A Prospective Randomized Study Comparing 27-Gauge Vitrectomy to 23-Gauge Vitrectomy for Epiretinal Membranes and Full-Thickness Macular Holes.

Purpose: To compare the surgical and clinical outcomes of 27-gauge vitrectomy and 23-gauge vitrectomy. Methods: We conducted a single-center, prospective, randomized study. Fifty-three patients affected by vitreoretinal interface disorders (epiretinal membranes and macular holes) were randomly scheduled to undergo 27-gauge (28 patients) or 23-gauge (25 patients) pars plana vitrectomy. The presence of any potential factor of increased baseline inflammation or eye anatomy influencing the surgery was criteria for exclusion. The time of surgery, postoperative intraocular pressure (IOP), state of sclerotomy wounds, rate of complications, postoperative pain, and indicators of inflammation were studied. We also introduced a new parameter to compare intraocular inflammation after surgery, given by the change in the number of intraretinal hyperreflective foci (HRF). Results: The 27-gauge vitrectomy was 1.28 min longer than 23-gauge vitrectomy (P < 0.05). The day after surgery, the mean IOP value was significantly higher in the 27-gauge group (16.12 mmHg versus 13.04 mmHg in the 23-gauge group,P < 0.05), but this difference disappeared in successive follow-ups and the sclerotomy wounds closed after 2 weeks in the both groups. The rate of postoperative hypotony did not significantly differ in the two groups (10.71% in the 27-gauge group and 8% in the 23-gauge group the day after the surgery,P = 0.94). Less postoperative eye redness was seen in 27-gauge eyes (value 1 on the scale) compared to 23-gauge (value 2 on the scale) (P < 0.05), but there was no significant difference in intraocular inflammation (cells, Tyndall, and number of HRF,P > 0.05 for all). Conclusions: The 27-gauge vitrectomy may have better outcomes in terms of IOP maintenance and cause less redness after the surgery but with a slightly prolonged surgery time and no other differences under other parameters (inflammation, rate of complications, postoperative pain, visual gain, and closure of the sclerotomy wounds).

Results of ultrathin Descemet stripping automated endothelial keratoplasty with donor corneas preserved in synthetic organ culture media.

PURPOSE: To evaluate outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) with donor corneas preserved at 31°C in Cornea Syn®, a medium formulated with recombinant human serum albumin (rHSA) to replace foetal calf serum, and deswelled-transported in the xeno-free medium Cornea Trans®. METHODS: Prospective, multicentre, open-label study. We evaluated the endothelial cell loss (ECL) as the percentage variation of the endothelial cell density (ECD, cells/mm2) between 6 and 12 months after surgery, corneal transparency and thickness at 12 months, and adverse events within 12 months. Endothelial lenticules of mean 89 µm, ECD ≥ 2300 cells/mm2, minimum signs of cell mortality or morphology alterations, were dissected by microkeratome in the eye bank, and grafted in patients ≥ 18 years without corneal neovascularisation, conjunctivalization, or blinking impairment. RESULTS: Thirty-five patients underwent UT-DSAEK, 3 showed primary failure, 1 late failure, and 2 skipped the 6-month visit. We analysed data from 29 patients, 27 with Fuchs endothelial corneal dystrophy (FECD) and 2 with pseudophakic bullous keratopathy (PBK). The median ECL between 6 and 12 months was 2.6% (p = .054, CI 0 to 12.5) and the absolute mean (SD) was 158.4 (364.1) cells/mm2. After 12 months, 96.5% of corneas were clear, with mean pachymetry of 585.9 (50.4) µm. CONCLUSIONS: The ECL rate after UT-DSAEK match overall that observed in DSAEK or UT-DSAEK models of endothelial survival and the overall safety compared that reported for similar follow-up. Corneas maintained in Cornea Syn® and Cornea Trans® did not affect the ECD and functional outcomes of UT-DSAEK up to 12 months.

Femtosecond laser-assisted deep anterior lamellar keratoplasty: A safer option in keratoconus surgery.

PURPOSE: To evaluate postoperative safety of femtosecond laser deep anterior lamellar keratoplasty performed with an innovative anvil profile in keratoconus patients. METHODS: This is a single-center, retrospective cohort study. We reviewed medical records of 89 keratoconus patients that underwent femtosecond laser deep anterior lamellar keratoplasty surgery (46 eyes) and manual deep anterior lamellar keratoplasty (47 eyes). Inclusion criteria required: age > 18 years old, best-corrected visual acuity < 0.3 LogMAR, continuous suture of the graft, postoperative immunomodulant regimen with dexamethasone 0.1% for 6 months and at least 12 months follow-up. Previous eye surgery, hydrops, and other ocular disease were excluded. The main outcome measures were postoperative events: rejections, persistent epithelial defects, and graft failures. RESULTS: During the follow-up (20 ± 6 months) graft rejection was diagnosed in 0 of femtosecond laser deep anterior lamellar keratoplasty versus 6 (17%) of manual deep anterior lamellar keratoplasty [p 0.027], persistent epithelial defect in 0 of femtosecond laser deep anterior lamellar keratoplasty versus in 4 (11%) of manual deep anterior lamellar keratoplasty [p 0.048] and graft failure occurred in 4 (11%) of manual deep anterior lamellar keratoplasty. The best-corrected visual acuity, after removal of sutures, was better in the femtosecond laser deep anterior lamellar keratoplasty group 0.09 ± 0.08 LogMAR versus 0.16 ± 0.13 LogMAR in manual deep anterior lamellar keratoplasty [p 0.035] group although refractive spherical equivalent and cylinder, topographic average keratometry and cylinder were similar. CONCLUSIONS: Anvil-shaped femtosecond laser deep anterior lamellar keratoplasty in keratoconus surgery increases safety and readiness of recovery, decreasing the incidence of corneal rejection, epithelial defects, graft failures, and producing better best-corrected visual acuity after removal of sutures.

Gender medicine in corneal transplantation: influence of sex mismatch on rejection episodes and graft survival in a prospective cohort of patients.

To evaluate the effect of donor-to-recipient sex mismatched (male donor corneas to female recipients) on the incidence of rejection episodes and failures up to 1 year after corneal transplantation. Prospective observational cohort study, with donor corneas randomly assigned and surgeons blind to the sex of donor. A unique eye bank retrieved and selected the donor corneas transplanted in 4 ophthalmic units in patients with clinical indication for primary or repeated keratoplasty for optical reasons, perforating or lamellar, either anterior or posterior. Rejection episode defined as any reversible or irreversible endothelial, epithelial or stromal sign, with or without development of corneal edema, and graft failure as a permanently cloudy graft or a regraft for any reason detected or acknowledged during a postoperative ophthalmic visit at any time up to 1 year after surgery were recorded.156 (28.6%) patients resulted donor-to-recipient gender mismatched for H-Y antigen (male donor to female recipient). During the 12 months follow-up, 83 (14.7%, 95% CI 12.0-17.9) grafts showed at least 1 rejection episode and 17 (3.2%, 95% CI 2.0-5.0) failed after immune rejection, among 54 (9.6%, 95% CI 7.4-12.3) grafts failed for all causes. No significant differences between matched and mismatched patients were found for cumulative incidence of both rejection episodes (15.2% and 13.5%) and graft failures following rejection (3.2% and 2.6%), respectively. Multivariable analyses showed that H-Y matching either is not a predictive factor for rejection or graft failure nor seems to influence incidence of failures on respect to patient's risk category. The lack of influence of donor-to-recipient mismatched on the rate of rejections and graft failures resulting from this study do not support the adoption of donor-recipient matching in the allocation of corneas for transplantation.

Functional and morphological outcomes after surgery in lamellar macular holes versus epiretinal membrane foveoschisis.

PURPOSE: To compare the clinical findings and outcomes of vitrectomy for lamellar macular holes (LMH) versus epiretinal membrane foveoschisis (ERMF). MATERIALS AND METHODS: This retrospective study enrolled 36 eyes of 35 patients with a minimum follow-up of 6 months. Spectral domain optical coherence tomography (SD-OCT) parameters and best-corrected visual acuity (BCVA) were analyzed preoperatively and postoperatively. RESULTS: The 19 (52.8%) ERMF and 17 (47.2%) LMH were included. Preoperatively, eyes with LMH were characterized by a lower central foveal thickness (CFT) (102.18 ± 31.44 µm vs 159.37 ± 25.25 µm, p < 0.001) and a greater incidence of outer retinal disruption (p < 0.001). Primary anatomical success was achieved in 34/36 eyes (94.4%). Preoperative BCVA was better in ERMF (0.16 - IQR 0.09 - logarithm of the minimal angle of resolution (LogMAR) - 20/28 Snellen) than LMH (0.40 - IQR 0.30 - LogMAR, 20/50 Snellen) (p = 0.008). At 6 months after surgery, BCVA significantly improved in the ERMF group (p < 0.001), but showed insignificant change in LMH (p = 0.125). Two cases, both in the LMH group, developed full thickness macular hole after surgery. CONCLUSION: Eyes with LMH showed visual stabilization after surgery, whereas the eyes in the ERMF group were susceptible to functional improvement. These differences in BCVA outcomes may be the consequence of a higher damage in the outer retina in the LMH group; an accurate SD-OCT examination is a fundamental step when deciding to proceed or not to the surgery.

An anomalous foveal OCT-sign after posterior capsule rupture in cataract surgery: Complicated cataract surgery maculopathy.

PURPOSE: To report a series of novel optical coherence tomography (SD-OCT) foveal abnormalities, that we called "T-sign," that were noticed after a complicated cataract surgery with posterior capsule rupture and vitreous loss. METHODS: Retrospective case series of persistent foveal changes that incurred after anteroposterior vitreo-foveal traction secondary to phacoemulsification in presence of posterior capsule rupture. RESULTS: The study included three eyes of three patients that incurred in complicated cataract surgery and intraoperative vitreo-foveal traction. During 8-month follow-up period peculiar abnormalities in fundus examination and in OCT scans were reported in all cases. CONCLUSION: Phacoemulsification in presence of posterior capsule rupture could induce a vitreo-foveal strain that could be transmitted to the cone outer segment tips (COST line) and inner-outer segment (IS/OS) junction. This focal stress is liable for "T-sign," a persistent SD-OCT abnormality that induce a visual impairment and a slight metamorphopsia in the fixation point. SUMMARY STATEMENT: All over the world, more than 9.5 million cataract surgeries are completed each year.1 During surgery, many intraoperative complications could occur, and capsule rupture with vitreous loss is a frequent event. Phacoemulsification in presence of a wide posterior capsule rupture and vitreo-macular adhesion could induce a typical modification of the foveal structure and a permanent visual impairment.

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.

Effect of 60 kHz and 150 kHz Femtosecond Lasers on Corneal Stromal Bed Surfaces: A Comparative Study.

Purpose. To compare the effect of 60 kHz and 150 kHz femtosecond (FS) laser on the corneal stromal bed surfaces (SBS). Methods. Sixteen human donor corneal tissues unsuitable for transplantation were used. Anterior and posterior lamella was obtained using 60 kHz and 150 kHz FS laser. A standard depth of 400 µ m was set for anterior lamellar keratoplasty (ALK) and endothelial lamellar keratoplasty (ELK). The quality and smoothness of the SBS post-FS laser dissection were graded for statistics. Results. No intraoperative complications were found. The side cuts were straight, and the SBS appeared smoother in cuts obtained using 150 kHz. The average values of the SBS quality of the anterior lamellar cut were found to be 2.25 (±0.28) for 60 kHz and 3.125 (±0.25) for 150 kHz (P = 0.0039). Whereas, 2 (±0.4) for 60 kHz and 2.75 (±0.28) for 150 kHz (P = 0.0273) was the quality observed in endothelial cuts. No significant difference was found between anterior and posterior cuts performed using the same FS laser (60 kHz or 150 kHz) (P > 0.05). Conclusions. The 60 kHz and 150 kHz FS lasers are equally effective in performing lamellar dissection for ALK and ELK. 150 kHz FS laser allows a tighter spot and layer separation which creates a slightly smoother SBS.

Health status and patient satisfaction after corneal graft: results from the corneal transplant epidemiological study.

Purpose. To evaluate effects of corneal transplantation on the health-related quality of life and patients' satisfaction. Methods. Patients scheduled for elective penetrating or anterior lamellar keratoplasty completed by telephone interview the SF-12 Health Survey, before and one year after surgery, and a 6-item questionnaire on the satisfaction for graft outcomes. Results. The two questionnaires were answered by 1,223 patients. Transplantation did not influence the PCS-12 in males (ES = -0.01) and had a negative effect in females (ES = -0.18). Both sexes improved their MCS-12 (ES = 0.18 and 0.23, resp.). The majority of patients (83.1%) were satisfied by the outcome of the graft. Conclusions. This is the first report on the use of the SF-12 and one of the few that assess quality of life in patients after corneal transplantation. We showed that grafting improves patients' health-related quality of life results of patients, influencing mental health (i.e., psychological attitude, social interaction, and emotions) with minor effects on physical health (limitation, pain, and vitality).

Sixty-kilohertz femtosecond laser-assisted endothelial keratoplasty: clinical results and stromal bed quality evaluation.

PURPOSE: To evaluate preliminary clinical results and lamellar and side cut obtained with a 60-kHz femtosecond laser (IntraLase) using a new software designed to create penetrating cuts for keratoplasty to perform the donor and recipient dissection in femtosecond laser-assisted endothelial keratoplasty. DESIGN: Prospective interventional case series. METHODS: A femtosecond laser set in a raster spot pattern was used to create the posterior lamellar dissection and posterior side cut in 4 donor corneas and in 4 recipient human eyes of 4 patients with endothelial decompensation. The laser cut was performed to obtain a 150-µm thick and 9-mm wide posterior lamellar disk from the donor and the recipient eyes. Postoperatively, patients underwent slit-lamp examination and Snellen visual acuity evaluation, Visante optical coherence tomography, optical pachymetry, and endothelial microscopy analysis. Three residual donor corneas were analyzed by scanning electron microscopy and transmission electron microscopy to observe the stromal bed surface, the side cut, and the effects of the laser dissection on the cornea ultrastructure. MAIN OUTCOME MEASURES: Thickness of the implanted donor lamella, adhesion and clarity of the transplanted cornea in the postoperative follow-up, and smoothness of the interface. RESULTS: All the patients showed good adhesion and fit of the donor disk to the recipient and a circle side cut observed at the slit-lamp examination. Visante optical coherence tomography evaluation confirmed the adhesion and the precalibrated thickness of the implanted lamella. A good corneal transparency was achieved within the first 2-3 weeks. The scanning electron microscopy analysis showed a smooth stromal residual surface and a precise side cut. The transmission electron microscopy images showed that the laser randomly modified the structural design of the collagen fibers for approximately 10-µm depth, although below a regular stromal structure was maintained. CONCLUSIONS: The 60-kHz IntraLase femtosecond laser creates a smooth stromal bed and precise side cut for endothelial keratoplasty. The posterior lamellar cut performed at the same depth in both the donor and the recipient makes it possible to create a corneal disk from the donor that fits exactly with the cut in the recipient.