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Interim Analysis of Clinical Outcomes with Open versus Closed Conjunctival Implantation of the XEN45 Gel Stent

McGlumphy, Elyse J; Do, Anna; Du, Amy; Craven, Earl Randy; Geyman, Lawrence S; Shen, Leo; Schuman, Joel S; Panarelli, Joseph F
OBJECTIVE:To examine the longitudinal postoperative outcomes of open versus closed conjunctiva implantation of the XEN45 gel stent. DESIGN/METHODS:Retrospective multicenter study. SUBJECTS/METHODS:One hundred ninety-three patients with glaucoma underwent XEN45 implantation via an open or closed conjunctiva approach. METHODS:Data on patient demographics; diagnoses; preoperative and postoperative clinical data; outcome measures, including intraocular pressure (IOP); use of glaucoma medications; visual acuity; and complications were collected. Statistical analyses were performed with P < 0.05 as significant. MAIN OUTCOME MEASURES/METHODS:Failure was defined as < 20% reduction in IOP from the medicated baseline or a IOP of > 21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event, such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Overall success was defined as those who achieved success either with or without topical medications. RESULTS:Patients were followed for an average of 17 months. Complete success was achieved in 42.5% and 24.7% of the open and closed groups, respectively (P = 0.01). Overall success was achieved in 64.2% and 37.0% of the open and closed groups, respectively (P < 0.001) at the last follow-up. Bleb needling was performed in 12.4% of eyes in the open group compared with 40% of eyes in the closed group. An IOP spike of ≥ 10 mmHg was twice as likely to occur in the closed group compared with the open group during the postoperative period (40% vs. 18%; P = 0.001). CONCLUSIONS:Implantation of XEN45 with opening of the conjunctiva resulted in a lower IOP with greater success and lower needling rate compared with those achieved with the closed conjunctiva technique. Similar rates of postoperative complications and vision loss were noted in each group. Although both procedures provide substantial IOP reduction, the open technique appears to result in higher success rates and fewer postoperative interventions. FINANCIAL DISCLOSURE(S)/BACKGROUND:Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
PMID: 37709048
ISSN: 2589-4196
CID: 5593442

Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study

Panarelli, Joseph F; Bowden, Eileen C; Tepedino, Michael E; Odani-Kawabata, Noriko; Pei, Zifan; McLaurin, Eugene B; Ropo, Auli
PRCIS/CONCLUSIONS:This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost. PURPOSE/OBJECTIVE:The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/nonresponders with POAG or OHT. MATERIALS AND METHODS/METHODS:Phase 3, nonrandomized, 2-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged 18 years or above, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye, and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. The primary study endpoint was changed from baseline in the mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events, serious adverse events, and adverse drug reactions. RESULTS:At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). The mean (SD) baseline MD IOP was 23.34 mm Hg (2.12). The mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) ( P <0.0001). No significant safety issues were reported during OMDI treatment. CONCLUSIONS:These data demonstrate OMDI efficacy and safety in latanoprost low/nonresponders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study.
PMCID:10681282
PMID: 37853676
ISSN: 1536-481x
CID: 5628112

Neuro-Ophthalmologic Variability in Presentation of Genetically Confirmed Wolfram Syndrome: A Case Series and Review [Case Report]

Jauregui, Ruben; Abreu, Nicolas J; Golan, Shani; Panarelli, Joseph F; Sigireddi, Meenakshi; Nayak, Gopi K; Gold, Doria M; Rucker, Janet C; Galetta, Steven L; Grossman, Scott N
Wolfram syndrome is a neurodegenerative disorder caused by pathogenic variants in the genes WFS1 or CISD2. Clinically, the classic phenotype is composed of optic atrophy, diabetes mellitus type 1, diabetes insipidus, and deafness. Wolfram syndrome, however, is phenotypically heterogenous with variable clinical manifestations and age of onset. We describe four cases of genetically confirmed Wolfram syndrome with variable presentations, including acute-on-chronic vision loss, dyschromatopsia, and tonic pupils. All patients had optic atrophy, only three had diabetes, and none exhibited the classic Wolfram phenotype. MRI revealed a varying degree of the classical features associated with the syndrome, including optic nerve, cerebellar, and brainstem atrophy. The cohort's genotype and presentation supported the reported phenotype-genotype correlations for Wolfram, where missense variants lead to milder, later-onset presentation of the Wolfram syndrome spectrum. When early onset optic atrophy and/or diabetes mellitus are present in a patient, a diagnosis of Wolfram syndrome should be considered, as early diagnosis is crucial for the appropriate referrals and management of the associated conditions. Nevertheless, the condition should also be considered in otherwise unexplained, later-onset optic atrophy, given the phenotypic spectrum.
PMCID:10376978
PMID: 37508961
ISSN: 2076-3425
CID: 5593192

Risk factors and management of choroidal effusions

Ying, Stephanie; Sidoti, Paul A; Panarelli, Joseph F
PURPOSE OF REVIEW/OBJECTIVE:Choroidal effusions are recognized as a common early postoperative complication of glaucoma surgery, and although often benign, they may cause significant ocular morbidity. This article aims to summarize current research on the risk factors and management of choroidal effusions. RECENT FINDINGS/RESULTS:Glaucoma drainage device (GDD) implantation and trabeculectomy are the most commonly performed surgeries for the management of moderate to severe glaucoma. Common postoperative complications of these procedures include hypotony and the development of choroidal effusions. Choroidal effusions have recently been associated with the oral administration of certain drugs, including select monoclonal antibody, antiseizure and bisphosphonate medications. Risk factors for effusion development include specific patient characteristics such as pseudoexfoliative glaucoma, older age and hypertension. Although choroidal effusions typically resolve with medical therapy alone, surgical intervention may be required. Various methods of surgical intervention, such as surgical drainage or GDD tube ligation, can be utilized to treat choroidal effusions when conservative management with medical treatment fails, but themselves carry alternative risks that must be considered. SUMMARY/CONCLUSIONS:Minimizing the incidence and duration of hypotony following ophthalmic surgery and careful monitoring of patients starting certain oral medications are important in limiting the occurrence of choroidal effusions. Risk factors for choroidal effusions have been recently identified in the literature. A better understanding of these risk factors, as well as the outcomes of choroidal effusion management, can help to reduce the occurrence of effusions overall and minimize ocular morbidity.
PMID: 36730733
ISSN: 1531-7021
CID: 5420422

Extreme intraocular pressure and steroid-dependent iritis

Samuelson, Thomas W; Huang, Marshall J; Larsen, Christine L; Sheybani, Arsham; Levin, Ariana; Ertel, Monica; Pantcheva, Mina; Panarelli, Joseph F; Do, Anna
A 50-year-old ophthalmic technician was referred by her retina specialist for urgent consultation due to markedly elevated intraocular pressure (IOP) unresponsive to medical therapy. Her history included chronic polyarticular juvenile rheumatoid arthritis and chronic uveitis requiring ongoing topical steroid therapy. She had a sub-Tenon injection of Kenalog (triamcinolone) 18 months prior to referral. Chronic topical anti-inflammatory therapy included nepafenac (Ilevro) and prednisolone acetate 2 times a day. Attempts to discontinue topical steroid resulted in worsening inflammation. The patient was referred when the IOP measured 44 mm Hg in the left eye despite aggressive medical therapy, including acetazolamide. The IOP improved slightly when loteprednol was substituted for prednisolone acetate. Current medications in the left eye include brimonidine 3 times a day, loteprednol 2 times a day, nepafenac 2 times a day, and fixed combination latanoprost + netarsudil at bedtime. Her only medication in the right eye was travoprost. She is intolerant to dorzolamide. She was also taking acetazolamide 500 mg 2 times a day. She was not taking any anticoagulants. Past surgical history included cataract surgery in each eye. She has not had laser trabeculoplasty in either eye. Examination revealed uncorrected visual acuity of J1+ in the right eye (near) and 20/30 in the left eye (mini-monovision). There was no afferent pupillary defect. There was mild band keratopathy in each eye while the central cornea was clear in both eyes without keratic precipitates. Here angles were open to gonioscopy without peripheral anterior synechia. There was mild to moderate flare in each eye with trace cells. The IOP was 17 mm Hg in the right eye and 31 mm Hg in the left. Central corneal thickness measured 560 μm and 559 μm in the right and left eye respectively. There was a well-positioned intraocular lens within each capsule with a patent posterior capsulotomy. There was mild vitreous syneresis but no vitreous cell. The cup to disc ratio was 0.5 in each eye with a symmetrical neural rim. The retina was flat without macular edema. Visual field was normal in both eyes (Figures 1 and 2). Optical coherence tomography of retinal nerve fiber layer (RNFL) is shown in Figure 3 and retinal ganglion cell layer is shown in Supplemental Figure 1 (http://links.lww.com/JRS/A756).JOURNAL/jcrs/04.03/02158034-202301000-00020/figure1/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure2/v/2022-12-26T045736Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202301000-00020/figure3/v/2022-12-26T045736Z/r/image-tiff Please comment on your management of this patient's left eye.
PMID: 36573765
ISSN: 1873-4502
CID: 5471002

Automated 360-degree goniophotography with the NIDEK Gonioscope GS-1 for glaucoma

Madu, Chisom T; Phelps, Taylor; Schuman, Joel S; Zambrano, Ronald; Lee, Ting-Fang; Panarelli, Joseph; Al-Aswad, Lama; Wollstein, Gadi
This study was registered with ClinicalTrials.gov (ID: NCT03715231). A total of 20 participants (37 eyes) who were 18 or older and had glaucoma or were glaucoma suspects were enrolled from the NYU Langone Eye Center and Bellevue Hospital. During their usual ophthalmology visit, they were consented for the study and underwent 360-degree goniophotography using the NIDEK Gonioscope GS-1. Afterwards, the three ophthalmologists separately examined the images obtained and determined the status of the iridocorneal angle in four quadrants using the Shaffer grading system. Physicians were masked to patient names and diagnoses. Inter-observer reproducibility was determined using Fleiss' kappa statistics. The interobserver reliability using Fleiss' statistics was shown to be significant between three glaucoma specialists with fair overall agreement (Fleiss' kappa: 0.266, p < .0001) in the interpretation of 360-degree goniophotos. Automated 360-degree goniophotography using the NIDEK Gonioscope GS-1 have quality such that they are interpreted similarly by independent expert observers. This indicates that angle investigation may be performed using this automated device and that interpretation by expert observers is likely to be similar. Images produced from automated 360-degree goniophotography using the NIDEK Gonioscope GS-1 are similarly interpreted amongst glaucoma specialists, thus supporting use of this technique to document and assess the anterior chamber angle in patients with, or suspected of, glaucoma and iridocorneal angle abnormalities.
PMCID:9990915
PMID: 36881575
ISSN: 1932-6203
CID: 5432702

Choroidal Effusions after Glaucoma Drainage Implant Surgery: Risk Factors and Surgical Management

Ying, Stephanie; Coulon, Sara J; Lidder, Alcina K; Labowsky, Mary; Cheng, Christopher P; Vinod, Kateki; Sidoti, Paul A; Panarelli, Joseph F
OBJECTIVE:To report the incidence of patients who developed choroidal effusions after glaucoma drainage implant (GDI) surgery and determine risk factors for and outcomes of surgical intervention. DESIGN/METHODS:Retrospective case series. SUBJECTS/METHODS:Medical records of 605 patients who underwent GDI surgery from January 1, 2017 to June 7, 2021 at New York University Langone Health and New York Eye and Ear Infirmary of Mount Sinai were reviewed. METHODS:Preoperative, intraoperative, and postoperative clinical data were obtained. Multivariate logistic regression evaluated the factors associated with the need for surgical intervention. Patient records were analyzed for effusion resolution, intraocular pressure (IOP), visual acuity (VA), and complications across treatment modalities. MAIN OUTCOME MEASURES/METHODS:Incidence of choroidal effusion development and need for surgical intervention. RESULTS:Baerveldt glaucoma implant placement (P = 0.05; OR, 4.8), and anterior chamber shallowing (AC; P < 0.001; OR, 25.1) in the presence of effusions. The subgroup that required multiple surgeries for effusion resolution had a significantly lower mean IOP at the most recent follow-up compared with those who received medical management only (P < 0.001). A higher percentage of patients who required surgical intervention lost VA at the most recent follow-up compared with patients whose effusions resolved with conservative management (i.e., medical management, AC viscoelastic injection). CONCLUSIONS:Choroidal effusions after GDI surgery resolved with conservative management in most patients. A history of SLT or GDI placement, implantation of a BGI-350, and the presence of a shallow chamber were risk factors for surgical intervention. Although interventions, such as surgical drainage are at times necessary, a better understanding of their impacts can help guide postoperative decisions. The risks and benefits of these procedures must be carefully considered in these high-risk eyes. FINANCIAL DISCLOSURE(S)/BACKGROUND:Proprietary or commercial disclosure may be found after the references.
PMID: 36925067
ISSN: 2589-4196
CID: 5462592

Advanced Congenital Glaucoma with Corneal Staphyloma

Francis, Jasmine H; Folberg, Robert; Abramson, David H; Panarelli, Joseph F
PMID: 35788339
ISSN: 2589-4196
CID: 5280212

Bleb Management Following Trabeculectomy and Glaucoma Drainage Device Implantation

Panarelli, J F; Do, A T
While treatment options available to patients with glaucoma are expanding, trabeculectomy and glaucoma drainage device implantation (GDI) remain a mainstay in glaucoma surgical care. This article reviews key aspects of bleb management following trabeculectomy and GDI surgery. Basics of postoperative management of trabeculectomy and GDIs are reviewed, as well as how to manage complications such as early and late bleb leaks, fibrosis, bleb dysesthesia and the hypertensive phase. In general, careful surgical technique, close postoperative monitoring and appropriate intervention can help patients achieve safe outcomes and long-term control of intraocular pressure
Copyright
EMBASE:2022279103
ISSN: 1756-1752
CID: 5510222

Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study

Baker, N Douglas; Barnebey, Howard S; Moster, Marlene R; Stiles, Michael C; Vold, Steven D; Khatana, Anup K; Flowers, Brian E; Grover, Davinder S; Strouthidis, Nicholas G; Panarelli, Joseph F
PURPOSE:To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN:One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe. PARTICIPANTS:Eligible patients were aged 40-85 years with intraocular pressure (IOP) ≥15 and ≤40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy. METHODS:Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes). MAIN OUTCOME MEASURES:The primary effectiveness end point was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events. RESULTS:Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, -12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP ± standard deviation decreased from 21.1 ± 4.9 mmHg at baseline to 14.3 ± 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 ± 1.1 glaucoma medications (baseline 3.1 ± 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 ± 5.0 mmHg to 11.1 ± 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 ± 0.9 glaucoma medications (baseline 3.0 ± 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients. CONCLUSIONS:Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications.
PMID: 34051211
ISSN: 1549-4713
CID: 5108582