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.

Intraoperative Iridectomy in Femto-Laser Assisted Smaller-Incision New Generation Implantable Miniature Telescope.

BACKGROUND: In this study, we aimed to report the short-term (6 months) effects on visual functionality and safety of femto-laser assisted smaller-incision new-generation implantable miniature telescope (SING-IMT™) implanting, particularly related to postsurgical intraocular pressure increase, in patients suffering from end-stage age-related macular degeneration (AMD) and cataract. This device, designed for monocular use, aims to minimise the impact of the central scotoma by projecting the images onto a larger area of the photoreceptors surrounding the macula. METHODS: In this prospective multicentric observational case series study, 6 eyes of 6 patients who underwent SING-IMT™ implantations were enrolled. At baseline and 6 months follow-up, best corrected distance visual acuity (BCDV) and best corrected near visual acuity (BCNVA), intraocular pressure (IOP), anterior chamber depth, endothelial cells count were assessed. In addition, IOP was also measured at 7, 15, 30, 45 days, and at 3 months follow-up. Finally, the incidence of complications was evaluated. RESULTS: At final follow-up, in the study eyes, mean BCDVA improved by +10.0 letters (6.25; 13.8) letters and mean BCNVA improved by -0.30 logMAR (-0.55; -0.20). At postoperative month 6, we reported a mean IOP decrease of 4.50 mmHg (-5.75; -0.25). Interestingly, 83.3% of patients had an increased IOP value in at least one of the first two postoperative follow-ups (7 days and 15 days). In patients in whom intraoperative mechanical iridotomy was not performed, it was necessary to perform a postoperative YAG laser iridotomy to improve IOP management. Compared to the baseline, ECD loss at 6 months follow-up was 12.6%. CONCLUSIONS: The SING IMT™ device was found to be effective in the distance and near vision improvement, without serious postoperative complications. We recommend intraoperative mechanical iridectomy in order to easily manage post-operative IOP and to avoid sudden IOP rise with its possible consequences. These good results can be a hope to partially improve the quality of life of patients suffering from severe end stage macular atrophy.

Visual Performance and Quality of Life after Femtosecond Laser-Assisted Cataract Surgery with Trifocal IOLs Implantation.

PURPOSE: To assess visual performance and quality of life after implantation of diffractive trifocal IOLs with enhanced depth of focus (Acriva Reviol Tri-ED) compared to monofocal IOLs. SETTING: Ophthalmology Clinic, Department of Medicine and Science of Ageing, University "G. d'Annunzio" Chieti-Pescara, Italy. DESIGN: Prospective clinical study. METHODS: This study comprised 36 eyes of 18 patients with senile cataract candidates for phacoemulsification and implantation of the Acriva Reviol Tri-ED (Group 1-18 eyes) and the AcrySof IQ Monofocal IOL SN60WF (Group 2-18 eyes). The main outcome measures, over a 6-month follow-up period, were uncorrected and corrected visual acuity at different distances (40, 60 cm and 4 m), defocus curve, contrast sensitivity and wavefront error. Patient satisfaction was evaluated by means of the NEI-RQL-42 questionnaire. RESULTS: At 180 days postoperatively, the difference of the UCDVA and CDVA between the groups was not statistically significant (p = 0.888 and p = 0.843, respectively). The difference between the groups was statistically significant for UCIVA (p = 0.019) and UCNVA (p = 0.036). The mean values of contrast sensitivity under photopic and mesopic conditions were not significantly different between the groups. The RMS of spherical aberration was significantly lower in Group 1 compared to Group 2. The NEI-RQL-42 questionnaire showed statistically significant differences between the groups for the dependence on correction (p < 0.001). CONCLUSIONS: The diffractive trifocal IOL with enhanced depth of focus Acriva Reviol Tri-ED was effective in improving functional capacity for intermediate and near vision compared to monofocal IOLs and provided a good quality of vision due to a significant reduction in spherical aberration.

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.

Optical coherence tomography and 3-dimensional confocal structured imaging system-guided femtosecond laser capsulotomy versus manual continuous curvilinear capsulorhexis.

PURPOSE: To compare the features of capsulotomy obtained during femtosecond laser-assisted cataract surgery with those of continuous curvilinear capsulorhexis (CCC) obtained using a standard manual technique. SETTING: Ophthalmology Clinic, Department of Medicine and Science of Ageing, University G. D'Annunzio Chieti-Pescara, Chieti, Italy. DESIGN: Prospective randomized clinical study. METHODS: Candidates for cataract extraction were randomized into 1 of 3 groups as follows: Lensx femtosecond laser-assisted cataract surgery capsulotomy (laser group 1), Lensar femtosecond laser-assisted cataract surgery capsulotomy (laser group 2), and manual CCC (manual group). RESULTS: Each group comprised 30 eyes (30 patients). The capsulotomies in laser group 1 and laser group 2 showed significantly better circularity than the manual CCCs at 7 days (P<.001). There was a significant correlation between the intended versus achieved capsulotomy size in the 2 laser groups. Both laser groups had better intraocular lens (IOL) centration than the manual group at all timepoints (P<.001). Between-group differences in uncorrected and corrected distance visual acuities were not statistically significant. The residual spherical equivalent and mean absolute error were statistically significantly smaller in the 2 laser groups than in the manual group (P=.038) and increased significantly over time in all the groups (P<.001). CONCLUSIONS: Femtosecond laser capsulotomies showed better circularity with more predictable size than manual CCCs. In addition, IOL centration was better immediately after surgery and over time with better refractive results in the 2 laser groups.

Femtosecond laser versus manual clear corneal incision in cataract surgery.

PURPOSE: To compare functional and morphological outcomes of femtosecond laser clear corneal incision (CCI) versus manual CCI during cataract surgery. METHODS: Sixty eyes of 60 patients who underwent CCI during cataract surgery were randomized into two groups: femtosecond laser CCI (30 eyes) and manual CCI (30 eyes). RESULTS: There were no significant between-group differences in uncorrected distance visual acuity, corrected distance visual acuity, surgically induced astigmatism, and corneal aberrations. Keratometric astigmatism was significantly lower in the femtosecond laser CCI group compared to the manual CCI group at 30 and 180 days (P < .05). Central endothelial cell count was significantly higher in the femtosecond laser CCI group compared to the manual CCI group at 7 and 30 days postoperatively (P < .05). A lower increase of corneal thickness at the incision site was observed at 30 and 180 days postoperatively in the femtosecond laser CCI group compared to the manual CCI group (P < .05). In addition, femtosecond laser CCI showed a better morphology (lower percentage of endothelial and epithelial gaping and endothelial misalignment) compared to manual CCI at different time points. Total phacoemulsification time was significantly lower in the femtosecond laser CCI group (P < .05). CONCLUSIONS: The femtosecond laser procedure was safe, efficient, and less damaging, as evidenced by lower central endothelial cell loss, lower increase of corneal thickness at the incision site, and better tunnel morphology compared to the manual technique.

Scanning electron microscopy evaluation of capsulorhexis in femtosecond laser-assisted cataract surgery.

PURPOSE: To use scanning electron microscopy (SEM) to evaluate capsulorhexis-cut quality obtained during femtosecond laser-assisted cataract surgery at different energy settings and evaluate whether there are differences between this technique and a standard manual technique. SETTING: Ophthalmology Clinic, Department of Medicine and Science of Ageing, University G. D'Annunzio Chieti-Pescara, Chieti, Italy. DESIGN: Prospective nonrandomized single blinded study. METHODS: Sixty capsulorhexes obtained using the conventional manual technique and the femtosecond laser with different laser energy settings were divided into 5 groups as follows: Group 1 (12 capsulorhexes) obtained with the manual technique and Groups 2 to 5 (each with 12 capsulorhexes) obtained with the femtosecond laser at 7.0 µJ, 13.5 µJ, 14.0 µJ, and 15.0 µJ, respectively. All samples were evaluated using SEM to compare the thickness along the capsulorhexis edge and the overall irregularity of the cut surface. RESULTS: Capsulorhexes obtained with the femtosecond laser at all energy settings were perfectly circular with negligible deformation. Group 1 and Group 2 had a significantly higher thickness and lower thickness, respectively, of the capsulorhexis edge than the other 3 groups (P<.001). There was also a statistically significant correlation between the degree of irregularity and increasing energy (P<.001). CONCLUSIONS: The use of the femtosecond laser in cataract surgery resulted in better capsulorhexis geometry and circularity than the manual capsulorhexis. The cut surface was smoother in the manual group. In the femtosecond laser groups, the degree of irregularity was higher at increasing energy settings. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Astigmatism correction with toric IOL: analysis of visual performance, position, and wavefront error.

PURPOSE: To evaluate astigmatism correction, visual performance, intraocular lens (IOL) position, and wavefront error after implantation of toric IOLs in patients with cataract. METHODS: This prospective study comprised 30 eyes of 30 patients with cataract who were candidates for phacoemulsification and implantation of the AcrySof toric IOL (Alcon Laboratories, Inc., Fort Worth, TX). Mean preoperative corneal keratometric and subjective refractive cylinder were 2.10 ± 0.47 and 2.17 ± 0.41 diopters (D), respectively. RESULTS: The refractive cylinder decreased significantly from 2.17 ± 0.41 to 0.73 ± 0.45 D (P = .001) at 180 days postoperatively. The difference between preoperative corneal astigmatism and postoperative refractive astigmatism was statistically significant (P < .05). At 180 days postoperatively, the uncorrected distance visual acuity was 0.20 logMAR (Snellen 20/32) in 100% of patients and 0.0 logMAR (Snellen 20/20) in 64% of patients. The root mean square of internal coma and trefoil aberrations showed a trend toward reduction; internal spherical aberration significantly decreased, whereas corneal trefoil aberration significantly increased (P < .05). A low amount of IOL decentration and tilt were detected at 30 and 180 days postoperatively, respectively. CONCLUSIONS: Toric IOL implantation is an effective procedure for correction of preexisting corneal astigmatism, improving visual performance, and inducing a low amount of higher-order aberrations. Moreover, the toric IOLs is well positioned early after surgery and stable over time.

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.

AcrySof cachet phakic intraocular lens in myopic patients: visual performance, wavefront error, and lens position.

PURPOSE: To evaluate visual and aberrometric outcomes and position of the AcrySof Cachet (Alcon Laboratories Inc) angle-supported phakic intraocular lens (PIOL) for correction of myopia in adults. METHODS: This prospective study included 36 consecutive eyes with moderate to high myopia in which an AcrySof Cachet PIOL was implanted to minimize refractive error. Follow-up was up to 1 year. RESULTS: Mean manifest spherical equivalent refraction reduced significantly from -14.90 ± 0.90 diopters (D) to -0.29 ± 0.30 D at 1 month and remained stable at 1 year (P<.001). Mean uncorrected distance visual acuity was >0.1 logMAR (20/20 Snellen) in 56% of patients and >0.3 logMAR (20/25 Snellen) in 100% of patients. Corrected distance visual acuity was >0.1 logMAR (20/20 Snellen) in 78% of patients and >0.3 logMAR (20/25 Snellen) in 100% of patients. Mean endothelium-PIOL distance and mean PIOL-crystalline distance were within recommended values at all postoperative evaluations. Statistically significant variations for these variables were not observed. Anterior chamber depth, safety center distance, and vault center distance showed significant reduction after accommodation (P<.01). Anterior chamber depth and safety center distance significantly increased after pupil dilation (P<.01). Mean percentage of endothelial cell loss was 4.04% at 1 year. The root-mean-square of total higher order aberrations and spherical, coma, and trefoil aberrations did not change significantly from pre- to postoperatively. CONCLUSIONS: The AcrySof Cachet PIOL was effective in the correction of moderate to high myopia and provided excellent visual performance with no modification of physiologic ocular wavefront error. Adequate distance from the cornea and crystalline lens was maintained with no significant change during follow-up and under different environmental conditions.

Microcoaxial torsional cataract surgery 1.8 mm versus 2.2 mm: functional and morphological assessment.

BACKGROUND AND OBJECTIVE: To compare functional and morphological outcomes of 1.8-mm versus 2.2-mm microincision coaxial cataract surgery (MCCS). PATIENTS AND METHODS: Thirty eyes of 30 patients that underwent MCCS were randomized to two groups: 1.8-mm MCCS (group 1: 15 eyes) and 2.2-mm MCCS (group 2: 15 eyes). RESULTS: There were no significant between-group differences in uncorrected visual acuity, best-corrected visual acuity, keratometric astigmatism, and endothelial cell count. One day postoperatively, a greater increase of corneal thickness at the incision site was observed in group 1 compared to group 2 using anterior segment optical coherence tomography with no significant differences in tunnel morphometric features and confocal microscopy showed more tunnel edema in group 1 versus group 2 that resolved in both groups. CONCLUSION: Both 1.8- and 2.2-mm torsional MCCS were safe and efficient with easy surgical maneuvers and excellent functional and morphological results; 1.8-mm MCCS induced slightly greater tunnel edema shortly after surgery that resolved in the medium term.

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.