visual and Anatomic Results After Sole Full-Thickness Sutures for Acute Corneal Hydrops.

PURPOSE: To determine whether sole full-thickness corneal sutures are a feasible treatment for acute corneal hydrops, and if so, report the anatomic and visual results of this technique. METHODS: A retrospective case series was carried out in 17 patients, all of whom received sole full-thickness sutures as a treatment for corneal hydrops. RESULTS: The included patients reported symptom commencement a median of 15 days before the surgical intervention. The patients' median preoperative corneal pachymetry was 1235 µm, whereas 1 month after the surgery, the median corneal thickness was 830 µm, and after 3 months, it was 502 µm (P < 0001). Preoperative best corrected visual acuity (BCVA) was 1.40 LogMAR and a final postsurgical BCVA of 1.00 LogMAR after 3 months of the follow-up (P < 0001). Deep neovascularization was present in 3 patients (17.6%); none of the patients developed cataract formations or pupillary blocks. CONCLUSIONS: Given the improvement of the corneal pachymetry and the BCVA, sole full-thickness sutures seem to be a feasible surgical option to treat severe acute corneal hydrops.

Comparison of meibomian gland loss area measurements between two computer programs and intra-inter-observer agreement.

BACKGROUND: Meibography is a diagnostic test that allows in vivo evaluation of meibomian gland (MG). Nowadays, it is unknown whether the two available computer programs are equivalent to evaluate the glandular loss area. METHODS: This is a prospective, longitudinal, and observational study. A random selection of meibography photographs from healthy patients from the ocular surface clinic at Destellos de Luz foundation is made. The upper eyelid images were taken with the Antares® meibography (CSO, Florence, Italy); they were classified in five sessions with a week of separation between each measurement by an expert observer for each program, Phoenix (MAGL) and ImageJ (LAGB). An analysis of the meibomian gland loss area was performed, calculating it semiautomatically with Phoenix and manually with ImageJ. Intra-observer agreement was assessed through an intra-class correlation coefficient and the mean of standard deviations within subjects. Comparison between the two computational programs MG loss was made trough a nonparametric test. RESULTS: Fifty-four images from x patients (n, 67.3% female) were analyzed. The limits of concordance analysis between the two programs showed a range between - 18.55 and 9.14%. The mean MG loss area through ImageJ by observer 1 was 27.91 ± 14.82% (IC 95% 23.87 to 31.96), and that by observer 2 was 29.05 ± 15.17% (95% CI 24.91 to 33.19). The mean MG loss area through Phoenix by observer 1 was 24.48 ± 13.97% (IC 95% 20.67 to 28.29), and that by observer 2 was 24.93 ± 12.70% (95% CI 21.46, 28.40) CONCLUSIONS: The comparison of the measurement of meibomian gland loss with both programs showed a statistically significant difference. Intra-observer repeatability and inter-observer repeatability were good, with no clinical or statistical difference.

Assessment of Postural Compliance After Pneumatic Retinopexy.

PURPOSE: We describe the functioning of a novel device, aimed to assess patient head position after a pneumatic retinopexy. METHODS: We enrolled patients with the clinical diagnosis of rhegmatogenous retinal detachment. All patients were asked to wear a specially designed headband with a monitoring device composed of an accelerometer, gyroscope, and magnetometer, powered by a 3.7V lithium battery. Every 200 ms, the device measured neck flexion and extension, left and right rotation, and left and right flexion. Patients were asked to come back the next morning for follow-up and headband retrieving. RESULTS: The device was worn an average of 19.17 ± 2.1 hours and performed a mean number of 57,670 ± 8663 measurements without power failures or program errors. An acceptable head position was kept for a mean of 3.33 ± 1.8 hours. The hardest axis to maintain was the right and left flexion of the neck (5.5 ± 2.54 hours of acceptable positioning). CONCLUSION: Real-time monitoring of patient head position after a vitreoretinal procedure is feasible. Maintaining a fixed head position for more than 5 consecutive hours is difficult to achieve and physicians should consider this difficulty when planning treatment. TRANSLATIONAL RELEVANCE: In addition to a significant improvement to the basic design of similar devices, our device allows for assessment of patient adherence to postoperative instructions objectively for the first time to our knowledge. This information could be used in the future to elaborate more detailed position nomograms to improve outcomes.

Bowman layer transplantation using a femtosecond laser.

We describe a variation of the original manual Bowman layer transplantation technique. After the isolation of the graft, a stromal pocket is created using a femtosecond laser. With the use of this technology, which entails preservation of the conjunctiva and the non-use of sutures, we avoid the scleral approach. The femtosecond laser proved to be a feasible surgical support of this technique.