Two-surgeon, two-center evaluation of a new combined EDOF intraocular lens approach.

PURPOSE: To evaluate visual performance and quality of life after bilateral implantation of 2 extended depth-of-focus intraocular lenses (EDOF IOLs). SETTING: Ophthalmology Clinic, Department of Medicine and Science of Ageing, University "G. d'Annunzio" Chieti-Pescara, Italy, and Ophthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy. DESIGN: Prospective clinical study. METHODS: 60 eyes of 30 patients with senile cataract were enrolled in this study. Patients underwent phacoemulsification and bilateral implantation of the Mini WELL IOL in the dominant eye and the Mini WELL PROXA IOL in the nondominant eye within a month. The main outcome measures over a 3-month follow-up period were uncorrected and corrected visual acuity at different distances (33 cm, 60 cm, and 4 m), defocus curve, contrast sensitivity, and patient satisfaction (evaluated by mean of the National Eye Institute Refractive Error Quality-of-Life instrument-42 questionnaire). RESULTS: Binocular uncorrected visual acuity at 90 days was 0.03 ± 0.11 logMAR for long distance, 0.05 ± 0.10 logMAR for intermediate distance, 0.03 ± 0.08 logMAR at 40 cm, and 0.06 ± 0.08 logMAR at 33 cm. Statistically significant differences between the 2 EDOF IOLs in favor of Mini WELL PROXA IOL were observed for uncorrected near visual acuity at 40 and 33 cm ( P < .001 and P < .001, respectively) and for distance-corrected near visual acuity at 40 cm ( P < .001). Significant differences between the 2 IOLs in the defocus curves were reported. CONCLUSIONS: In this small pilot study, bilateral implantation of Mini WELL IOL and Mini WELL PROXA IOL achieved good quantity and quality of vision.

Choroidal modifications assessed by means of choroidal vascularity index after oral eplerenone treatment in chronic central serous chorioretinopathy.

BACKGROUND: To investigate choroidal vascularity index (CVI) changes after oral eplerenone treatment in chronic central serous chorioretinopathy (cCSC) using the Spectral-domain (SD)-Optical Coherence Tomography (OCT) with enhanced depth imaging (EDI) mode. METHODS: Thirty-six eyes of 18 patients suffering from cCSC with monolateral foveal subretinal fluid (FSRF) successfully treated with oral eplerenone treatment and 18 age-matched healthy subjects were enroled in this retrospective study. EDI-OCT images obtained using Heidelberg Spectralis OCT device in patients with cCSC and FSRF (group 1); fellow eye (group 2) or healthy patients (healthy) were exported and then imported into image analysis ImageJ software for subsequent quantitative analysis. The main outcome measures were luminal area (LA) and CVI. RESULTS: A higher value of CVI was detected in group 1 compared to healthy eyes (p = 0.006). LA and CVI significantly reduced during follow up in group 1 and group 2. LA at 120 days was significantly lower compared to all previous time points both in group 1 and group 2 (p < 0.001). Median and [1st -3rd quartile] CVI values were 0.8 [0.7; 1.1] at baseline, 0.8 [0.7; 0.9] at 30 days; 0.7 [0.6; 0.9] at 60 and 90 days and 0.6 [0.5; 0.8] at 120 days in group 1 (p = 0.007) and 0.7 [0.6; 0.9] at baseline, 0.7 [0.7; 0.8] at 30 days; 0.7 [0.6; 0.7] at 60 and 90 days and 0.6 [0.6; 0.7] at 120 days in group 2 (p = 0.018). CONCLUSIONS: Choroidal vascularity index reduced in cCSC patients after oral eplerenone treatment during follow up both in eyes with SRF and fellow eyes thus demonstrating the effectiveness of mineral corticoid receptor antagonists in recovering choroidal morphology.

Serum microRNA Levels in Diabetes Mellitus.

The aim of our study is to evaluate the serum circulating levels of some miRNA, such as hsa-let-7b-5p, hsa-let-7a-5p, hsa-miR-320b, hsa-miR-23a-3p, hsa-miR-27a-3p, hsa-miR-15a-5p, and hsa-miR-495-3, in diabetic patients without diabetic retinopathy (DR), diabetic patients with DR, and, healthy subjects in order to find reliable and reproducible biomarkers for DR. A total of 45 subjects underwent serum sampling for miRNAs evaluation and a complete ophthalmologic examination, including microperimetry and widefield swept source optical coherence tomography angiography (OCTA). Total circulating RNA was isolated from patients using the miRNeasy Serum/Plasma Kit. Serum miRNA expression levels were significantly different in the three groups. In detail, circulating hsa-miR-15a-5p levels were significantly reduced in both diabetic patients without DR and diabetic patients with DR (p = 0.027). Serum hsa-miR-495-3p was lower in diabetic patients with DR and diabetic patients without DR (p = 0.049). Hsa-miR-23a-3p serum expression levels were significantly lower in diabetic patients with DR and diabetic patients without DR (p = 0.013). Significant associations of miRNAs with anatomical/perfusion parameters and functional parameters were observed in the diabetic groups. We find evidence of damage in progression biomarkers in DR that are evidently early in patients with diabetes without DR. Serum miRNAs levels are considered to have strong potential as a novel biomarker for the early detection of DR in subjects suffering from diabetes and could represent noninvasive target therapies to block the progression of the disease at the early stages.

Oxidative Stress Markers and the Retinopathy of Prematurity.

Retinopathy of prematurity (ROP) is a leading cause of potentially preventable blindness in low birth weight preterm infants. Several perinatal and postnatal factors contribute to the incomplete maturation of retinal vascularization, leading to oxidative stress damage. Literature data suggest that the lack of equilibrium between pro-oxidants and anti-oxidants plays a key role. In the last decade, there has been an increasing interest in identifying the antecedents of ROP and the relevant pathogenic mechanisms involved. In this context, a panel of biomarkers was investigated in order to achieve early detection of oxidative stress occurrence and to prevent retinal damage. Several nutritional elements have been found to play a relevant role in ROP prevention. At this stage, no conclusive data have been shown to support the usefulness of one biomarker over another. Recently, the Food and Drugs Administration, the European Medicine Agency, and the National Institute of Health proposed a series of criteria in order to promote the inclusion of new biomarkers in perinatal clinical guidelines and daily practice. The aim of the present review is to offer an update on a panel of biomarkers, currently investigated as potential predictors of ROP, highlighting their strengths and weaknesses.

In vivo and in vitro results of an automated preloaded delivery system for IOL implantation in cataract surgery.

PURPOSE: To compare the corneal tissue trauma after the use of an automated preloaded injector and a manual injector and assess scanning electron microscope (SEM) and atomic force microscope (AFM) features of both injector cartridges. SETTING: Ophthalmology Clinic and Laboratory of Stem Cells and Regenerative Medicine University "G. d'Annunzio" of Chieti-Pescara, Chieti, Italy; DESIGN: Prospective randomized clinical study METHODS: Forty eyes of 40 patients for phacoemulsification were divided into two groups: implantation of intraocular lens was performed with AutonoMe automated delivery system (AutonoMe group: 20 eyes) and Monarch III injector system (Monarch group: 20 eyes). In vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT) were performed before surgery, at 1 h, 1 day and 1 month post-operatively. In addition, SEM and AFM were performed on cartridges of both injector systems after injection of the IOL. RESULTS: A greater increase in central corneal thickness and corneal thickness at the incision site were observed in Monarch group versus AutonoMe group 1 h and 1 day post-operatively (p < 0.05). Endothelial cell count loss was significantly higher in Monarch group compared with AutonoMe group (p < 0.05) at 1 and 24 h. AS-OCT showed less endothelial misalignment at 30 days (p < 0.05), and IVCM showed less tunnel inflammation at all time points (p < 0.05) in AutonoMe group compared with Monarch group; roughness analysis at AFM of the AutonoMe cartridge was significantly lower compared to Monarch D cartridge (p < 0.05). CONCLUSIONS: The AutonoMe injector provided less corneal tissue trauma compared with Monarch III injector. The AutonoMe cartridge showed lower roughness at AFM compared to the Monarch D cartridge.

The Conjunctiva-Associated Lymphoid Tissue in Chronic Ocular Surface Diseases.

Ocular surface diseases (OSDs) represent a widely investigated field of research given their growing incidence and the negative impact on quality of life. During OSDs, cytokines generated by damaged epithelia trigger and deregulate the lymphoid cells composing the eye-associated lymphoid tissues, inducing an immune-mediated chronic inflammation that amplifies and propagates the disease during time. The conjunctiva-associated lymphoid tissue (CALT), given its particular position that permits immune cells covering the cornea, might play a crucial role in the development of OSDs. Despite the recognized inflammatory role of mucosa-associated lymphoid tissues in other stations taking contact with the external environment (gut or bronchus), CALT did not gain the deserved consideration. In the last years, the diffusion of the in vivo confocal microscopy (IVCM) stimulated the interest to CALT, especially in dry eye, ocular allergy, and glaucoma. Though the initial stimuli were different, IVCM documented similar changes, represented by increased lymphoid cells within the diffuse layer, follicles and interfollicular spaces. These findings, which need to be validated by immunohistology, support the CALT stimulation during OSDs. However, while an involvement of the CALT in OSDs is hypothesizable, the exact role of this structure in their pathogenesis remains unclear and warrants further investigations.

All laser cataract surgery compared to femtosecond laser phacoemulsification surgery: corneal trauma.

The aim of this study was to evaluate corneal tissue trauma after femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification (femtophaco surgery) compared to FLACS and nanolaser emulsification (all laser surgery). This is a prospective nonrandomized clinical study conducted at the Ophthalmology Clinic, University "G. d'Annunzio" of Chieti-Pescara, Italy, involving forty-two eyes of 42 patients candidates to cataract surgery. Patients were enrolled in two groups: femtophaco surgery (group 1 with 21 eyes) and all laser surgery (group 2 with 21 eyes). Main outcome measures included uncorrected visual acuity and distance corrected visual acuity, corneal endothelial cell count, and corneal thickness at the tunnel site and at the center of the cornea. Best correct visual acuity was not significantly different between the two groups. Postoperatively, a significant decrement of endothelial cell count at the center of the cornea was observed in group 1 compared with preoperative values at 90 days (p < 0.001) while t remained stable in group 2. The central corneal thickness showed a statistically significant increase for both groups that reached a maximum thickness at 7 days and then returned to presurgery levels after 90 days for group 1 and after 60 days for group 2. The tunnel corneal thickness showed a statistically significant increase for both groups that reached a maximum thickness at 7 days, which did not return to presurgery level for group 1 but did return to presurgery levels after 60 days for group 2. All laser surgery induced lower central endothelial cell loss and lower increase of corneal thickness compared to femtophaco surgery.

Postoperative IOL Axial Movements and Refractive Changes After Femtosecond Laser-assisted Cataract Surgery Versus Conventional Phacoemulsification.

PURPOSE: To evaluate intraocular lens (IOL) axial movements and refractive changes during a 6-month follow-up period after femtosecond laser-assisted cataract surgery and conventional cataract surgery, investigate the influence of capsulorhexis features on postoperative IOL axial changes, and assess the prediction error for both techniques. METHODS: Eighty eyes of 80 candidates for cataract extraction were randomized into two groups: femtosecond laser (40 eyes) and manual (40 eyes). RESULTS: The overall anterior chamber depth variation was significantly lower in the femtosecond laser group compared to the manual group during follow-up (P<.001). At 30 and 180 days postoperatively, the mean spherical equivalent showed a hyperopic shift (0.09±0.28 diopters [D]) in the femtosecond laser group and a myopic shift in the manual group (-0.25±0.18 D). Median absolute error was not significantly different between the two groups with standard formulas ranging between 0.29 and 0.64 (Hoffer Q) in the femtosecond laser group and between 0.24 (SRK-T) and 0.55 D (Hoffer Q) in the manual group. There was a significant lower deviation from intended versus achieved capsulotomy/capsulorhexis area in the femtosecond laser group (P<.001) compared to the manual group. The femtosecond laser group showed better IOL centration compared to the manual group at all time periods (P<.001). CONCLUSIONS: Femtosecond laser-assisted cataract surgery was related to a lower overall variability of anterior chamber depth compared to conventional cataract surgery with more stable postoperative refraction. The two techniques did not show significant differences of prediction error.

Multifocal IOL implant with or without capsular tension ring: study of wavefront error and visual performance.

PURPOSE: To evaluate visual performance and wavefront error after multifocal intraocular lens (MIOL) implant with or without capsular tension ring (CTR). METHODS: Sixty eyes of 60 candidates for phacoemulsification and MIOL implantation were included in the study and were randomly divided into 2 groups. Thirty eyes (group 1) were implanted with the AcrySof ReSTOR® SN60D3 MIOL and Corneal® ACPI 11 CTR and 30 eyes (group 2) received the same MIOL with no CTR. RESULTS: Twenty days and at 360 days after surgery, the uncorrected and corrected distance visual acuity at high and low contrast were not significantly different between the 2 groups. The root mean square (RMS) of ocular and internal wavefront error was significantly different in the 2 groups early after surgery and did not modify significantly over the 1-year follow-up period. The RMS of total and internal high-order aberrations and ocular and internal trefoil and coma aberrations were significantly lower in group 1 compared to group 2 (p<0.05). Ocular, corneal, internal modulation transfer function at high and low spatial frequencies and ocular, corneal, internal Strehl ratio were not significantly different between the groups. The IOL decentration and tilt were higher in group 1 compared to group 2. CONCLUSION: ReSTOR MIOL was effective in improving visual performance and provided a good quality of vision due to a significant reduction of high-order spherical aberration. The implant of CTR additionally reduced the ocular wavefront error related to a reduction of third-order aberration related to better IOL position.

Comparative study of Acrysof ReSTOR multifocal intraocular lenses +4.00 D and +3.00 D: visual performance and wavefront error.

BACKGROUND: The aim was to evaluate visual performance and wavefront error after implantation of three models of Acrysof ReSTOR multifocal intraocular lenses (MIOLs). METHODS: This prospective comparative six-month study comprised 60 eyes having phacoemulsification and implantation of three diffractive AcrySof ReSTOR MIOLs: SN60D3 +4.00 D spherical MIOL (group 1), SN6AD3 +4.00 D aspheric MIOL (group 2) and SN6AD1 +3.00 D aspheric MIOL (group 3). RESULTS: The distance visual acuity was at least 0.1 logMAR in 88.8 per cent of group 1, 88.8 per cent of group 2 and 87.5 per cent of group 3. The distance-corrected near vision was 0.02 ± 0.04 logMAR in group 1, 0.02 ± 0.05 logMAR in group 2 and 0.01 ± 0.03 logMAR in group 3 (p = 0.822). The distance-corrected intermediate vision was 0.26 ± 0.07, 0.22 ± 0.09 and 0.04 ± 0.05, respectively (p < 0.001). The root-mean-square (RMS) of ocular spherical aberration was significantly lower in groups 2 and 3 compared to group 1 (p = 0.048). CONCLUSION: All diffractive MIOLs provided good vision for far and near. ReSTOR MIOL +3.00 also restored intermediate vision. Aspheric MIOLs +4.00 and +3.00 induced significantly lower spherical aberration compared to spherical MIOL +4.00.

Visual performance and biocompatibility of 2 multifocal diffractive IOLs: six-month comparative study.

PURPOSE: To evaluate the distance and near functional capacity, wavefront error and biocompatibility in patients with 2 diffractive multifocal intraocular lenses (MIOLs). SETTING: Ophthalmology Department of Chieti-Pescara University (Italy). METHODS: This prospective study comprised 28 eyes of 28 senile cataract patients having phacoemulsification and implantation of the Tecnis ZM900 MIOL (Group 1) and the AcrySof ReSTOR MIOL (Group 2). The main outcome measures, over a 6-month follow-up period, were spherical equivalent, distance visual acuity at high and low contrast, near visual acuity, and defocus curve. Wavefront error was evaluated in both groups. Capsule opacification was also assessed. RESULTS: The high and low contrast uncorrected and best corrected visual acuity for distance did not show statistically significant differences between the 2 groups. The distance corrected near visual acuity was 1.86 +/- 1.66 in Group 1 and 1.93 +/- 1.12 in Group 2. The depth of focus was 4.5 diopters in both groups. The root mean square of total aberration and of spherical and coma aberrations were significantly lower in Group 1 than in Group 2. A higher percentage of patients with Tecnis MIOLs showed a more severe grade of anterior fibrosis. Posterior opacification was minimal and not significantly different between the 2 groups. CONCLUSION: Diffractive MIOLs were effective in improving functional capacity for distance and near and provided a good quality of vision due to a significant reduction in spherical aberration, particularly in the Tecnis MIOLs. The higher capsular biocompatibility of the ReSTOR MIOL compared with the Tecnis MIOL could ensure long-term stability.

Longterm results of 1 CU accommodative intraocular lens implantation: 2-year follow-up study.

PURPOSE: To evaluate the longterm efficacy of 1 CU accommodative intraocular lenses (IOLs) to restore near visual performance. METHODS: This prospective study comprised 14 eyes previously included in a 6-month, case-control clinical trial, undergoing phacoemulsification and implantation of a 1 CU accommodative IOL. The main outcome measures were subjective refraction, uncorrected distance visual acuity (UCDVA), best corrected distance VA (BCDVA), distance-corrected near VA (DCNVA), best corrected near VA (BCNVA), and subjective amplitude of accommodation (AA). In addition, anterior and posterior capsule opacification were assessed. Patients were examined over a 2-year follow-up period. RESULTS: Distance and near visual performance worsened after 6 months. Uncorrected DVA and BCDVA were 0.8 +/- 2.1 and 1.0 +/- 0.8 at 6 months and 0.4 +/- 0.1 and 0.6 +/- 0.1 at 1 year, respectively (p = 0.001). Distance-corrected NVA and BCNVA were 3.7 +/- 2.1 Jaeger (J) and 1.0 +/- 0.7 J at 6 months and 8.1 +/- 0.7 J and 1.5 +/- 0.5 J at 1 year, respectively (p = 0.001). Anterior and posterior capsule opacification were present, respectively, in 28% and 21% of patients at 6 months and in 100% of patients at 1 and 2 years (p < 0.001). After Nd:YAG laser capsulotomy (performed in 100% of patients), UCDVA and BCDVA increased to 0.7 +/- 0.2 (p = 0.007) and 1.0 +/- 0.1 (p = 0.001), respectively, at 2 years. Distance-corrected NVA improved to 7.3 +/- 0.5 J (p = 0.006). Mean AA was 1.9 +/- 0.8 D at 6 months, 0.3 +/- 0.2 D (p = 0.004) at 1 year and 0.3 +/- 0.2 D at 2 years. CONCLUSIONS: Patients implanted with 1 CU IOLs lost their accommodation capacities with time because of the high incidence and degree of anterior and posterior capsule opacification. The accommodative lens material and design may have played a role in capsule fibrosis.

Long-term complications of bilateral posterior chamber phakic intraocular lens implantation.

A 34-year-old woman had posterior chamber phakic intraocular lens (PCP IOL) implantation to correct high myopia in both eyes. Five years postoperatively, the patient presented with a decrease in visual acuity from central anterior subcapsular cataract formation in both eyes and IOL dislocation in the left eye. In vivo confocal microscopy of the cornea showed markedly decreased endothelial cell density in both eyes and the presence of bright endothelial microdeposits possibly related to pigmentary dispersion. Gonioscopy showed angle pigmentary deposits with no intraocular pressure increase. The patient was successfully treated by removing the PCP IOLs and performing phacoemulsification with in-the-bag IOL implantation in both eyes. This led to a recovery of visual acuity. This case report presents the rare occurrence and surgical management of cataract formation, IOL dislocation, and severe endothelial cell loss as a late complication of PCP IOL implantation.

Clinical study of the 1CU accommodating intraocular lens.

PURPOSE: To compare the near functional capacities of patients with an accommodating intraocular lens (IOL) with those of patients with a conventional monofocal IOL. SETTING: Department of Ophthalmology, University of Chieti, Chieti, Italy. METHODS: This prospective double-blind case-control study comprised 42 eyes that had phacoemulsification and implantation of 1 of 2 types of IOLs: HumanOptics accommodating 1CU(R) (study group) and Eurocrystal IFP 3G 6.00 (control group). The main outcome measures were subjective refraction, uncorrected distance acuity, best corrected distance acuity, distance corrected near acuity at 40 cm, best corrected near acuity at 40 cm, and subjective amplitude of accommodation. Patients were examined 7, 30, 90, and 180 days after surgery. RESULTS: Postoperatively, both groups had excellent uncorrected distance acuity, best corrected distance acuity, and best corrected near acuity. In the study group, the mean distance corrected near acuity (Jaeger) was 5.43 +/- 0.98 (SD) (range 4 to 7) at 7 days, 2.33 +/- 0.48 (range 2 to 3) at 1 and 3 months, and 3.66 +/- 2.12 (range 2 to 7) at 6 months. In the control group, the mean distance corrected near acuity was 7.43 +/- 0.50 (range 7 to 8) during the entire follow-up. The differences between the groups was statistically significant (P<.001). The mean amplitude of accommodation was 0.00 diopter (D) in the control group and 1.14 +/- 0.44 D (range 0.75 to 2.00 D) in the study group at 7 days, 2.36 +/- 0.28 D (range 2.00 to 2.75 D) at 30 and 90 days, and 1.90 +/- 0.77 D (range 0.75 to 2.75 D) at 6 months. CONCLUSIONS: The 1CU accommodating IOL provided better useful spectacle-free near visual acuity than the conventional monofocal IOL. However, the accommodating mechanism can play a role in capsule fibrosis.

Reliability of nerve fiber layer thickness measurements using optical coherence tomography in normal and glaucomatous eyes.

OBJECTIVE: To evaluate the reliability of nerve fiber layer (NFL) thickness measurements by optical coherence tomography (OCT) in normal and glaucomatous eyes. DESIGN: Prospective, comparative, observational case series and instrument validation study. PARTICIPANTS: Twenty-four glaucomatous patients were compared with 24 gender- and age-matched normal subjects. METHODS: Each individual underwent OCT measurements of NFL thickness. Five repetitions of a series of scans on five separate occasions within a 0.5-month period were performed. Each eye was scanned at three different nerve head programs (1.5 radius [R], R = 1.73 mm, 2.0 R). For each option (1.5 R, R = 1.73 mm, and 2.0R) and region (superior, inferior, temporal, nasal, and overall mean), variance components and intraclass correlation coefficients were determined using repeated measures regression. In these models, NFL thickness, as measured by OCT, was assumed to have three variance components: intersubject, intervisit (within-subject between-dates), and intravisit (within-subject within-date). The intraclass correlation coefficient (intersubject variance/total variance) was used as a measure of reliability. MAIN OUTCOME MEASURES: Measurements of NFL thickness using OCT were performed. RESULTS: Reliability values, as measured by intraclass correlation coefficients, resulted as follows: 1.5 R, 0.54/0.52 (normal/glaucoma); R = 1.73 mm, 0.50/0.50; 2.0 R, 0.49/0.50. CONCLUSIONS: Our results indicate that the recent commercially available OCT provides reliable NFL thickness measurements in both healthy and glaucomatous eyes with each circle radius tested. The greatest amount of variability can be attributed to intersubject differences.