Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population.

Purpose: To assess real-world clinical outcomes and safety of the Clareon® intraocular lens (IOL) and AutonoMe® automated preloaded delivery system in an Indian population. Patients and methods: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons' satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). Results: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and -0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. Conclusion: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.

"Air-Assisted" Donor Lenticule Insertion in Descemet Stripping Endothelial Keratoplasty in Aphakia With Large Iris Defect and Without Posterior Capsular Support.

PURPOSE: The purpose of this study was to report a novel technique of donor lenticule insertion in Descemet stripping endothelial keratoplasty (DSEK) in aphakic corneal edema with large iris defect and without any posterior capsular support. METHODS: This was a retrospective consecutive interventional case series. Clinical records of ten 1-eyed aphakic patients with corneal edema with large iris defect and no capsular support who underwent air-assisted donor lenticule insertion in DSEK were evaluated. After making 6.0- to 6.5-mm sclerocorneal tunnel and 2 side ports, limited anterior vitrectomy was performed if required. Then, Descemetorhexis was performed under air through side ports. Manually dissected donor lenticule was inserted into the anterior chamber under full-chamber air by a 30-G needle push-in technique. Further air tamponade was given if necessary. No fluid-air exchange was performed. The patient was kept on the same operating table for at least 1 hour and then shifted. Graft attachments in early postoperative period, corrected distant visual acuity, and endothelial cell density after 3, 6, and 12 months were analyzed. RESULTS: The mean postoperative follow-up period was 19.2 ± 6.7 months. There was no donor dislocation in this small group. All patients achieved a corrected distant visual acuity of 0.70 (20/100) after 3 months and maintained until 12 months. The endothelial cell density at 3 months (n = 8) was 2028 ± 151/mm 2 , at 6 months (n = 7) 1776 ± 198/mm 2 , and at 12 months (n = 7) 1721 ± 172/mm 2 . The corresponding endothelial cell loss was 25.8% ± 5.6%, 34.4% ± 5.1%, and 37.8% ± 7.1%, respectively. One graft failed after 15 months. CONCLUSIONS: "Air-assisted" donor lenticule insertion in DSEK is a safe surgical technique in aphakic patients with corneal edema with large iris defect and no capsular support.

Outcomes of Descemet Membrane Endothelial Keratoplasty Using Cornea From Elderly Donors Aged 80 Years and Older: In the Aftermath of Current Donor Shortage.

PURPOSE: The purpose of this study was to report the outcomes of Descemet membrane endothelial keratoplasty (DMEK) using corneas from elderly donors aged 80 years and older. METHODS: Eighty eyes of 78 patients who underwent DMEK-only or DMEK combined with cataract extraction (triple-DMEK) with surgeon-prepared graft between April 2016 and March 2020 were reviewed. Corrected distance visual acuity, endothelial cell density (ECD), and endothelial cell loss after 6 months, 1 year, and 2 years were analyzed. RESULTS: The mean donor age was 83.6 ± 3.7 years (range: 80-100 years), and the mean donor ECD was 2889 ± 177 cells/mm 2 (range: 2604-3460 cells/mm 2 ). The mean recipient age was 67.2 ± 6.9 years (range: 60-89 years), and the mean follow-up was 21 ± 11 months (range: 6-52 months). The mean corrected distance visual acuity improved from a preoperative value of 1.36 ± 0.67 logarithm of the minimum angle of resolution to 0.22 ± 0.18 at 6 months (n = 75), 0.21 ± 0.2 at 1 year (n = 64), and 0.23 ± 0.3 logarithm of the minimum angle of resolution at 2 years (n = 41), respectively ( P < 0.001). In 72 eyes (96%), the graft remained transparent until the last follow-up visit. The mean postoperative ECD was 2073 ±336 (n = 75), 1951 ± 379 (n = 65), and 1807 ± 431 cells/mm 2 (n = 41) at 6 months, 1 year, and 2 years, respectively. Five eyes (6.7%) had donor detachments of which 4 required rebubbling. Two grafts failed after 1 year, and 2 eyes (2.6%) had graft rejection, of which 1 eye was reverted successfully by medical management. CONCLUSIONS: Cornea from elderly donors aged 80 years and older with good selection criteria may be considered for DMEK with successful outcomes. For India and other countries with unmet tissue needs, every best single cornea counts.

Marking DMEK Grafts Using Bandage Contact Lens Interface Technique: Doubling the Utilization During the Acute Shortage of Donor Corneas.

PURPOSE: The purpose of this study was to describe a novel bandage contact lens (BCL) interface technique for marking the Descemet membrane endothelial keratoplasty (DMEK) graft so that a single donor cornea can be used effectively for 2 recipients during acute shortage. METHODS: This was a retrospective comparative case series. In group A, 37 eyes underwent DMEK using a graft marked by the ?BCL interface technique" that was compared with 49 conventional DMEK grafts marked through the stromal window (group B). In group A, a resized BCL with a central 3-mm hole with the concavity up was placed between the stroma and peeled-off DM. This BCL with DM was flipped for S-stamping on the DM side. Final trephination was performed on a second Teflon block. The remaining anterior lamellar tissues of group A were used on the same day for other keratoplasty procedures. Endothelial cell density (ECD) and endothelial cell loss between the 2 groups were compared after 3 and 6 months. RESULTS: The ECD at 3 months in group A (n = 35) versus group B (n = 45) was 2228 ± 270/mm2 versus 2302 ± 254/mm2 (P = 0.48), and the ECD at 6 months (n = 23 and 22) was 2058 ± 324/mm2 versus 2118 ± 260/mm2 (P = 0.72). The corresponding endothelial cell loss was 23.3% ± 6.8% versus 20.3% ± 6.1% (P = 0.18) at 3 months and 29.1% ± 8.4% versus 26.7% ± 8.0% (P = 0.34) at 6 months. Among anterior tissues of group A, 17 (45.9%) were used for deep anterior lamellar keratoplasty, 18 (48.6%) were used for larger therapeutic and tectonic grafts, and 2 were used as keratoprosthesis carriers. Donor detachment rate (8.6% vs. 8.9%) was similar in both groups without primary graft failures. CONCLUSIONS: The BCL interface technique is a simple and safe technique for stamping DMEK grafts. Anterior corneal tissues can be used for additional keratoplasties during donor shortage.

Acute interface infectious keratitis with multidrug resistant Klebsiella and Escherichia Coli following deep anterior lamellar keratoplasty.

Acute interface infectious keratitis (AIIK) is a rare and devastating complication following lamellar keratoplasty. Here, we report a case of AIIK following deep anterior lamellar keratoplasty (DALK) caused by double gram-negative bacilli and required urgent therapeutic penetrating keratoplasty (TPK). Microbiology revealed co-infection with Klebsiella and E. Coli sensitive only to colistin. Donor rim culture also grew Klebsiella. TPK was successful in controlling the infection and the patient responded to topical fortified amikacin and ciprofloxacin. Since optical quality tissue was used, the patient regained 20/40 vision postoperatively. This report highlights that immediate TPK and intense antimicrobial therapy can salvage these eyes with good visual outcome.

Recurrent cystoid macular edema following Boston keratoprosthesis type-II implantation: A treatment option.

A 68-year-old woman with end-stage Stevens-Johnson syndrome developed cystoid macular edema (CME) 3 months following Boston keratoprosthesis type II (KPro-II) implantation and treated with single-dose injection of triamcinolone acetonide (TA) in the inferior peribulbar region. After 14 days, CME resolved completely, and she regained 20/30 vision. Seven months later, she developed recurrent CME. She was again treated with a similar peribulbar injection of TA. CME was resolved completely after 2 weeks with full visual and anatomical recovery. Here, we present a case of recurrent CME following KPro-II implantation responsive to peribulbar injection of TA, which may be the only effective treatment option.

Overall clinical outcomes of Descemet membrane endothelial keratoplasty in 600 consecutive eyes: A large retrospective case series.

Purpose: To analyze the overall clinical outcomes of Descemet membrane endothelial keratoplasty (DMEK) in 600 consecutive cases. Methods: Retrospective, consecutive interventional case series operated by a single surgeon. Six hundred consecutive eyes of 524 patients with endothelial dysfunctions of different etiologies scheduled for DMEK were included in this study. All donor tissues were prepared by the operating surgeon during the procedure, using McCarey Kaufman medium or Cornisol-preserved cornea with endothelial cell density (ECD) of ≥2500 cells/mm2. Indications, postoperative best spectacle-corrected visual acuity (BSCVA), ECD, endothelial cell loss (ECL), and complications were analyzed postoperatively between 3 months and 2 years. Results: The commonest indication was post-cataract corneal edema/bullous keratopathy in 262 (43.7%) eyes followed by Fuchs' endothelial corneal dystrophy 218 (36.3%). Vision affected comorbidities were present in 91 (15.2%) eyes. In phakic eyes with cataract (222; 37%), DMEK was combined with cataract surgery (Triple-DMEK). BSCVA of ≥20/25 was achieved in 41.0%, 46.4%, 49.2%, and 48.7% of eyes at 3, 6, 12, and 24 months, respectively and stabilized at 6 months (P = 0.54). Mean ECD decreased from 2884 ± 178 cells/mm2 (n = 600) before surgery to 2223 ± 321 (n = 597), 2099 ± 354 (n = 524), 1918 ± 373 (n = 374), and 1772 ± 439 cells/mm2 (n = 158) at 3, 6, 12, and 24 months respectively. The corresponding mean ECL was 22.9 ± 11.4%, 27.2 ± 12.4%, 33.5 ± 13.0%, and 38.6 ± 14.3%, respectively (P < 0.05 for all-time points). The commonest complication was DM detachment in 59 (9.8%) eyes of which 23 (3.8%) eyes required rebubbling. Three (0.5%) eyes had primary graft failure. Endothelial rejection occurred in 7 (1.2%) eyes until the last follow-up. Conclusion: DMEK is a safe and effective procedure in different types of endothelial diseases with encouraging surgical and clinical outcomes. Complications are less and ECL percentage up to 2 years is acceptable.

Clinical Outcomes and Endothelial Cell Density After Descemet Membrane Endothelial Keratoplasty Using Peripherally-trephinated Donor Tissue (DMEK-pD) in Fuchs Endothelial Corneal Dystrophy.

PURPOSE: To evaluate the clinical outcomes and endothelial cell density (ECD) after Descemet membrane endothelial keratoplasty using peripherally trephinated donor tissue (DMEK-pD) and compare with DMEK using centrally trephinated donor tissue (DMEK-cD) in patients with Fuchs endothelial corneal dystrophy (FECD). METHODS: This was a prospective comparative interventional case series. One hundred twenty-five eyes of 110 patients with FECD and cataract who underwent either DMEK-pD (n = 60) or DMEK-cD (n = 65) combined with phacoemulsification, between June 2016 and November 2018, were included. Preoperative and postoperative best spectacle-corrected visual acuity (BSCVA) and ECD were recorded at 6 months and 1 year. RESULTS: All eyes had visually symptomatic FECD and cataract with a preoperative mean BSCVA of 1.03 logarithm of the minimum angle of resolution in both groups. Baseline donor mean ECD was 2944 ± 201 and 2907 ± 173 cells/mm in the DMEK-pD and DMEK-cD groups, respectively (P = 0.12). BSCVA improvement was comparable at 6 months and 1 year (P = 0.23 and P = 0.34). Mean ECD recorded after 6 months and 1 year was significantly higher in the DMEK-pD group than in the DMEK-cD group: 2508 ± 201 versus 2084 ± 298 cells/mm (P < 0.01) and 2338 ± 256 versus 1907 ± 339 cells/mm (P < 0.01), respectively. Complication rates were similar in both groups. CONCLUSIONS: DMEK-pD exhibited similar clinical outcomes with higher ECD compared with conventional DMEK-cD after 6 months and 1 year. The possibility of transplanting peripherally trephinated donor tissue in DMEK with more endothelial cells needs to be explored further in the future.

Descemet Membrane Endothelial Keratoplasty in Irreversible Corneal Edema Due to Herpes Simplex Virus Endotheliitis.

PURPOSE: To report the clinical outcome and postoperative course of Descemet membrane endothelial keratoplasty (DMEK) in irreversible corneal edema due to herpes simplex virus (HSV) endotheliitis. METHODS: This is a retrospective, noncomparative, interventional case series. Nineteen eyes of 19 patients underwent standard DMEK combined with cataract surgery (triple DMEK) between May 2016 and April 2018. All patients received perioperative oral acyclovir (ACV) and prednisolone. Patients were followed up on day 1, on day 7, at 1 month, and then at 3 monthly intervals. Preoperative and postoperative best spectacle-corrected visual acuity (BSCVA), graft clarity, pachymetry, and endothelial cell loss after 1 year were recorded. Postoperative complications and HSV recurrence were noted until the last follow-up visit. RESULTS: All eyes were phakic with variable grades of cataract with a preoperative BSCVA of 1.0 logarithm of the minimum angle of resolution or worse. The mean follow-up period was 19.3 ± 5.4 months. After 1 year, 14 (73.7%) eyes achieved a BSCVA of 0.3 or better. Seventeen (89.5%) patients had a clear graft at the last visit without any rejection episode. One graft failed after 16 months. After 3 months, the mean pachymetry reduced from 667.1 ± 62.1 to 512.8 ± 27.1 µm (P < 0.001). The mean endothelial cell loss after 1 year was 36.7 ± 13.4%. Three (15.8%) eyes had recurrence: one with recurrent endotheliitis and 2 with dendritic keratitis despite oral ACV, which responded to oral valacyclovir and ACV eye ointment. One patient had re-recurrence of endotheliitis after 20 months. CONCLUSIONS: DMEK in persistent corneal edema after HSV endotheliitis remains challenging but has encouraging outcomes. The postoperative course may be complicated by HSV recurrence. Prophylactic oral antivirals for 1 year or more and topical antivirals are useful for the prevention of recurrence.

Conjunctival stromal tumour (COST): anterior-segment OCT findings.

Conjunctival stromal tumour (COST) is a recently described rare conjunctival tumour of mesenchymal origin with only four publications describing a handful of cases thus far. In this report, we describe the anterior-segment optical coherence tomography (AS-OCT) characteristics in a case of COST for the first time, in addition to the clinical and histopathological characteristics. The AS-OCT showed an elevated, dome-shaped hyporeflective homogenous lesion in the conjunctival stroma lined by hyperreflective outer layer with mild posterior shadowing, consistent with histological description of a paucicellular tumour with large myxoid collagenous material inside. Immunohistochemistry showed positive CD34 and vimentin but negative S100 and smooth muscle actin, thereby differentiating it from conjunctival myxoma.

Recurrence of herpes simplex virus endotheliitis in a Descemet membrane endothelial keratoplasty graft: mimicking fungal interface infection.

Recurrence of herpes simplex virus (HSV) keratitis is a problem of keratoplasty and the prognosis is often poor in spite of oral acyclovir (ACV) prophylaxis. This 64-year-old woman was a known case of recurrent HSV endotheliitis with irreversible corneal oedema in the left eye for 2 years. She underwent Descemet membrane endothelial keratoplasty with intraocular lens implantation under perioperative oral ACV and prednisolone. After 4 weeks, her cornea cleared with the best-corrected vision of 6/9. After 2.5 months, she presented with sudden photophobia and visual loss. An increasing focal endothelial lesion was noticed even after oral ACV. Suspecting fungal interface infection, anterior chamber tap was done for PCR for panfungal and viruses. It was only positive for HSV. Oral ACV was changed to oral valacyclovir. The patient responded dramatically within 2 weeks, and after 12 weeks, the lesion disappeared completely, leaving behind a faint scar with 6/9 p vision. Oral valacyclovir, a prodrug of ACV, may work better than oral ACV.

Outcomes of Descemet Membrane Endothelial Keratoplasty (DMEK) Using Surgeon's Prepared Donor DM-Roll in Consecutive 100 Indian Eyes.

BACKGROUND: Descemet Membrane Endothelial Keratoplasty (DMEK) is now becoming the popular form of endothelial keratoplasty using only donor DM with healthy endothelium as true component lamellar corneal surgery. OBJECTIVE: To analyze the results of visual outcomes, endothelial cell loss and complications of Descemet membrane endothelial keratoplasty in first consecutive 100 Indian eyes. METHODS: 100 eyes of 95 consecutive patients with endothelial dysfunctions of different etiologies scheduled for DMEK, were included in this study. In each case, surgeon prepared tissue using McCarey Kaufman medium- or Cornisol-preserved donor cornea with a cell count of ≥2500 cells/mm2. Surgical complications, Best Spectacle Corrected Visual Acuity (BSCVA); Endothelial Cell Density (ECD) and Endothelial Cell Loss (ECL) were analyzed for each patient after a minimum follow-up of three months. RESULTS: The Main indication was pseudophakic corneal edema or bullous keratopathy in 52 (52%) eyes. 38 (38%) eyes had Fuchs' dystrophy with various grades of cataract. In 43 phakic eyes, DMEK was combined with cataract surgery and intraocular lens implantation. Mean DM-roll preparation time was 7.5 ± 2.8 min and in 3 eyes, DM-graft were damaged. After 3-months, BSCVA was ≥20/25 in 57 (57.6%) cases. Mean ECD was 2123 ± 438/mm2 (range: 976 - 3208/ mm2) and the mean endothelial cell loss after 3-months was 26.92 ± 13.40 (range: 4.90 - 66.6%). Partial DM detachment occurred in 8 (8.0%) eyes and rebubbling required in 4 eyes. Iatrogenic primary graft failure occurred in one eye. CONCLUSION: Descemet membrane endothelial keratoplasty is a safe and effective procedure in several types of endothelial diseases among Indian patients with encouraging surgical and visual outcomes. Complications are less and endothelial cell loss percentage is acceptable.

Outcomes of the Boston Type I Keratoprosthesis as the Primary Penetrating Corneal Procedure.

PURPOSE: To report the outcomes of the Boston type I keratoprosthesis (KPro) as the primary penetrating corneal procedure. METHODS: In this retrospective review of all KPro procedures performed by 2 surgeons from May 1, 2004, to December 31, 2015, indications and outcomes were compared between KPros performed as the primary keratoplasty procedure (primary KPro) versus after failed keratoplasty (previous keratoplasty). RESULTS: A total of 262 KPros were implanted in 231 eyes, including 67 primary KPro procedures. The most common indications for primary KPros were corneal scarring/vascularization (43%), Stevens-Johnson syndrome (22%), and chemical/thermal injury (22%). Although preoperative corrected distance visual acuity (CDVA) was similar in the 2 groups (P = 0.36), a significantly higher proportion of the eyes in the primary KPro group had a CDVA ≥ 20/200 each of the first 4 years after surgery (all P ≤ 0.023). The most common postoperative complications in the primary KPro and previous keratoplasty groups were retroprosthetic membrane (40% vs. 51%, P = 0.15), persistent epithelial defect (37% vs. 24%, P = 0.05), and elevated intraocular pressure, which was the only complication significantly more common in either group (31% vs. 18%, P = 0.03). No difference in KPro retention was observed between the 2 groups (P = 0.63). CONCLUSIONS: In the setting of preexisting ocular comorbidities in which PK is associated with poor outcomes and KPros have been associated with an increased incidence of postoperative complications, primary KPro is associated with significantly greater % of eyes with CDVA ≥ 20/200 in the first 4 years. However, given a significantly higher incidence of postoperative intraocular pressure elevation in these eyes, longer follow-up is needed to determine whether the difference in CDVA is maintained.

Comparison of seropositivity of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and syphilis among Hospital Cornea Retrieval Programme-Donors versus voluntary cornea donors at a large eye bank in Eastern India.

PURPOSE: To compare the serology profile of donors from Hospital Cornea Retrieval Programme-donors (HCRP-D) and voluntary cornea donors (VC-D) from a large eye bank in Eastern India. METHODS: This is a retrospective analysis of donor details from January 2011 to December 2016. Donor demographics, cause of death, and serology reports were compiled. Postmortem blood was tested for human immunodeficiency virus 1 and 2 (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis using government-approved kits as per the National Programme for Control of Blindness Standards of Eye Banking. Donors for whom serology was not possible were excluded. RESULTS: A total of 4300 of 4353 donors were included of which 74.3% were hospital donors and 25.7% were voluntary donors. A total of 93 (2.2%) donors with 94 seropositive reports were noted: 79 (84.9%) from HCRP-D and 14 (15.1%) from VC-D which was statistically significantly higher (P = 0.02). Among seropositive reports, HIV, HBV, HCV, and syphilis accounted for 12 (12.8%), 38 (40.4%), 36 (38.3%), and eight (8.5%), respectively. There was no correlation between the cause of death and seropositivity. A statistically significant decreasing trend in seroprevalence among hospital donors was observed over the years (5.3% in 2011 to 1.4% in 2016; P = 0.004). Two (0.47%) of 421 hospital donors with prior negative serology were found to be seropositive. CONCLUSION: Seropositive rates are significantly higher among hospital donors in spite of medical prescreening compared to nonscreened voluntary donors. Serology should be repeated even when prior reports are available.