1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Retinal Occlusive Vasculitis after Intravitreal Injection of Brolucizumab
Jong Hoon LEE ; Tae Kyu MOON ; Yong-Sok JI
Journal of the Korean Ophthalmological Society 2024;65(2):161-166
Purpose:
To report two instances of retinal arterial occlusive vasculitis following intravitreal injection of brolucizumab.Case summary: Two patients noted decreased visual acuity approximately one month after receiving intravitreal brolucizumab injections to treat wet age-related macular degeneration. In case 1, an 85-year-old male reported a reduction in visual acuity in his left eye, declining from a Snellen measurement of 0.2 to hand motion. In case 2, a 70-year-old female experienced a decline in visual acuity in her right eye from 0.4 to finger count at 50 cm. Both patients presented with anterior chamber reactions, and fluorescein angiography demonstrated delayed retinal artery filling time, leading to the diagnosis of retinal occlusive vasculitis. They were treated with both topical and systemic corticosteroids. For case 1, a subsequent vitrectomy was performed to remove the inflammatory membrane located behind the intraocular lens. However, despite aggressive interventions, neither patient showed visual improvement.
Conclusions
Retinal occlusive vasculitis, which can result from intraocular inflammation, may occur after intravitreal brolucizumab injection. This condition can lead to significant visual impairment even with aggressive treatment.
3.The Efficacy and Safety of a Human Perirenal Adipose TissueDerived Stromal Vascular Fraction in an Interstitial Cystitis Rat Model
Ji Yong HA ; Eun Hye LEE ; So Young CHUN ; Jun Nyung LEE ; Yun-Sok HA ; Jae-Wook CHUNG ; Bo Hyun YOON ; Minji JEON ; Hyun Tae KIM ; Tae Gyun KWON ; Eun Sang YOO ; Bum Soo KIM
Tissue Engineering and Regenerative Medicine 2023;20(2):225-237
BACKGROUND:
Interstitial cystitis (IC) is a chronic and intractable disease that can severely deteriorate patients’ quality of life. Recently, stem cell therapy has been introduced as a promising alternative treatment for IC in animal models. We aimed to verify the efficacy and safety of the human perirenal adipose tissue-derived stromal vascular fraction (SVF) in an IC rat model.
METHODS:
From eight-week-old female rats, an IC rat model was established by subcutaneous injection of 200 lg of uroplakin3A. The SVF was injected into the bladder submucosal layer of IC rats, and pain scale analysis, awakening cytometry, and histological and gene analyses of the bladder were performed. For the in vivo safety analysis, genomic DNA purification and histological analysis were also performed to check tumorigenicity and thrombus formation.
RESULTS:
The mean pain scores in the SVF 20 ll group were significantly lower on days 7 and 14 than those in the control group, and bladder intercontraction intervals were significantly improved in the SVF groups in a dose-dependent manner. Regeneration of the bladder epithelium, basement membrane, and lamina propria was observed in the SVF group.In the SVF groups, however, bladder fibrosis and the expression of inflammatory markers were not significantly improved compared to those in the control group.
CONCLUSION
This study demonstrated that a perirenal adipose tissue-derived SVF is a promising alternative for the management of IC in terms of improving bladder pain and overactivity.
4.Clinical Manifestations and Prognostic Factors of Ocular Infection Associated with Orbital or Preseptal Cellulitis
Hyun Jee KIM ; Yong-Sok JI ; Kyung Chul YOON ; Hyeon-Jeong YOON
Journal of the Korean Ophthalmological Society 2023;64(10):871-878
Purpose:
We assessed the clinical manifestations and prognostic factors associated with ocular infection in patients diagnosed with orbital and preseptal cellulitis.
Methods:
We enrolled 40 patients diagnosed with ocular infection accompanied by orbital and preseptal cellulitis between October 2015 and December 2021. We divided patients into the “treatment success group” (patients whose infection resolved) and the “treatment failure group” (patients whose infection worsened and required evisceration). Clinical characteristics, such as infection-related ocular findings and microbiological features, were analyzed retrospectively in both groups. Chi-square tests and logistic regression analyses were performed to identify prognostic factors associated with treatment failure.
Results:
The mean age of patients was 72.8 ± 11.92 years, with 17 (42.5%) of them being male. Among the patients, 11 had bacterial infections, and 3 had fungal infections. In total, 6 (15%) and 34 (85%) patients were classified into the treatment success and failure groups, respectively. The chi-square test revealed a significant association between the treatment failure group and several clinical factors, such as low best corrected visual acuity (BCVA), the logarithm of the minimum angle resolution (logMAR) BCVA > 2, low intraocular pressure (IOP) < 5 mmHg, large size of the corneal lesion, and the presence of hypopyon (p < 0.05). Furthermore, the multivariate logistic regression analysis identified hypopyon as a significant risk factor for treatment failure (p = 0.036).
Conclusions
A significantly high treatment failure rate of 85% was observed in patients with ocular infections accompanied by orbital and preseptal cellulitis. Several clinical factors, such as low BCVA with logMAR BCVA > 2, IOP < 5 mmHg, large size of the corneal lesion, and a prolonged duration of symptoms demonstrated significant association with treatment failure. Notably, hypopyon is an important prognostic factor for treatment failure.
5.Accuracy of Intraocular Pressure Measurements of Eyes with Therapeutic Contact Lenses after Vitrectomy
Ja Young MOON ; Yung Hui KIM ; Yong-Sok JI
Journal of the Korean Ophthalmological Society 2022;63(5):426-433
Purpose:
To evaluate the accuracy of intraocular pressure (IOP) measurements obtained by a rebound and non-contact tonometer in eyes with a therapeutic contact lens (CL) after vitrectomy.
Methods:
In 60 eyes of 60 patients who underwent vitrectomy for vitreoretinal disease, IOP was measured using a rebound tonometer (iCare ic200®; IOPRT) and non-contact computerized air puff tonometer (CT-80, IOPNCT), before and after wearing a CL (Purevision2®, +0.0 diopter). The mean IOP of three consecutive measurements were analyzed, and a comparative analysis with IOP measured by a Goldman applanation tonometer (IOPGAT) was performed.
Results:
The mean IOPRT without and with the CL was 12.55 ± 5.43 and 13.12 ± 5.13 mmHg, respectively, showing a statistically significant difference (p = 0.02) and strong positive correlation (r = 0.90, p < 0.001). The mean IOPNCT with and without the CL was 12.18 ± 3.24 and 12.17 ± 3.14 mmHg, showing no statistically significant difference (p = 0.17). The consistency with IOPGAT (12.57 ± 5.22 mmHg) was highest in IOPRT without the CL, followed by IOPRT with the CL, IOPNCT without the CL, and IOPNCT with the CL (intraclass correlation coefficients = 0.955, 0.945, 0.856, and 0.850, respectively). In addition, the rebound tonometer successfully measured IOP, regardless of whether the CL was worn; however, the non-contact tonometer failed to measure IOP in seven eyes without the CL and nine with the CL. No difference was observed according to intraocular tamponade type.
Conclusions
A rebound tonometer can be used as an alternative IOL measuring method in eyes for which it is difficult to use a Goldman applanation tonometer due to the postoperative presence of a therapeutic CL.
6.Tear Neuromediators in Subjects with and without Dry Eye According to Ocular Sensitivity
Hyeon-Jeong YOON ; Won-Hee JANG ; Susun AN ; Yong Sok JI ; Kyung Chul YOON
Chonnam Medical Journal 2022;58(1):37-42
To investigate differences of tear neuromediators between subjects with and without dry eye (DE) depending on the ocular sensitivity. Thirty-one subjects with DE and 29 subjects without DE were recruited in this study. The eyes were stimulated by exposure to an irritating product applied to the periocular region. Both DE and non-DE subjects were divided into the high sensitivity and low sensitivity groups based on the degree of ocular sensitivity to ocular irritation. Baseline tear film break-up time (TBUT) and corneal staining score were examined, and tear samples were collected. The concentrations of the tear neuromediators, including nerve growth factor (NGF), serotonin, calcitonin gene-related peptide (CGRP), substance P, neuropeptide Y, and vasoactive intestinal peptide were measured using the enzyme-linked immune sorbent assay. The baseline neuromediator concentrations were compared between subjects with and without DE based on ocular sensitivity. In both DE and non-DE subjects, baseline TBUT was significantly lower in the high sensitivity group than in the low sensitivity group. In the high sensitivity group, baseline tear NGF levels were higher in subjects with DE than in those without DE. In the low sensitivity group, baseline levels of tear CGRP were lower in subjects with DE than in those without DE. Tear neuromediators associated with DE had differences in their concentrations depending on ocular sensitivity. In patients with DE, tear NGF levels increased with high ocular sensitivity to ocular irritation, whereas tear CGRP levels decreased with low ocular sensitivity.
7.Bilateral Corneal Edema After Inhalation of Spray Paint
Jonghwa KIM ; Yong Sok JI ; Kyung Chul YOON
Journal of the Korean Ophthalmological Society 2020;61(6):676-679
Purpose:
To report a case of acute bilateral corneal edema after inhalation of spray paint.Case summary: A 47-year-old male presented with blurred vision in both eyes 12 hours after inhalation of spray paint. He had no history of ocular surgery or chronic ocular disease. The corrected visual acuity was 20/100 in the right eye and 20/40 in the left eye. An ocular examination revealed diffuse bullous changes in the epithelium and mild stromal edema in the cornea of both eyes. At one week after treatment with topical hypertonic solutions and corticosteroids, the visual acuity had improved to 20/20 and slit-lamp examination showed clear corneas without edema.
Conclusions
Inhalation of a chemical substance can lead to acute bilateral corneal edema, even without direct contact, but the lesion may resolve rapidly.
8.Comparison of Clinical Characteristics in Vogt-Koyanagi-Harada Disease between Patients with and without Prodromal Manifestations
Hyun Ho JUNG ; Kyung Yun KOOK ; Yong Sok JI
Journal of the Korean Ophthalmological Society 2020;61(6):616-623
Purpose:
To compare the clinical characteristics of Vogt-Koyanagi-Harada (VKH) disease between patients with and without prodromal manifestations.
Methods:
We retrospectively reviewed the medical records of patients with VKH disease who were treated with systemic steroids. We grouped the patients into the incomplete type (36 eyes of 18 patients) and probable type (32 eyes of 16 patients) according to the presence of prodromal manifestations. We compared the following outcomes between groups: best-corrected visual acuity (BCVA), anterior chamber (A/C) cell, central foveal thickness (CFT), maximal subretinal fluid (SRF) height, choroidal thickness at baseline and 12 months after treatment, and recurrence rate.
Results:
BCVA logarithm of the minimum angle of resolution (logMAR) significantly improved from 0.37 ± 0.26 at baseline to 0.09 ± 0.17 at 12 months in the incomplete type group (p < 0.05) and from 0.35 ± 0.24 at baseline to 0.10 ± 0.18 at 12 months in the probable type group (p < 0.05); BCVA did not significantly differ between groups. Choroidal thickness significantly decreased at 12 months after treatment, compared with one week after treatment, in both groups (p < 0.05); choroidal thickness did not significantly differ between groups. There were no significant differences in clinical factors between groups, including baseline A/C cell, CFT, maximal SRF height, and recurrence rate.
Conclusions
No associations were found between disease type and clinical outcomes (BCVA, OCT findings, and recurrence). These data suggested that categorization of disease according to prodromal manifestations has limited usefulness in terms of clinical outcomes of VKH disease.
9.Short-term Clinical Outcomes of Scleral Fixation of Intraocular Lenses Using a Scleral Tunnel and Groove
Tae Kyu MOON ; Jae Yong JANG ; Hyun Ho JUNG ; Yong Sok JI
Journal of the Korean Ophthalmological Society 2019;60(3):246-252
PURPOSE: We evaluated the short-term clinical outcomes of patients who underwent modified scleral fixation of an intraocular lens (IOL) using a scleral tunnel and groove. METHODS: From June 2016 to May 2017, 34 eyes of 34 patients who underwent modified scleral fixation of an IOL using a scleral tunnel and groove were retrospectively studied. We evaluated the best-corrected visual acuity (BCVA), corneal endothelial cell density, intraocular pressure (IOP), spherical equivalent, and postoperative complications at 1 week, 1 month, 3 months, and 6 months after surgery. RESULTS: The BCVA was 0.85 ± 0.83 logarithm of the minimal angle of resolution (logMAR) before surgery and 0.38 ± 0.61 logMAR at 6 months (p = 0.001). The corneal endothelial cell count was 1,955.12 ± 217/mm2 and 1,852.59 ± 190/mm2, before and after surgery, respectively, which was not significantly different (p = 0.186). Postoperative complications occurred in eight eyes (23.5%); IOP elevation in one eye (2.9%), IOL tilt or decentration in two eyes (5.7%), optic capture in four eyes (11.4%), and cystic macular edema in one eye (2.9%). The spherical equivalent showed myopic changes after surgery and decreased significantly over time (p = 0.001). CONCLUSIONS: Modified scleral fixation of the IOL using a scleral tunnel and groove improved the BCVA, but did not significantly affect corneal endothelial cell loss. This procedure can be a good alternative to conventional scleral fixation of an IOL, which has advantages in shortened surgical time and easy surgical manipulation.
Corneal Endothelial Cell Loss
;
Endothelial Cells
;
Humans
;
Intraocular Pressure
;
Lenses, Intraocular
;
Macular Edema
;
Operative Time
;
Postoperative Complications
;
Retrospective Studies
;
Visual Acuity
10.Infectious Keratitis Caused by Shewanella Putrefaciens
Tae Kyu MOON ; Yong Sok JI ; Kyung Chul YOON
Journal of the Korean Ophthalmological Society 2019;60(8):787-791
PURPOSE: We report a case of infectious keratitis caused by Shewanella putrefaciens in a patient after fishing. CASE SUMMARY: A 75-year-old male with no underlying disease other than hypertension was admitted to our hospital because of decreased visual acuity and congestion in his left eye for 2 weeks. At the first ophthalmic examination, the best-corrected visual acuity (BCVA) of the left eye was counting fingers. Slit lamp examination showed stromal infiltrates with 2.0 × 2.0 mm corneal epithelial defects, endothelial inflammatory plaques and 1 mm height hypopyon with severe inflammation in the anterior chamber. Bacterial culture tests were performed by corneal scraping, which were positive for Shewanella putrefaciens, followed by treatment with moxifloxacin and ceftazidime topical antibiotics. After 2 months of treatment, the BCVA of the left eye improved to 0.4 and the corneal lesion clinically improved with residual mild stromal opacity. CONCLUSIONS: Shewanella putrefaciens should be considered as a causal pathogen of infectious keratitis in patients after fishing. We report a case of infectious keratitis caused by Shewanella putrefaciens, which has never previously been reported in the Republic of Korea.
Aged
;
Anterior Chamber
;
Anti-Bacterial Agents
;
Ceftazidime
;
Corneal Ulcer
;
Estrogens, Conjugated (USP)
;
Fingers
;
Humans
;
Hypertension
;
Inflammation
;
Keratitis
;
Male
;
Republic of Korea
;
Shewanella putrefaciens
;
Shewanella
;
Slit Lamp
;
Visual Acuity

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