Prospective Randomized Clinical Trial Evaluating Efficacy and Safety of A New Ophthalmic Viscosurgical Device In Patients Undergoing Cataract Surgery.

PURPOSE: To evaluate the efficacy and safety of Bio-Hyalur LVD compared to Viscoat® ophthalmic viscosurgical device (OVD) in patients undergoing routine cataract surgery. SETTING: Two tertiary eye care hospitals in Italy. DESIGN: Prospective randomized clinical trial. METHODS: This study compared the outcomes of Bio-Hyalur LVD versus Viscoat® ophthalmic viscosurgical device in patients undergoing standard cataract surgery with phacoemulsification and intraocular lens implantation from January 2021 to April 2022. The primary outcome was mean change in IOP at 6 hours. Secondary outcomes included 1-, 7-, 30- and 90-day mean intraocular pressure (IOP), 7-, 30- and 90-day best corrected visual acuity, endothelial cell density (ECD), change in central corneal thickness (CCT) and complications including intraocular inflammation. RESULTS: A total of 84 eyes of 84 patients (n = 41 in the Bio-Hyalur LVD group and n = 43 in the Viscoat group) were screened, enrolled, randomized, and included in the analysis. Mean change in IOP was significantly higher in the Viscoat group than in the Bio-Hyalur LVD group 6 hours (p = 0.034), 7 days (p < 0.001), 30 days (p < 0.001) and 90 days (p = 0.003) postoperatively. Mean change in UDVA and CDVA was significantly higher in the Bio-Hyalur LVD group 30 and 90 after surgery. No significant differences in ECD, CCT and complication rates were observed between groups at any time point. CONCLUSION: Bio-Hyalur LVD OVD is safe and effective for use in patients undergoing routine cataract surgery. Bio-Hyalur LVD OVD did not confer a higher risk of postoperative increase in IOP.

Factors predictive of cystoid macular oedema following endothelial keratoplasty: a single-centre review of 2233 cases.

AIMS: To describe the incidence of postoperative cystoid macular oedema (CMO) after endothelial keratoplasty (EK) and to identify its contributory risk factors. METHODS: 2233 patients undergoing EK at Ospedali Privati Forlì 'Villa Igea', between January 2005 to October 2018 for Descemet stripping automated endothelial keratoplasty (DSAEK) and June 2014 to August 2018 for Descemet membrane endothelial keratoplasty (DMEK) with a minimum follow-up of 18 months were evaluated. Univariate and multivariate analyses were conducted to identify and quantify contributory risk factors. Receiver operating characteristic (ROC) curve analysis were performed to determine ideal cut-off points of continuous variables. RESULTS: CMO was identified in 2.82% (n=63) of the cases. CMO occurred in 2.36% of DSAEK eyes and in 5.56% of DMEK eyes (p=0.001). Average onset of CMO was 4.27±6.63 months (range: 1-34 months) postoperatively. Compared with those who did not develop CMO, a higher proportion of patients in the CMO group had diabetes (24.2% vs 9.8%, p<0.001) (OR=3.16, 95% CI: 1.72 to 5.81, p<0.001), a higher proportion of patients who underwent DMEK rather than DSAEK (28.6% vs 14.1%, p=0.001) (OR=2.42, 95% CI: 1.35 to 4.33, p=0.003) and were older (70.5±10.0 vs 67.1±14.3 years, p=0.01). Using the cut-off of 67 years as identified by ROC curve analysis, subjects aged >67 years (OR=2.35, 95% CI: 1.30 to 4.26, p=0.005) were more likely to develop CMO. There were no other significant differences between the groups. CONCLUSIONS: Older age (>67 years), diabetes mellitus and DMEK have been identified as independent risk factors for postoperative CMO following EK. Close observation is necessary during the first postoperative year after EK, particularly in patients with risk factors.

Outcomes of cataract surgery with toric intraocular lens implantation after keratoplasty.

PURPOSE: To evaluate the efficacy and predictability of cataract extraction with toric intraocular lens (IOL) implantation after deep anterior lamellar keratoplasty (DALK) or mushroom penetrating keratoplasty (PK). SETTING: Villa Igea Hospital, Forlì, Italy. DESIGN: Prospective case series. METHODS: Toric IOL implantation was offered to patients with cataract, corneal astigmatism >1.5 diopters (D) and regular central corneal topography after complete suture removal. Phacoemulsification was performed through a 2.4 mm scleral tunnel and an enVista monofocal toric MX60T or Eyecryl monofocal toric IOL was inserted in the capsular bag. Main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, total prediction error, and IOL misalignment. RESULTS: 37 consecutive patients who had previously undergone either DALK (n = 27, 73%) or 2-piece mushroom PK (n = 10, 27%) were included. All patients completed the 6-month follow-up. The mean toric IOL power was 5.3 ± 1.1 D. Both UDVA and CDVA significantly improved (from 1.02 ± 0.27 to 0.46 ± 0.31 logMAR and from 0.65 ± 0.27 to 0.11 ± 0.12 logMAR, respectively; P < .001). 20 eyes (54%) reached UDVA ≥20/40, whereas 35 eyes (95%) reached a CDVA ≥20/40. Final refractive astigmatism was 0.93 ± 0.87 D, with 35 eyes (95%) within 2 D. Prediction error was ≤1 D in 18 eyes (49%). Absolute IOL misalignment was 3.3 ± 3.5 degrees. CONCLUSIONS: Toric IOL implantation in postkeratoplasty eyes allowed reduction of refractive astigmatism to predictably low levels with concomitant improved visual outcomes.

Accuracy of intraocular lens power calculation for cataract surgery after deep anterior lamellar keratoplasty.

BACKGROUND: The purpose of this study was to assess the accuracy of intraocular lens power (IOL) formulas for cataract surgery after deep anterior lamellar keratoplasty (DALK). METHODS: This retrospective study included eyes which had previously undergone DALK and underwent standard phacoemulsification with monofocal IOL implantation between January 2012 and January 2021 at Ospedali Privati Forlì "Villa Igea" (Forlì, Italy). The predicted spherical equivalent (SE) was calculated using the Barrett Universal II, Emmetropia Verifying Optical (EVO), Haigis, Hoffer Q, Hoffer QST, Holladay 1, Holladay II, Kane and SRK/T formulas. Prediction error (PE) was calculated as the actual postoperative SE refraction minus the SE predicted refraction. RESULTS: Eighty-two eyes of 82 patients were included. The mean PE was negative using all formulas. Friedman test revealed a statistically significant difference of the median absolute PE (MedAE) among the different IOL formulas (P = 0.005). On the basis of the MedAE, the formulas were ranked as follows: SRK/T (0.805 D), Kane (0.810 D), EVO (0.845 D), Hoffer QST (0.847 D), Barrett (0.895 D), Holladay 1 (0.915 D), Haigis (1.010 D) and Hoffer Q (1.070 D) formulas. CONCLUSIONS: All formulas had a tendency towards a myopic refractive shift in post-DALK eyes. Although the SRK/T, Kane, EVO and Hoffer QST formulas were more accurate, predictability of refractive outcomes was lower than in virgin eyes.

Interface Drainage and Antimicrobial Irrigation Avoid Repeat Keratoplasty for Post-DSAEK Cold Interface Abscess.

PURPOSE: To describe a surgical technique for the diagnosis and treatment of post-Descemet stripping automated endothelial keratoplasty (DSAEK) infectious interface keratitis presenting as a cold abscess. METHODS: This study included 2 eyes of 2 patients that developed delayed-onset interface infections after DSAEK. Through an anterior keratotomy, diagnostic samples for microbial culture and histopathology examination were collected, and empiric antibiotic therapy was delivered directly to the site of the infection at the graft-host interface. RESULTS: In both cases, microbiological examinations confirmed a fungal etiology consistent with Candida. Resolution of infection was achieved, and no signs of posterior segment involvement or recurrence of infection were observed. Both corneas remained clear with final visual acuity of 20/25 and 20/32. No case required additional surgical intervention or repeat keratoplasty after more than 15 months of follow-up. CONCLUSIONS: Interface drainage with antimicrobial irrigation may be considered for the management of post-DSAEK interface infections presenting as a peripheral cold abscess. By avoiding intraocular seeding of infectious pathogens, the anterior approach can achieve clinical resolution of infection, maintain visual function, and preserve the DSAEK graft, thereby obviating the need for a therapeutic keratoplasty.

Pneumatic Dissection for Large-Diameter (9-mm) Deep Anterior Lamellar Keratoplasty in Eyes With Previous Anterior Lamellar Keratoplasty.

PURPOSE: To evaluate the surgical and 3-year clinical outcomes of modified big-bubble 9-mm deep anterior lamellar keratoplasty (DALK) in eyes with previous ALK (ALK). METHODS: In this interventional case series, 21 consecutive eyes with unsatisfactory vision after ALK (superficial ALK n = 9; laser-assisted ALK n = 7; and epikeratophakia n = 5) underwent large-diameter (9-mm) DALK. The surgery involved deep trephination based on the anterior segment optical coherence tomography pachymetry measurement at 9-mm diameter, pneumatic dissection from the base of the trephination and limited stromal clearance of the optical zone (6 mm). Main outcome measures were success rates of pneumatic dissection, best spectacle-corrected visual acuity, and complication rates. RESULTS: Pneumatic dissection with type 1 bubble formation succeeded in 19 (90%) eyes. In the 2 remaining cases, the 6-mm optical zone was cleared by manual dissection. Perforation occurred in one of the latter cases; no procedure was converted to penetrating keratoplasty. One month after complete suture removal, the preoperative mean best spectacle-corrected visual acuity (0.75 ± 0.23 logMAR) improved to 0.09 ± 0.10 logMAR (P < 0.001) and remained stable up to 3 years after surgery. At the final follow-up, refractive astigmatism was ≤4.5 and <6 D in 20 (95%) and 21 (100%) eyes, respectively. Stromal rejection was observed in 2 eyes (10%) and was treated successfully with steroids. CONCLUSIONS: Even in eyes with previous ALK, pneumatic dissection can be achieved through a modified DALK technique with a low risk of complications and excellent visual and refractive outcomes.

Three-Year Outcomes of Tri-Folded Endothelium-In Descemet Membrane Endothelial Keratoplasty With Pull-Through Technique.

PURPOSE: To assess the 3-year outcomes of tri-folded endothelium-in Descemet membrane endothelial keratoplasty (DMEK) using bimanual pull-through delivery technique. DESIGN: Interventional case series. METHODS: In this single-center study, we included 153 consecutive eyes that underwent DMEK for various indications (Fuchs endothelial corneal dystrophy [FECD]: n = 111; bullous keratopathy [BK]: n = 24; and failed graft: n = 18). DMEK grafts were loaded into a disposable cartridge in a tri-folded, endothelium-in configuration and delivered using bimanual pull-through technique. Main outcome measures were graft preparation and unfolding times, best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), and graft survival. RESULTS: Mean graft preparation time was 5.9 ± 1.1 minutes; and mean graft unfolding time was 2.9 ± 0.9 minutes. Excluding eyes with comorbidities, logarithm of minimum angle of resolution BSCVA improved significantly from baseline preoperative values of 0.92 ± 0.58 to 0.02 ± 0.07 at 1 year (P < .001) and remained stable up to 3 years. Mean postoperative ECD decreased significantly (P < .001) from eye bank values to 1,818 ± 362, 1,675 ± 372, and 1,580 ± 423 cells/mm2 at 1, 2, and 3 years, respectively. No significant differences in ECD were observed between eyes with FECD and BK, but ECD was significantly lower in eyes with previous failed graft (P < .05). Three-year cumulative graft survival rate was significantly (P < .001) lower for eyes with previous failed graft (71%) than for FECD (97%) and BK (92%). CONCLUSIONS: Tri-folded endothelium-in DMEK requires minimal time for graft unfolding, which is the surgical step considered most challenging by corneal surgeons. Visual outcomes and complication rates are not adversely affected by the modification of the surgical technique.

Initial High-Dose Prophylaxis and Extended Taper for Mushroom Keratoplasty in Vascularized Herpetic Scars.

PURPOSE: To report the outcomes of initial high-dose and extended taper of antiviral and steroid prophylaxis for the treatment of eyes with high-risk vascularized herpetic corneal scars that underwent 2-piece mushroom keratoplasty (MK). DESIGN: Prospective interventional case series. METHODS: In this single-center study, 52 consecutive eyes with vascularized (≥2 quadrants) herpetic corneal scars underwent 2-piece microkeratome-assisted MK. Initial high-dose and extended taper of combined oral and topical antiviral and steroid prophylaxis was administered. Outcome measures were best spectacle-corrected visual acuity (BSCVA), refractive astigmatism (RA), endothelial cell density, immunologic rejection, herpetic recurrence, and graft failure rates. RESULTS: Excluding patients with vision-impairing comorbidities, baseline BSCVA (1.73 ± 0.67 logMAR) significantly improved annually during the first 2 years (P < .001, P = .016), reaching 0.17 ± 0.18 logMAR at year 2, and remaining stable up to 10 years (P = .662). At 2 years, 86% of eyes saw ≥20/40, 55% saw ≥20/25, and 18% saw ≥20/20 Snellen BSCVA. RA exceeded 4.5 diopters in 7% of cases after wound revision for high-degree astigmatism in 7 cases. Endothelial cell loss was 40.9% at 1 year with an annual decline of 3.1% over 10 years. The 10-year cumulative risk for immunologic rejection, herpetic recurrence, and graft failure was 9.7%, 7.8%, and 7.6%, respectively. CONCLUSIONS: Initial high dose and extended taper of antiviral and steroid prophylaxis for MK in high-risk, vascularized herpetic corneal scars achieves clinical outcomes that remain stable for up to 10 years after surgery with minimal risk of immunologic rejection, herpetic recurrence and graft failure.