Prevalence and risk factors of eye diseases in adult patients with obstructive sleep apnoea: results from the SLE.E.P.Y cohort study.

OBJECTIVES: To assess the occurrence of glaucoma, eyelid, corneal and macular disorders in a cohort of patients with obstructive sleep apnoea (OSA) diagnosed by overnight polysomnography and to investigate into the risk factors for the above eye diseases (EDs). DESIGN: Cross-sectional cohort study between 2014 and 2015. SETTING: Unit of Respiratory Medicine and Eye Clinic of the University of Verona. PARTICIPANTS: 431 consecutive patients were considered eligible. Of these, 87 declined to participate, 35 were untraceable and 13 were deceased. INTERVENTIONS: A complete ophthalmic evaluation of both eyes for each patient. PRIMARY AND SECONDARY OUTCOME MEASURES: Best-corrected distance visual acuity, intraocular pressure, corneal, macular and optic nerve optical coherence tomography, ocular aberrometry, optic nerve laser polarimetry, visual field test, and eyelid examination. RESULTS: 296 patients aged 64.5±12.8 years, 23% female and 77% male, underwent ophthalmic examination. There was 56% (n=166) prevalence of eyelid disorders, 27% (n=80) of corneal disorders, 13% (n=39) of macular disorders and 11% (n=33) of glaucoma. Advancing age was not associated with the severity of OSA, while significant differences were found for gender, body mass index, Oxygen Desaturation Index, smoking habit, hypertension and diabetes. Severe OSA was significantly associated with glaucoma (OR, 95% CI 1.05 to 5.93, p=0.037). CONCLUSIONS: EDs were more prevalent in our patinets with OSA than in the general population. Severe Apnoea/Hypopnoea Index level seemed to play a role as risk factor only for glaucoma.

Safety outcomes and long-term effectiveness of ex vivo autologous cultured limbal epithelial transplantation for limbal stem cell deficiency.

PURPOSE: To evaluate the safety and effectiveness of ex vivo autologous cultured limbal stem cell transplantation (CLET). METHODS: We reviewed the clinical records of 59 consecutive patients treated with 65 CLETs. Efficacy was graded 1 year after surgery as successful, partially successful or failed. A safety analysis was performed considering side effects and complications that were recorded during the first year after CLET and those reported later than 1 year, including the events related to subsequent treatments. RESULTS: The mean post-CLET follow-up was 6.0±4.1 years. 69% of CLETs had either one or more adverse events (AEs), or adverse drug reactions (ADRs), within 1 year of surgery, with inflammation being the most common (42%), followed by corneal epithelium defects/disepithelialisation (31%), and blood coagula under the fibrin (24%). One year after surgery, 41% of the 59 primary CLET procedures were successful, 39% partially successful and 20% failed. The most common ADRs recorded for the primary unsuccessful CLETs were ulcerative keratitis, melting/perforation, and epithelial defects/disepithelialisation. Six failed CLETs required reconstructive penetrating keratoplasty (PK). Among CLETs with a favourable outcome, 13 underwent corrective PK (mean 4.8±3.4 years), and thereafter seven eyes maintained integrity of the corneal epithelium, five showed corneal surface failure, and one had recurrent epithelial defects. Corneal graft rejection episodes were reported in 71% and 58% of patients following corrective or reconstructive PK, respectively. Seven primary CLETs with a favourable outcome worsened thereafter, and the overall 3-year long-term effectiveness was 68%. CONCLUSIONS: This study addresses important issues regarding possible risks associated with disarray of the ocular surface homeostasis following autologous CLET in patients with limbal stem cell deficiency, despite the fact that the majority of patients experienced a favourable long-term benefit.

Refractive outcomes of penetrating keratoplasty and deep anterior lamellar keratoplasty in fellow eyes for keratoconus.

PURPOSE: To compare the refractive outcomes following penetrating keratoplasty and deep anterior lamellar keratoplasty in fellow eyes in patients with keratoconus. METHODS: This is an observational retrospective review of consecutive patients with keratoconus first managed with penetrating keratoplasty in one eye and then with lamellar keratoplasty in the fellow eye, between 2002 and 2007. Data collection was based on patients' hospital records. Information related to assessment before surgery and at 1, 3, 6, 12, 24, and 48 months after keratoplasty were retrieved and considered in the analysis. Clinical evaluations included patients' medical histories and diagnosis of keratoconus, uncorrected and best corrected visual acuity, spherical equivalent, refractive cylinder, topographic cylinder, and high-order aberrations, complications, and adverse reactions. Data on contrast sensitivity, central corneal thickness, and central residual bed thickness (only for lamellar keratoplasty) were retrieved from anterior segment optical coherence tomography observation performed at 48 months. RESULTS: Sixteen patients (32 eyes), 7 males and 9 females, were included in the analyses. After 4 years from transplantation, at the end of follow-up, no statistically significant differences were found in visual acuity and refractive measures between the two keratoplasties. Perforating keratoplasty showed significant differences for contrast sensitivity at 6 cpd with maximum glare (p = 0.026) and without glare (p = 0.015). Deep anterior lamellar keratoplasty showed a negative correlation between central residual bed thickness and best corrected visual acuity (R = -0.414, p < 0.001). CONCLUSIONS: The manual pre-descemetic deep anterior lamellar keratoplasty used in this study showed refractive and visual results comparable to those obtained with penetrating keratoplasty. Such results indicated that leaving healthy stroma attached to Descemet's membrane does not compromise the clinical outcome in the short and long term after surgery.

In Vivo Confocal Microscopy 1 Year after Autologous Cultured Limbal Stem Cell Grafts.

PURPOSE: To correlate clinical, impression cytologic, and in vivo confocal microscopy findings on the corneal surface after cultured limbal stem cell transplantation. DESIGN: Prospective, interventional, noncomparative, masked case series. PARTICIPANTS: Thirteen patients with limbal stem cell deficiency after unilateral (9 eyes) or bilateral (2 eyes) chemical burn, liquid nitrogen injury (1 eye), or herpes simplex virus infection (1 eye). METHODS: Limbal cells were harvested from healthy or less affected eyes, cultured on 3T3 cells and fibrin glue, and transplanted to the patient's injured eye. Patients underwent clinical examination and impression cytologic examination of the central cornea before and 1 year after intervention. In vivo confocal microscopy scans were obtained in all corneal quadrants after 1 year. The interexamination agreement was established by calculation of the Cohen's κ coefficient. MAIN OUTCOME MEASURES: Results of surgery were assessed considering clinical signs (successful: restoration of transparent, avascular, and stable corneal epithelium without neovascularization in central corneal surface; partially successful: recurrence of superficial neovascularization; failed: recurrent epithelial defects, pannus, and inflammation), phenotype of cells covering the corneal surface (conjunctivalized corneal surface: cytokeratin 12 [cK12]-negative and mucin 1 [MUC1]-positive cells; mixed epithelium: cK12-positive and MUC1-positive cells; corneal epithelium: cK12-positive and MUC1-negative cells), and cell morphologic features (corneal epithelium: multilayered polygonal and flat cells with hyperreflective nuclei; conjunctival epithelium: stratified cuboidal or polygonal cells, hyperreflective cytoplasm, and barely defined borders; epithelial transition: transition of epithelial cells from the cornea to the conjunctiva over the corneal surface). RESULTS: We found a moderate to substantial degree of concordance between confocal microscopy and clinical evaluation (κ = 0.768) and between confocal microscopy and impression cytologic analysis (κ = 0.629). Confocal microscopy showed that 46.2% of patients exhibited corneal epithelium in the central and peripheral cornea, 30.8% showed an irregular mixed corneal and conjunctival epithelium, and 23.0% showed conjunctival epithelium. Palisades of Vogt were absent in all (100.0%) patients, and the cornea-conjunctiva epithelial transition localized approximately 1 mm internally on the cornea. CONCLUSIONS: Confocal microscopy provides objective measures of the corneal epithelium and may significantly improve the evaluation of outcomes after cultured limbal stem cell graft.

Long-term visual function and patient satisfaction after bilateral implantation and combination of two similar multifocal IOLs.

PURPOSE: To evaluate the visual outcome, spectacle independence, and patient satisfaction after implantation of two Acrysof ReSTOR (Alcon Laboratories, Inc., Fort Worth, TX) intraocular lenses (IOLs) with different addition power or their combination in both eyes. METHODS: One hundred twenty eyes of 60 patients with bilateral multifocal IOL implantation were divided into three groups of 20 consecutive patients each: the SV25T0 (the T0 group), the SN6AD1 (the D1 group), or a combination of both the SN6AD1 and SV25T0 (the combined group). Patients were observed 18 months postoperatively for visual acuity (40, 50, and 60 cm, and 4 m), defocus curves (range: +1.0 to -4.0 diopters), and contrast sensitivity. Quality of vision, patient satisfaction, and spectacle independence were evaluated by the National Eye Institute Refractive Error Quality of Life Instrument-42 questionnaire. RESULTS: The D1 group achieved better results for near vision (P < .01), whereas the T0 group achieved better intermediate vision (P = .01). The combined group showed a wider range of spectacle independence at all distances evaluated (P < .05). The contrast sensitivity was similar within the groups. The incidence of glare was lower for the T0 group (P = .054). The combined group had better results in terms of expectation (P = .021) and activity limitation (P = .003). CONCLUSION: Although the bilateral implantation of the same multifocal IOL can maximize the vision for near or intermediate distances, the combination of these IOLs in both eyes can increase the range of spectacle independence without compromising the contrast sensitivity and quality of vision.

Comparison of two multifocal intraocular lens designs that differ only in near add.

PURPOSE: To evaluate monocular functional outcomes after the implantation of the AcrySof ReSTOR SN6AD2 intraocular lens (IOL) (+2.5 diopters [D] near add) (Alcon Laboratories, Inc., Fort Worth, TX) and the AcrySof ReSTOR SN6AD1 IOL (+3.0 D near add) (Alcon Laboratories, Inc.). METHODS: This prospective, comparative, nonrandomized single-blind observational study comprised 62 eyes of 62 patients that underwent phacoemulsification and implantation of a multifocal IOL: SN6AD2 (31 eyes) (+2.5 group) and SN6AD1 (31 eyes) (+3.0 group). Twelve months after surgery, monocular near (30 and 40 cm), intermediate (50, 60, and 70 cm), and distance (4 m) visual acuity were evaluated with the internal root mean square and modulation transfer function. Both parameters were evaluated at the 4- and 6-mm pupil sizes. RESULTS: No statistical differences at 4 m were found between the groups. The +2.5 group obtained better performances at all intermediate distances (50 cm, 0.23 ± 0.14 vs 0.32 ± 0.13; 60 and 70 cm, 0.21 ± 0.10 vs 0.41 ± 0.14 and 0.24 ± 0.10 vs 0.53 ± 0.17, respectively), whereas the near visual acuity was better for the +3.0 group (30 and 40 cm, 0.36 ± 0.18 vs 0.14 ± 0.09 and 0.36 ± 0.19 vs 0.17 ± 0.07, respectively). The root mean square was lower for the +2.5 group compared to the +3.0 group, whereas the modulation transfer function showed overlapping results between the two models. CONCLUSIONS: Both IOL models showed good results in distance vision; the +2.5 D IOL seemed to provide better intermediate vision than the +3.0 D IOL. For near vision, the +3.0 D model performed better than the +2.5 D model.

Higher order aberrations after keratoplasty for keratoconus.

PURPOSE: To compare higher order aberrations (HOAs) caused by the anterior and posterior corneal surfaces after conventional penetrating keratoplasty (PK), deep anterior lamellar keratoplasty (DALK), and automated lamellar therapeutic keratoplasty (ALTK) in patients undergoing corneal transplantation for keratoconus (KC). METHODS: This retrospective, observational, cross-sectional study included one eye of the following subjects: 40 patients with KC, 23 KC patients after PK, 17 KC patients after DALK, 18 KC patients after ALTK, and 38 healthy controls. All underwent imaging with a rotating Scheimpflug camera (at least 6 months after complete suture removal in grafted subjects) to assess the HOAs from the anterior and posterior corneal surfaces within the central 4-mm and 6-mm zones. The conversion of the corneal elevation profile into corneal wavefront data was performed using Zernike polynomials. Total and third- and fourth-order HOAs were considered. The root mean square of the Zernike vector magnitude, expressed in micrometers, was used. Differences among groups were assessed using the Kruskal-Wallis and Duncan multiple range tests. Statistical significance was defined as p < 0.05. RESULTS: In both 4-mm and 6-mm central zones, the total HOAs from the anterior corneal surfaces were significantly lower in DALK than in ALTK and PK groups (p < 0.05). The total HOAs from the posterior corneal surface were comparable amongst postoperative groups (p > 0.05). The aberration components that were significantly greater included coma in the KC and ALTK eyes, trefoil and coma in the DALK eyes, and trefoil in the PK eyes. CONCLUSIONS: The corneal anterior surface optical quality appeared significantly better after DALK than after ALTK and PK.

Long-term effectiveness of autologous cultured limbal stem cell grafts in patients with limbal stem cell deficiency due to chemical burns.

BACKGROUND: Chemical burns cause depletion of limbal stem cells and eventually lead to corneal opacity and visual loss. We investigated the long-term effectiveness of autologous cultured limbal stem cell grafts in patients with limbal stem cell deficiency. DESIGN: Prospective, non-comparative interventional case series. PARTICIPANTS: Sixteen eyes from 16 patients with severe, unilateral limbal stem cell deficiency caused by chemical burns. METHODS: Autologous ex vivo cultured limbal stem cells were grafted onto the recipient eye after superficial keratectomy. MAIN OUTCOME MEASURES: Clinical parameters of limbal stem cell deficiency (stability/transparency of the corneal epithelium, superficial corneal vascularization and pain/photophobia), visual acuity, cytokeratin expression on impression cytology specimens and histology on excised corneal buttons. RESULTS: At 12 months post-surgery, evaluation of the 16 patients showed that 10 (62.6%) experienced complete restoration of a stable and clear epithelium and 3 (18.7%) had partially successful outcomes (re-appearance of conjunctiva in some sectors of the cornea and instable corneal surface). Graft failure (no change in corneal surface conditions) was seen in three (18.7%) patients. Penetrating keratoplasty was performed in seven patients, with visual acuity improving up to 0.8 (best result). For two patients, regeneration of the corneal epithelium was confirmed by molecular marker (p63, cytokeratin 3, 12 and 19, mucin 1) analysis. Follow-up times ranged from 12 to 50 months. CONCLUSIONS: Grafts of autologous limbal stem cells cultured onto fibrin glue discs can successfully regenerate the corneal epithelium in patients with limbal stem cell deficiency, allowing to perform successful cornea transplantation and restore vision.