Eye & Contact Lens-Science and Clinical Practice最新文献

Abstract: The Food and Drug Administration and the Federal Trade Commission influence the contact lens (CL) market, with the Food and Drug Administration regulating CLs as medical devices and the Federal Trade Commission dictating how they are prescribed and sold. Legislative oversight came to the forefront in 2004, when the Contact Lens Rule was introduced, drastically changing how CLs are prescribed and distributed. This article examines the evolution of CL regulations over the past two decades and discusses how regulation, such as allowing passive verification, has shaped the current and evolving CL market. We also explore how related products (decorative CLs, artificial tears) are regulated and compare US regulations with those abroad. Finally, we discuss how future technological advancements, including artificial intelligence, promise to change the CL industry and its regulation worldwide.

Objective: To review the current literature describing corneal changes observed with orthokeratology (ortho-k) use and to formulate preliminary recommendations for these patients seeking corneal refractive surgery.

Methods: The literature search was conducted through the PubMed, Scopus, and Ovid databases through June 4, 2024, for articles regarding corneal physiological, tomographic, and biomechanical changes secondary to ortho-k use.

Results: Forty-one articles were found describing several changes associated with ortho-k use, including higher corneal staining, central corneal epithelial thinning and midperipheral thickening, increased higher-order aberrations, decreased contrast sensitivity, reduced corneal hysteresis and corneal resistance factor, and alterations in the tear proteome. The majority of these parameters returned to baseline after ortho-k lens discontinuation, with timing potentially dependent on the amount of myopic correction, duration of ortho-k use, and age of lens fitting.

Conclusions: Despite the paucity of articles describing prior ortho-k patients undergoing corneal refractive surgery, it is evident that ortho-k use may potentially cause various corneal physiological, tomographic, and biomechanical changes in patients. Therefore, clinicians are advised to serially monitor ortho-k patients' refraction, tomography, pachymetry, and corneal biomechanics until stability is achieved before considering surgery.

Objectives: Corneal thinning and perforation are ocular emergencies necessitating urgent intervention to prevent visual impairment or enucleation. Cyanoacrylate tissue adhesive is frequently used to maintain globe integrity in these cases. However, gaps remain in understanding the outcomes of corneal gluing and the factors influencing its efficacy. This case series evaluates the clinical characteristics and outcomes of glue application in corneal thinning and perforation.

Methods: A retrospective chart review was conducted on patients treated for corneal thinning and perforation at the University of Florida between January 2012 and May 2023. Demographic data, clinical history, glue application details, and posttreatment outcomes were collected and analyzed.

Results: The study included 128 eyes from 125 subjects. Corneal perforation was found in 71 eyes (55.5%), mostly centrally (49.2%). The leading cause of perforation/thinning was microbial infection (45.3%). The average number of glue applications per eye was 1.66. Within 1 month, 23 patients (18.0%) required only glue reapplication, 37 (28.9%) required surgical intervention (regardless of glue reapplication), and 68 (53.1%) required no further treatment. Factors significantly linked to gluing failure (requiring surgery within 1 month) in univariate analysis included large perforation size, microbial infection, ocular surface disorder, single glue application, and indirect application via sterile drape. Multivariate analysis showed that only large perforation size was significantly associated with gluing failure.

Conclusion: Corneal glue application is an effective temporizing measure for corneal thinning and perforation, with multiple applications potentially providing added stability to the globe. However, the need for surgical intervention is high.

Objective: To review the literature focusing on the effectiveness of amniotic membrane extract eye drops (AMEDs) in the treatment of ocular surface diseases.

Methods: PubMed/MEDLINE, Scopus, and CENTRAL databases were searched until March 4, 2024. Overall, we identified 1,121 studies, 26 of which were selected for a full-text review. Twelve studies met the inclusion criteria and were analyzed for clinical improvements, time to resolution of corneal staining, adverse events, and preparation methods. Strength of clinical data was graded according to the Oxford Center for Evidence-Based Medicine.

Results: Overall, AMED compounds were used in 296 eyes of 205 patients. Fifty-nine percent of eyes were treated for dry eye disease, 23% for an epithelial defect, and the rest (18%) for other corneal wound healing disorders. Three main types of eye drops preparation were described, that is, lyophilized, homogenized, and fresh AMED. Although the methods of outcome reporting were heterogeneous, all included studies showed various grades of improvement in both signs and symptoms. The overall incidence of ocular side effects was 2.3%.

Conclusions: Despite the suboptimal quality of evidence, overall, the available literature suggests that AMED is a valuable tool in the treatment of ocular surface disorders.

Objective: The purpose of this observational study was to characterize the microorganisms colonizing punctal plugs and intracanalicular stents.

Methods: Devices were removed from participants who previously underwent placement of punctal plugs for tear insufficiency and lacrimal stents for dacryocystorhinostomy and canalicular reconstruction procedures. After removal of the devices, they were cultured for organisms both with and without sonication to loosen any biofilms or adherent microorganisms. Primary outcome measures included culture positivity, identification of isolated microorganisms, recovery of microorganisms from culture after sonication, and clinical evidence of ocular infection.

Results: There were no cases of clinical infection. A total of 181 specimens were processed (174 punctal plugs, seven intracanalicular stents), of which 98 (54%) were culture positive. Of the punctal plugs, 92 (52.9%) were culture positive, including 42 with a single organism isolated, whereas 22 yielded two organisms, 7 yielded three organisms, and the remaining 21 yielded a polymicrobial culture with four or more organisms. The most common isolates from punctal plugs were coagulase negative staphylococci (27.6%), diphtheroids (16.4%), and streptococcus viridans (10.2%). Those plugs with polymicrobial culture results grew a mixture of organisms most consistent with skin or upper respiratory flora. Of the intracanalicular stents, 6 (85.6%) were culture positive.

Conclusions: Punctal plugs and intracanalicular devices can become colonized with bacteria composed of oropharyngeal flora, skin flora, and other rare but potentially significant pathogens.

Purpose: The aim of the study was to investigate the corneal and anterior segment characteristics in pseudoexfoliation syndrome (PXS), depending on the severity of the disease.

Materials and methods: This cross-sectional study was conducted at a tertiary care hospital, in the ophthalmology department, in Turkey. Pseudoexfoliation syndrome group was classified into three groups. Pseudoexfoliative material on the part of the pupillary border was classified as group 1, on the entire pupillary border was classified as group 2, and pseudoexfoliative material on the entire pupillary border and iris surface was classified as group 3. The control group was composed of age and gender-matched individuals who had undergone a completely normal ophthalmologic examination. Scheimpflug tomography was performed to record tomographical data.

Results: The PXS groups 1, 2, and 3, along with the control group, consist of 29, 32, 33, and 42 participants, respectively. There was no significant difference in age-gender distribution between patients and the control group ( P >0.05). Group 3 showed significant differences in central corneal thickness compared with the control group ( P =0.001). In addition, anterior chamber angle was found to be significantly lower in group 3 than the control group ( P <0.001). In corneal densitometry (CD) values, significant increases compared with the control group were observed in groups 2 and 3 across all anterior annuli ( P <0.001). In group 1, significant increases observed in the anterior 6-10 mm and 10-12 mm annuli ( P <0.001). In the middle 6-10 mm annuluses, only group 3 showed a significant increase compared with the control group ( P <0.001). In the posterior 0-2, 2-6, and 6-10 mm annuli, significant increases compared with the control were observed only in groups 2 and 3 ( P =0.001, P =0.001, P <0.001, respectively).

Conclusions: Corneal densitometry values, even without an increase in intraocular pressure, have a tendency to increase in PXS depending on the severity of the disease. While minimal changes were observed in the middle layer, it was particularly noted that the effects of the disease were more prominent in the peripheral cornea.

Purpose: Limited information exists on the possible effects of ethnicity on corneal endothelial cell parameters and their changes during cataract surgery. Thus, we evaluated corneal endothelial cell density (ECD) and endothelial cell loss (ECL) during surgery for senile cataract in Hispanic and non-Hispanic White adults.

Methods: This retrospective study included 312 eyes of 227 patients ≥50 years who underwent phacoemulsification with intraocular lens implantation for senile cataract. Preoperatively and 1 to 2 months after surgery, specular microscopy was performed to measure ECD, coefficient of variation (CV), and hexagonal cell percentage (HEX). Regression analysis was used to compare baseline values as well as surgery-related changes in corneal endothelial cell parameters between Hispanic and non-Hispanic patients considering demographics, biometric parameters, and intraoperative cumulative dissipated energy (CDE).

Results: There were 109 Hispanics and 118 non-Hispanics. Anterior chamber depth (ACD) was significantly lower in Hispanics (3.12±0.36 mm) compared with non-Hispanics (3.25±0.37 mm, P =0.009). There were no significant differences in baseline ECD between Hispanics (2,547±365 cells/mm 2 ) and non-Hispanics (2,483±380 cells/mm 2 , P =0.17). There were also no significant differences in ECL (16.8%±17.0% vs. 17.4%±18.1%, P =0.46), increase in CV (3.8%±20.7% vs. 1.5%±21.6%, P =0.51), and decrease in HEX (-2.7%±8.5% vs. -1.8%±7.0%, P =0.33) between these two groups. Regression analysis showed that ECL was associated with a shallower ACD ( P =0.003), a higher CDE ( P <0.001), but not with ethnicity ( P =0.46).

Conclusion: There are no significant differences in ECD and ECL between Hispanics and non-Hispanics undergoing cataract surgery. Although Hispanics have a shallower ACD, the ethnic difference seems to be clinically insignificant.

Abstract: Bruton tyrosine kinase (BTK) inhibitors have become an important therapeutic option in treating B-cell malignancies including non-Hodgkin lymphoma and chronic lymphocytic leukemia. However, a noted morbidity associated with their use is the potential for the development of second primary malignancy related to immunomodulation. In this case, we report a second primary malignancy of ocular surface squamous neoplasia (OSSN) owing to BTK therapy. The OSSN was successfully treated and has been monitored without recurrence. To our knowledge, this is the first case of OSSN secondary to BTK therapy.

Purpose: To assess risk factors for contact lens (CL)-related bacterial keratitis, cases and high-risk controls were enrolled. Using high-risk controls can help elucidate whether certain CL types or modalities are attributable to disease burden if risky wear patterns are similar between the cases and controls. This analysis identified whether such CL factors were associated with the occurrence of bacterial keratitis. In addition, a case-only analysis determined CL factors associated with severe disease.

Methods: From 2018 to 2021, 158 controls were enrolled at University Hospitals of Cleveland Eye Institute, and 153 bacterial keratitis cases were enrolled across 14 sites in the United States. Cases were soft CL wearers with either culture-proven bacterial keratitis or a corneal infiltrate with an overlying epithelial defect within the central 4 mm of the cornea, uveitis, or significant pain. Fungal, protozoan, or nonsoft CL wear-related microbial keratitis cases were excluded. Controls were recruited from high-risk CL wearers with no history of disease. All participants completed a questionnaire related to demographics, type of CL used, wearing schedule, lens handling practices, and storage case handling. Cases with ulcer/infiltrate size ≥2 mm in size, presence of hypopyon, or had fortified antibiotics prescribed were classified as severe keratitis. Univariate and multivariable logistic regression was used to assess association of CL variables with the occurrence of bacterial keratitis as well as occurrence of severe disease among the cases only.

Results: Compared with the control cohort, cases were older (mean age 45.6 vs. 38.9 years), had more males (42.5% vs. 23.6%), and had more current or former smokers (41.7% vs. 12.9%). There were no significant associations between CL material (silicone hydrogel vs. not) or CL type (daily disposable vs. reusable) and occurrence of bacterial keratitis. More than two-thirds (67.3%) of cases were classified as severe. Among cases only, univariate analyses found current smokers to have increased risk of severe disease (OR=2.87; 95% CI 1.13-7.26, P =0.03). Adjusting for age, sex, and smoking among the cases only, daily disposable lenses were protective against severe disease (OR=0.32; 95% CI 0.11-0.89, P =0.03). Reusable lenses increased risk of severe microbial keratitis between 3.0- and 4.4-fold compared with compliant daily disposability.

Discussion/conclusion: Compared with a high-risk control cohort, no specific lens factors were associated with occurrence of CL-associated bacterial keratitis. Among cases only, current smokers and patients wearing reusable lenses are at increased risk of severe keratitis. Daily disposable lenses were protective even when noncompliance to daily disposability was considered.

Objective: To assess keratoconus (KC) progression following the implant of intrastromal corneal ring segments (ICRSs) in young patients.

Materials and methods: Retrospective, longitudinal, observational, controlled nonrandomized case series study. Keratoconus patients aged 25 years or younger who underwent uneventful ICRS surgery and completed at least 3 years of follow-up were enrolled. Controls were of similar age and treatment-naive patients with KC. The following Pentacam imaging (Oculus, Wetzlar, Germany) data were analyzed: keratometric (maximum, in-flattest meridian, in-steepest meridian, and mean), aberrometric (higher-order aberrations and coma), pachymetric (thinnest corneal thickness), and elevation (maximum posterior elevation). The main outcome measure was KC progression.

Results: The study sample comprised 20 eyes of 18 cases (age 20.20 ± 3.70 years, nine right eyes, 14 male patients) and 30 eyes of 24 controls (age 20.80 ± 3.20 years, 15 right eyes, 21 male patients). The mean follow-up duration was 4.90 ± 1.70 years (range 3-8 years) for cases and 4.50 ± 1.40 years (range 3-8 years) for controls. Four cases and two controls met criteria for KC progression.

Conclusions: Intrastromal corneal ring segments did not have significant impact on KC progression in the cohort.