Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

Management of aniridia and iris defects: an update on iris prosthesis options.

PURPOSE OF REVIEW: This review examines the advantages and limitations of the various iris prostheses as treatment for aniridia. RECENT FINDINGS: Multiple prosthetic iris devices have been developed for implantation in eyes with aniridia. However, none is currently approved for use in the USA. SUMMARY: Aniridia can be congenital or traumatic in etiology and can lead to glare and other visual disturbances. Treatment options include colored contact lenses, corneal tattooing, and corneal stromal implants, although these carry significant risks of infection and corneal scarring. Prosthetic iris devices can often simultaneously treat aphakia or cataract as well as aniridia, and various models are currently available around the world from Morcher GMBH (Kapuzinerweg 12, 70374 Stuttgart, Germany), Ophtec USA Inc. (6421 Congress Ave Suite 12, Boca Raton, FL 33487, USA) and HumanOptics (Erlangen, Germany). Surgical planning and technique are important in optimizing the safety of these devices. The CustomFlex iris prosthesis from HumanOptics can be implanted within the capsular bag or ciliary sulcus with scleral fixation and offers excellent cosmetic outcomes. At present, the HumanOptics prosthetic iris is being investigated in a multicenter clinical trial.

Persistent Mydriasis Following Gonioscopy-Assisted Transluminal Trabeculotomy.

Herein we describe 2 cases of persistent mydriasis after gonioscopy-assisted transluminal trabeculotomy for open angle glaucoma. Both surgeries were uneventful, but the patients experienced postoperative hyphema and intraocular pressure elevation. They then developed persistent fixed and dilated pupils resistant to pilocarpine that led to intolerable photosensitivity and glare. An iris cerclage pupilloplasty was performed with adequate relief of symptoms in one case.

Improved Signs and Symptoms of Dry Eye Disease for Restasis® Patients Following a Single Tearcare® Treatment: Phase 2 of the SAHARA Study.

Purpose: To evaluate dry eye disease (DED) signs and symptoms six months after a single treatment with Localized Heat Therapy (LHT) (TearCare, Sight Sciences) for patients previously treated for six months with cyclosporine (0.05%) ophthalmic emulsion (CsA) BID (Restasis, Allergan). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, cross-over, six month extension to the SAHARA randomized, controlled trial (RCT). Included patients were those randomized to CsA in Phase 1 of the SAHARA RCT. Methods: This was the second phase of the SAHARA RCT in which, following the 6-month endpoint, all patients that had been randomized to CsA discontinued CsA and were treated with LHT and subsequently followed for an additional six months. Outcome measures at 12 months for CsA patients crossed over to LHT included TBUT, OSDI and MGSS. Results: One hundred and sixty-one patients (322 eyes) were analyzed. Mean (SD) baseline TBUT prior to CsA was 4.4 (1.2) seconds, 5.6 (2.6) at 6 months which improved to 6.6 (3.2) and 6.1 (2.8) seconds (both P < 0.001) at 9 and 12 months (3, 6 months post LHT). Mean (SD) OSDI was 50.0 (14.9) at baseline and 34.2 (21.5) after CsA. With LHT at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P = 0.162 vs month 6, P < 0.0001 vs baseline). MGSS was 7.1 (3.2) at baseline, 13.3 (8.2) at the end of CsA treatment which improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months; both P <0.001. Conclusion: SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.

Pars plana vitrectomy and scleral-fixated intraocular lenses: comparison of Gore-Tex suture and flanged intrascleral haptic fixation techniques.

OBJECTIVE: To compare clinical outcomes of combined pars plana vitrectomy (PPV) and secondary scleral fixation of an intraocular lens (IOL) using Gore-Tex suture versus flanged intrascleral haptic fixation (FIHF) using double needles. DESIGN: Single-centre retrospective cohort series. PARTICIPANTS: Eyes undergoing PPV with simultaneous scleral fixation of an IOL. METHOD: Eyes that underwent fixation of a Bausch & Lomb Akreos AO60 or enVista MX60E IOL using Gore-Tex suture or a Tecnis ZA9003 or Zeiss CT LUCIA 602 IOL using FIHF were included. The primary outcome was change from baseline visual acuity to postoperative month 3. Secondary outcomes included deviation from refractive target aim and rates of postoperative complications. RESULTS: Seventy-nine eyes of 72 patients were included. Mean (±SD) follow-up was 16 ± 10.5 months (range, 4.5-45.2 months). Fifty-three eyes (67.1%) underwent Gore-Tex suture fixation, and 26 eyes (32.9%) underwent FIHF. Across all eyes, mean visual acuity improved from 1.30 ± 0.74 logMAR (20/399 Snellen equivalent) preoperatively to 0.36 ± 0.36 logMAR (20/45 Snellen equivalent) at 3 months (p < 0.001). No difference in visual acuity at month 3 was noted between the 2 techniques (p = 0.34). Mean deviation from refractive target aim was not significantly different between the Gore-Tex and FIHF groups (+0.14 ± 1.33 D vs -0.16 ± 0.88 D; p = 0.45). Reoperation rates were similar between groups (2 of 53 eyes in the Gore-Tex group vs 3 of 26 eyes in the FIHF group; p = 0.32). CONCLUSION: Combined PPV and scleral fixation of IOLs with Gore-Tex suture and FIHF resulted in similar improvements in visual acuity. No significant differences in refractive outcome and postoperative complication profiles were noted.

The Current State in the Diagnosis of Eyelid Margin Disease: A Clinical Review.

The eyelid margin is vital to ocular surface integrity. Much peer-reviewed literature has been established in eyelid margin inflammation, better known as blepharitis. The purpose is to review and understand the impact of eyelid margin disease. Anterior blepharitis causes inflammation at the eyelash base, ciliary follicles, and the palpebral skin. Posterior blepharitis occurs when there is inflammation with the posterior eyelid margin disease. In common usage, the term "blepharitis" used alone almost always refers to anterior blepharitis. Classification of eyelid margin disease should be based on etiopathogenesis, location, primary vs. secondary, and chronicity. Blepharitis has several etiopathologies (infectious, inflammatory, squamous). MGD can refer to the functional and/or structural problems with the MG. Meibomitis (or meibomianitis) occurs when there is inflammation associated with the MGD. The presence of blepharitis and/or MGD (with or without inflammation) can impact the ocular surface and thereby affect anterior segment and cataract surgeries. This review article evaluates the differential diagnoses of eyelid margin disease, including various forms of blepharitis, MGD, and meibomitis.

EYELID MARGIN DISEASE (BLEPHARITIS AND MEIBOMIAN GLAND DYSFUNCTION): CLINICAL REVIEW OF EVIDENCE-BASED AND EMERGING TREATMENTS.

ABSTRACT: Blepharitis is a common ophthalmic condition with multiple etiologies and no definitive, universal treatment. The treatment modalities for managing lid margin diseases vary depending on the disease's cause, location, and severity. For anterior blepharitis, management options include eyelid hygiene with warm compresses, eyelid scrubs, baby shampoo, and over-the-counter eyelid cleansers. Topical antibiotics and antibiotic-steroid combination drops/ointments for the eye and eyelid may accompany these. For posterior blepharitis/meibomian gland dysfunction (MGD), at-home warm compress or in-office administration of heat therapy/thermal pulsation treatment that aims to clear obstruction in the meibomian glands and restore meibum secretions to maintain a healthy tear film, are recommended. In addition to the above treatment strategies, various other compounds to manage lid margin diseases are in the late stages of development. This review summarizes the available treatment modalities or those in the pipeline for treating blepharitis and MGD.

Sutureless amniotic membrane ProKera for ocular surface disorders: short-term results.

OBJECTIVE: To evaluate the indications and outcomes of sutureless amniotic membrane transplant (AMT; ProKera) in the management of ocular surface disorders. METHODS: Chart review of patients who had ProKera (Bio-Tissue, Inc.) implantation for ocular surface disorders between June 2008 and May 2012 at 3 ophthalmology practices in Philadelphia, PA. The parameters evaluated included age, sex, indication for AMT, any other combined procedure, duration of retention of amniotic membrane, the effect of amniotic membrane on ocular surface healing, follow-up time, and complications. RESULTS: There were 35 eyes of 33 patients with a mean age of 68.2±19.5 years (range: 17-99 years). There were 25 male patients, and median follow-up was 110 days (mean: 164.6 days; range: 30-960 days). The indication for insertion of ProKera was nonhealing corneal ulcers of infective origin (group 1) in 9 eyes (25.7%), neurotrophic keratopathy (group 2) in 11 eyes (31.4%), chemical injury (group 3) in 5 eyes (14.3%), and other indications (group 4) in 10 eyes (28.6%). Complete or partial success was seen in a total of 44%, 64%, 80%, and 70% eyes in groups 1 to 4, respectively. Discomfort with the device was seen in 6 (17.1%) of 35 eyes, and recurrence of primary pathologic condition occurred in 5 (14.3%) of 35 eyes. CONCLUSION: ProKera treatment is easy to use and reasonably well tolerated, with moderate success in corneal ulcers and encouraging results in acute moderate chemical injury. Recurrence of primary pathologic condition is seen particularly associated with neurotrophic keratitis and dry eye syndrome.

Approach to a spontaneously ruptured posterior polar cataract.

A 61-year-old man presented with gradual blurring of vision and glare in both eyes for a couple of years, with worsening of the vision in his right eye over the past 2 months. He had no medical history of note. On clinical examination, his visual acuities were 20/80 in the right eye and 20/30 in the left eye, uncorrected. The cornea was clear, and the anterior chamber (AC) was deep in both eyes. He had bilateral mild nuclear sclerosis with round central onion-ring-like posterior opacities. The opacities measured approximately 2 mm in diameter and were marginally larger in the right eye than in the left eye (Figure 1JOURNAL/jcrs/04.03/02158034-202305000-00018/figure1/v/2023-04-20T184543Z/r/image-tiff). In addition, there were 2 curvilinear lines across the right posterior capsule (PC), one of which passed across the lens opacity (Figure 2JOURNAL/jcrs/04.03/02158034-202305000-00018/figure2/v/2023-04-20T184543Z/r/image-tiff). Fundus examination was normal in both eyes, and the vitreous was clear. Optical coherence tomography (OCT) of the macular and optic nerve in both eyes was normal. The endothelial cell count in both eyes exceeded 2000 cells/mm2. He had been told by a previous ophthalmologist to have bilateral cataracts and was now keen for surgery starting with the right eye. He works as a manager in a large company and is an avid golf player. He is emmetropic and wears spectacles for near work. Optical biometry using predicated posterior corneal astigmatism did not recommend a toric intraocular lens (IOL). He had done his internet research on IOL options and requested trifocal IOLs. What is your surgical plan for right cataract removal? Explain which IOL you would choose to implant.

Corneal Outcomes Following Cataract Surgery Using Ophthalmic Viscosurgical Devices Composed of Chondroitin Sulfate-Hyaluronic Acid: A Systematic Review and Meta-Analysis.

Background: Ophthalmic viscosurgical devices (OVDs) are commonly used during cataract surgery to protect the corneal endothelium. A systematic literature review and meta-analysis were conducted to assess the clinical evidence of OVDs composed of chondroitin sulfate-hyaluronic acid (CS-HA) versus other OVDs in maintaining endothelial cell density (ECD) and corneal thickness (CT). Methods: MEDLINE and EMBASE databases were searched from 2000 to 2020. Randomized controlled trials (RCTs, N ≥ 20 per group) comparing an OVD containing CS-HA (ie, VISCOAT®, DuoVisc® or DisCoVisc®) to any other OVD were included. The identified comparators were limited to the OVDs found in the literature, which included those composed of HA-only or hydroxypropyl methylcellulose (HPMC). Outcomes of focus included changes in ECD (baseline to 3 months) and CT (baseline to 24 hours). Meta-analyses were performed using R software, to assess mean differences (MD) in ECD and CT change between CS-HA OVDs and HA-only or HPMC OVDs. Results: A total of 966 abstracts were screened, and data were extracted from 12 RCTs. Meta-analyses using a random-effects model revealed significantly lower percent (%) decrease in ECD for CS-HA OVDs compared to both HA-only (MD: -4.10%; 95% CI: -5.81 to -2.40; p < 0.0001; 9 studies) and HPMC (MD: -6.47%; 95% CI: -10.41 to -2.52; p = 0.001; 2 studies) products. Similarly, % CT increase was significantly lower with CS-HA than with HA-only OVDs (MD: -3.22%; 95% CI: -6.24% to -0.20%; p = 0.04; 4 studies). However, there were no significant differences when comparing % CT change between CS-HA and HPMC OVDs (MD: 2.65%; 95% CI: -0.43% to 0.95%; p = 0.4; 2 studies). Conclusion: CS-HA OVDs lead to less postoperative loss of endothelial cells and may better protect corneal endothelium during cataract surgery, relative to other OVDs. Future randomized studies may be needed to solidify these findings.

Prior Contralateral Penetrating Keratoplasty Is a Risk Factor for Second Eye Graft Rejection.

AIMS: To determine whether prior penetrating keratoplasty (PK) in the contralateral eye increases risk of second eye PK graft rejection. METHODS: Cohort study of 593 consecutive PKs in transplant-naïve eyes (500 unilateral cases, 93 second eyes). Outcomes were compared between PKs performed in eyes with versus without a history of prior contralateral eye PK. Risks of rejection and failure were estimated using Cox proportional hazards models. RESULTS: Mean age was 53.7 ± 23.3 years; average follow-up was 4.00 ± 2.87 years. Rejection occurred in 211 (35.6%) grafts. The incidence of rejection was 34.0% in unilateral cases and 44.1% in second eyes with PK in the contralateral eye. Prior contralateral PK was a significant risk factor for graft rejection (HR = 1.42, 95% CI 1.01-2.01, p = .045). CONCLUSION: Contralateral PK is associated with increased risk of second eye graft rejection. Loss of ocular immune privilege is a possible mechanism.

Clinical diagnosis and management of Demodex blepharitis: the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH).

BACKGROUND: Twelve ocular surface disease experts convened to achieve consensus about Demodex blepharitis (DB) using a modified Delphi panel process. METHODS: Online surveys were administered using scaled, open-ended, true/false, and multiple-choice questions. Consensus for questions using a 1 to 9 Likert scale was predefined as median scores of 7-9 and 1-3. For other question types, consensus was achieved when 8 of 12 panellists agreed. Questions were randomized, and results of each survey informed the following survey. RESULTS: Twelve practitioners comprised the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). Following 3 surveys, experts agreed that DB is chronic (n = 11) and recurrent (n = 12) and is often misdiagnosed. Consensus was achieved regarding inflammation driving symptoms (median = 7; range 7-9), collarettes as the most common sign (n = 10) and pathognomonic for DB (median = 9; range 8-9), and itching as the most common symptom (n = 12). Panellists agreed that DB may be diagnosed based on collarettes, mites, and/or patient symptoms (n = 10) and felt that patients unresponsive to typical therapies should be evaluated for DB (n = 12). Consensus about the most effective currently available OTC treatment was not reached. CONCLUSIONS: The Delphi methodology proved effective in establishing consensus about DB, including signs, symptoms, and diagnosis. Consensus was not reached about the best treatment or how to grade severity. With increased awareness, eyecare practitioners can offer DB patients better clinical outcomes. A follow-up Delphi panel is planned to obtain further consensus surrounding DB treatment.

Delphi Panel Consensus Regarding Current Clinical Practice Management Options for Demodex blepharitis.

Purpose: To obtain consensus on Demodex blepharitis (DB) treatment using a modified Delphi panel process. Methods: Literature search identified gaps in knowledge surrounding treatment of DB. Twelve ocular surface disease experts comprised the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). They completed a live roundtable discussion in addition to 3 surveys consisting of scaled, open-ended, true/false, and multiple-choice questions pertaining to the treatment of DB. Consensus for scaled questions using a 1 to 9 Likert scale was predefined as median scores of 7-9 and 1-3. For other question types, consensus was achieved when 8 of 12 panelists agreed. Results: The experts agreed that an effective therapeutic agent for treatment of DB would likely decrease the necessity of mechanical intervention, such as lid scrubs or blepharoexfoliation (Median = 8.5; Range 2-9). When treating DB, panelists believed that collarettes serve as a surrogate for mites, and that eliminating or reducing collarettes should be the main clinical goal of treatment (Median = 8; Range 7-9). The panelists would treat patients with at least 10 collarettes, regardless of other signs or symptoms and agreed that DB can be cured, but there is always the possibility for a reinfestation (n = 12). There was also consensus that collarettes, and therefore mites, are the primary treatment target and the way by which clinicians can monitor patient response to therapy (Median = 8; Range 7-9). Conclusion: Expert panelists achieved consensus on key facets of DB treatment. Specifically, there was consensus that collarettes are pathognomonic for DB, that DB patients with >10 collarettes should be treated even in the absence of symptoms, and that treatment efficacy can be tracked by collarette resolution. By increasing awareness about DB, understanding the goals of and monitoring treatment efficacy, patients will receive better care and, ultimately, better clinical outcomes.

A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).

Purpose: We compare outcomes in eyes with dry eye disease (DED) treated with TearCare (TC) or topical cyclosporine 0.05% (RESTASIS; CsA). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, randomized, assessor-masked, controlled IRB-approved trial. Eligible subjects: ≥22 years of age, dry eye symptoms within 3-6 months, Tear Break-up Time (TBUT) ≥1 to ≤7 s, Meibomian Gland Secretion Score (MGSS) ≤12, Ocular Surface Disease Index (OSDI) of 23-79. Randomized (1:1) to TC or CsA. TC subjects treated at baseline and month 5; CsA was twice daily for 6 months. Methods: Follow-up visits were scheduled for Day 1, Week 1, Months 1, 3, and 6 with primary inference at Month 6. Primary outcomes: TBUT and OSDI; secondary outcomes: MGSS, conjunctival and corneal staining, eye dryness score (EDS), symptoms assessment in dry eye (SANDE) score, and Schirmer tear score (STS). Safety assessments included adverse events, best corrected visual acuity, intraocular pressure, and slit-lamp findings. Results: Overall, 345 subjects, 172 TC and 173 CsA. TBUT improved at all time points in both groups (p<0.0001), with statistically greater improvement for TC versus CsA (p=0.0006). OSDI improved significantly at all time points in both groups (p<0.0001) with no significant differences between treatments. MGSS and other measures of meibomian gland function improved significantly more with TC eyes versus CsA; other secondary outcomes showed significant improvements in both groups with no difference between groups. Treatment-related adverse events were uncommon (10 total, 8 in the CsA group consistent with prior CsA studies); most (9/10) mild. Conclusion: TC provides statistically superior and sustained improvement in TBUT and multiple measures of meibomian gland secretion, and non-inferior improvement in OSDI, corneal and conjunctival staining, SANDE, EDS, and STS versus CsA. TC should be a preferred treatment for DED associated with MGD.

Giant fornix syndrome: a case series.

PURPOSE: To describe the demographics, characteristics, and treatment of giant fornix syndrome, a rare cause of chronic purulent conjunctivitis in the elderly. METHODS: Retrospective chart review of five patients with giant fornix syndrome evaluated by the Cornea Service, Oculoplastics and Orbital Surgery Service and the Department of Pathology at the Wills Eye Institute. RESULTS: The median age of the 5 female patients was 75 years (mean 80, range 70-95). The median duration of eye symptoms before presentation was 2 years (mean 2.4, range 1-4). Before referral, the chronic conjunctivitis was treated with topical antibiotics in all 5 cases and with additional dacryocystorhinostomy in one case. The right eye was affected in 2 cases, and the left eye was affected in the other 3 cases. Floppy eyelids were present in 2 cases. The superior fornix was involved in 4 cases, and the inferior fornix was involved in one case. Pseudomembranes and superficial punctate keratitis (SPK) were seen in 3 cases. Diagnosis of giant fornix syndrome was made in all 5 cases. Conjunctival culture grew methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, and S. aureus in singular cases. Case 1 was treated with topical moxifloxacin, Case 2 was treated with topical vancomycin and repair of the upper eyelid, Case 3 was treated with topical besifloxacin, and Case 4 was treated with dacryocystorhinostomy and topical vancomycin. Case 5 was treated with reconstruction of the left upper eyelid. The median duration of follow up was 4 months (mean 21.6, range 1-84). CONCLUSIONS: Giant fornix syndrome can lead to chronic relapsing conjunctivitis in the elderly. Deep conjunctival fornices in affected patients can be a site for prolonged sequestration of bacteria causing recurrent infections. Removing the infected debris from the superior fornix and reconstruction of the upper eyelid may prevent the recurrent chronic persistent infection.

Economic Impact Analysis of Custom Pak® on Cataract and Vitreoretinal Surgery in the United States.

Purpose: Implicit costs of surgical preparation and materials management for cataract/anterior segment and retinal/posterior segment procedures are often unquantified. Use of ophthalmological surgical procedure packs is common in these surgeries; however, there is little in the literature demonstrating their time and cost impacts. Understanding the costs and potential benefits of surgical pack procedure use is important for administrators in purchasing decision-making. The objective of this study is to estimate the economic impact of Alcon Custom Pak® on cataract and vitreoretinal (retina) surgery in hospitals and ambulatory surgical centers (ASCs) across operating room (OR), materials management, and accounting departments. Methods: We conducted a study in 2019 among US hospitals and ASCs using an online survey and a surgery timing exercise. Surgical technicians and supply chain managers were surveyed regarding current cataract and retina surgery practices including OR, materials management, and accounting tasks. Surgical technicians timed cataract and retina surgeries, recording activity timestamps and surgical supply use from Alcon Custom Pak and other sources. Using the survey and timing exercise inputs and literature and government sources, we developed a budget impact model (BIM) to quantify hidden costs of time and labor spent across the entire surgery supply life cycle. Results: Representing a geographical mix of 99 facilities, surgical technicians (56 cataract/46 retina) and supply chain managers (23 cataract/24 retina) provided data for their institutions. Technicians timed 290 cataract and 250 retina surgeries. In the BIM, increasing baseline Custom Pak utilization to 100% of surgeries while also sourcing all relevant supplies from Custom Pak results in annual cost savings ranging from $92,273 to $217,675 across procedure type and setting, allowing for between 75 (retina ASC) and 266 (cataract hospital) potential additional procedures per facility/year. Conclusion: This study demonstrates that increasing Custom Pak usage can potentially save time, reduce hidden costs, and increase throughput.

Development of a Nomogram to Predict Graft Survival After Penetrating Keratoplasty.

PURPOSE: To develop a nomogram to predict the 3- and 5-year likelihood of graft survival after penetrating keratoplasty (PK) based on preoperative assessment and intraoperative plan. DESIGN: Retrospective clinical case-control study. METHODS: Data from 1,029 consecutive PKs in 903 eyes of 835 patients performed at a single tertiary center from May 2007 to September 2018 were extracted from electronic medical records and evaluated for corneal graft failure, defined as irreversible and visually significant graft edema, haze, or scarring. Thirty-seven variables were assessed by multivariable Cox models. A nomogram to predict the probability of graft survival was created. RESULTS: Mean recipient age was 57.1 ± 22.0 years and mean follow-up was 4.22 ± 3.05 years. Overall, 37.4% of grafts failed during follow-up. Eleven variables were significantly associated with graft failure, including active microbial infection at the time of PK (hazard ratio [HR] = 5.10, 95% confidence interval [CI] 3.53-7.37), intraocular silicone oil at the conclusion of the PK (HR = 4.28, 95% CI 2.38-7.71), history of systemic autoimmune disease (HR = 2.83, 95% CI 1.63-4.90), 4 quadrants of corneal neovascularization (HR = 2.76, 95% CI 1.56-4.86), any prior anterior segment surgery (HR = 2.41, 95% CI 1.55-3.75), and lens status as anterior chamber intraocular lens at the conclusion of surgery (HR = 2.35, 95% CI 1.30-4.26). The nomogram exhibited a concordance index of 0.76 (95% CI 0.74-0.78); internal calibration plots depicted strong correlation between prediction and observation of graft survival. CONCLUSIONS: PK graft prognosis may be predicted relatively accurately based on 11 variables. Although established from retrospective data, this nomogram would be valuable for data-driven patient counseling prior to corneal transplantation.

Posterior lamellar keratoplasty: techniques, outcomes, and recent advances.

Over the past 2 decades, posterior lamellar keratoplasty (PLK) has emerged as an alternative to penetrating keratoplasty in the treatment of corneal endothelial disorders. The reasons for this trend include the search for a safer procedure to replace diseased endothelium that provides faster and better visual rehabilitation and reduces the need for postoperative care. Different surgical techniques, surgical instruments, devices, and lasers have been introduced to overcome technical difficulties, thus improving clinical outcomes. Yet, surgeons and eye banks must address the complications and limitations that arise during the transition to these new techniques. This review discusses the most significant aspects of the evolution of PLK, including a detailed description of current techniques and the direction of future treatment for corneal endothelial disease with the use of laser-assisted surgery, bioengineered corneas, cell therapy, and new pharmacologic therapy.

Actinic Granuloma of the Conjunctiva: Case Series and Review of the Literature.

PURPOSE: To characterize the clinical and histopathologic features of actinic granuloma of the conjunctiva. DESIGN: Retrospective observational case series METHODS: Institutional pathology records between 2014 and 2020 were searched for all cases of conjunctival actinic granuloma. Information collected included age, sex, ocular and medical history, clinical findings, laboratory workup, treatment, follow-up, pathologic diagnosis, and histopathologic inflammation pattern. RESULTS: Eight eyes of 8 patients, 5 men and 3 women, with a median age of 43 years (mean 49, range 24-83) were identified. Clinical diagnosis was pterygium (n = 4, 50%), inflamed pterygium (n = 1, 13%), pterygium vs conjunctival squamous cell carcinoma (n = 1, 13%), episcleritis vs inflamed pinguecula (n = 1, 13%), and scleritis vs keratoacanthoma (n = 1, 13%). Of 5 lesions with follow-up information, none recurred following excision with a median follow-up of 9 weeks (mean 19 weeks, range 1-61 weeks). Allergy/atopy was documented in 4 of 7 (57%) patients with available medical information. There were no other systemic associations. Histopathologically, actinic granuloma was associated with pterygium (n = 6, 75%) and pinguecula (n = 2, 25%). All lesions were composed predominantly of histiocytes and a variable number of foreign body-type giant cells associated with a focus of severe actinic elastosis. The inflammatory pattern was giant cell (n = 4, 50%), sarcoidal (n = 2, 25%), histiocytic (n = 1, 13%), and combined histiocytic and sarcoidal (n = 1, 13%). CONCLUSION: Conjunctival actinic granuloma has diverse clinical and histopathologic manifestations, which need to be distinguished from other autoimmune, neoplastic, and infectious etiologies. This lesion frequently occurs in pre-existing pterygium and pinguecula and may be associated with allergy and atopy.

Surgical outcomes in cases of contact lens-related Fusarium keratitis.

OBJECTIVES: To examine seven cases of contact lens-related Fusarium keratitis that resulted in therapeutic penetrating keratoplasty, to investigate which factors were associated with favorable versus poor graft outcome in this population. METHODS: Seven patients who underwent corneal transplant after contact lens-related, culture-proven Fusarium keratitis were identified through a retrospective chart review. The cases occurred between September 2005 and January 2006 at the University of Medicine and Dentistry of New Jersey and Wills Eye Hospital. All seven patients had used Bausch and Lomb's ReNu with MoistureLoc. The outcomes studied were graft status, infection recurrence, and 6-month postoperative visual acuity. RESULTS: The rejection rate was 57.1% and the recurrence rate was 28.6% in this study. No eyes were lost to fungal endophthalmitis. In this population, larger ulcer size and a greater total number of medical agents used before and after penetrating keratoplasty were significantly associated with poor outcomes, namely graft rejection and poor visual acuity. In addition, it was noted that the patients who suffered recurrence of infection had both a larger median graft size and a longer median duration of postoperative antifungal use although these results did not reach statistical significance. CONCLUSIONS: Larger ulcer size, larger graft size, a greater number of medical agents used, and a longer duration of postoperative antifungal therapy may be useful parameters in predicting surgical outcomes in patients with fungal keratitis. Further research is needed to validate our results and to elucidate the mechanisms behind graft rejection in the setting of fungal keratitis.