scholarly journals Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial

2020 ◽  
Vol 64 (3) ◽  
pp. 398-404
Author(s):  
Jia Li ◽  
Xu Bai ◽  
Xiaoyue Guan ◽  
Hongfeng Yuan ◽  
Xiang Xu

<b><i>Purpose:</i></b> This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). <b><i>Methods:</i></b> This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. <b><i>Results:</i></b> All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (<i>p</i> &#x3e; 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (<i>p</i> &#x3c; 0.05); however, there were no statistically significant differences between the groups (<i>p</i> &#x3e; 0.05). In addition, no adverse events related to local transplantation were observed in the patients. <b><i>Conclusions:</i></b> A single, local MSC transplantation in the optic nerve is safe for patients with TON.

2020 ◽  
pp. 112067212092830
Author(s):  
Maurizio Battaglia Parodi ◽  
Maria Vittoria Cicinelli ◽  
Alessandro Marchese ◽  
Chiara Giuffrè ◽  
Francesco Viola ◽  
...  

Purpose To investigate the effect and the safety of intravitreal aflibercept in patients affected by choroidal neovascularization secondary to angioid streaks with a long-term follow-up. Methods Multicentre, open-label, phase IIb study (EYLEA-STRIE, EudraCT Number 2014-000986-30) involving four Italian centres (IRCCS Ospedale San Raffaele (Milano), Fondazione G.B. Bietti (Roma), Policlinico (Milano), Ospedale Luigi Sacco (Milano)). Patients with active choroidal neovascularization secondary to angioid streaks with foveal involvement were prospectively enrolled and followed for 18 months. All the patients received intravitreal 2 mg/0.05 mL aflibercept at the time of enrolment, followed by a pro-re-nata regimen for 48 weeks. Best-corrected visual acuity and central macular thickness were measured monthly. Adverse events were monitored at each visit. Results Twenty-three eyes of 20 patients were analysed. Mean number of injections per patient was 4.30 ± 1.2. At week 48, the best-corrected visual acuity was 0.42 ± 0.40 LogMAR (p = 0.6 from baseline) and 18 eyes (81.8%) featured stability within 15 letters. The central macular thickness significantly reduced (p = 0.03). Eleven ocular non-serious adverse events and two serious adverse events were observed (one case of endophthalmitis and one case of acute gastritis were reported). Conclusion Intravitreal aflibercept represents a valid option for the management of choroidal neovascularization complicating angioid streaks. Further studies with longer follow-up and different therapeutic regimens are warranted to ascertain the best control of the disease.


2021 ◽  
pp. 112067212110248
Author(s):  
Anna V Bux ◽  
Francesca Fortunato ◽  
Antonio Barone ◽  
Vincenzo Russo ◽  
Nicola Delle Noci ◽  
...  

Purpose: To assess the efficacy and safety of dexamethasone 0.7 mg implants (DEX-I) in patients with diabetic macular edema (DME) either naïve to therapy or refractory to anti-VEGF treatment, in a single-center, real-world setting. Methods: Patients diagnosed with DME and treated with DEX-I were retrospectively enrolled in the study and split in two groups: naïve (Group 1, n = 64) and refractory (Group 2, n = 64) to treatment. Patients were evaluated at baseline, at 1 month, and every 3 months after each DEX-I implant. Main outcome measures were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to follow-up visits. Results: Significant improvements in BCVA were observed in treatment-naïve patients at 6 months following the first and second DEX-I injection ( p = 0.0023 and p = 0.0063, respectively), with significant reductions in mean CMT at 6 months after all DEX implants. In treatment-refractory patients, mean CMT was significantly reduced from baseline to 6 months ( p < 0.05) after all DEX-I injections, although no changes were observed in BCVA. Conclusions: DEX-I improved visual acuity and macular edema mostly in treatment-naïve patients, suggesting DEX-I may be a viable first-line treatment option in DME.


2020 ◽  
pp. 112067212098320
Author(s):  
Ana Rita Carreira ◽  
João Cardoso ◽  
Diogo Lopes ◽  
Tomás Loureiro ◽  
Audrey Sampaio ◽  
...  

Purpose: To assess long-term vascular density measured by optical coherence tomography angiography (OCT-A) in former preterm children with history of retinopathy of prematurity (ROP) with and without need of laser treatment. Methods: This observational study included former preterm children that developed ROP stage 2 or 3. Infants were divided in two groups according to previous need of laser treatment, and underwent a complete ophthalmologic evaluation, including assessment of macular morphologic and vascular parameters by OCT-A. Results: Fifteen eyes were included in group 1 (laser-requiring ROP) and 19 in group 2 (non-treated ROP). Group 1 had lower mean gestational age and birth weight values than group 2 ( p < 0.001 and p < 0.001, respectively). Best corrected visual acuity (BCVA) was lower in group 1 (0.08 ± 0.04 logMAR vs 0.04 ± 0.07 logMAR, p = 0.03). Laser-requiring ROP had lower vascular parameters, especially of central and internal vascular density (9.15 ± 2.75 vs 10.52 ± 0.86 mm−1, p = 0.05; 13.74 ± 1.00 vs 15.86 ± 0.64 mm−1, p = 0.05; respectively), and lower avascular zone circularity (0.58 ± 0.06 vs 0.76 ± 0.02, p < 0.001). Mean macular thickness was higher in group 1 (300.50 ± 10.50 vs 281.11 ± 2.50 μm, p = 0.05). Best corrected visual acuity (BCVA) was correlated with superficial vascular density ( p < 0.05). Conclusion: Laser-requiring ROP seems to result in a decrease of long-term BCVA, which is at least partially attributed to a decrease in superficial macular vascular density. However, prematurity degree was more pronounced in children that required treatment, which might have influenced our results.


2006 ◽  
Author(s):  
Ηλίας Γεωργαλάς

Angioid streaks are irregular crack like dehiscences in Bruch's membrane that invariably radiate outward from the peripapillary area in all directions9. They are associated with a wide variety of systemic diseases, such as pseudoxanthoma elasticum, Ehler-Danlos syndrome, Paget's disease and sickle-cell hemoglobinopathies9.The prognosis in patients with angioid streaks is guarded because visual impairment occurs in 70% to 86% due to the occurrence of macular choroidal neovascularization (CNV)9,15,51. The natural history of such lesions is poor, with most resulting in fovea involvement and central vision loss9,187. Laser photocoagulation treatment of CNV may be beneficial in selected cases169,171,189,191. However, the recurrence rate is higher than with CNV associated with other macular disorders168,170 and the final results reported in the literature as being rather disappointing9. Recently, limited macular translocation176,177, as well as photodynamic therapy with verteporfin (PDT)151,152,154,155,157,182 were searched as alternative treatment modalities for subfoveal CNV due to angioid streaks in small series of patients with controversial results.The purpose of this study is to evaluate the effectiveness of conventional PDT with verteporfin in a large series of patients with subfoveal or juxtafoveal CNV due to angioid streaks and to compare it to the effectiveness of early retreatment PDT (8 weeks following initial therapy) in patients who experienced disease progression.MATERIALS AND METHODSA prospective analysis of 36 eyes of 33 consecutive patients with subfoveal or juxtafoveal CNV secondary to angioid streaks that were treated with PDT from January 2001 through January 2005 and completed at least 18 months of the follow-up time, was conducted. The greatest linear dimension of the entire lesion had to be 6000 pm or less. Eyes with best corrected visual acuity of less than 20/400 were not treated. None of the eyes had been previously treated by conventional laser photocoagulation for the macular CNV.Prior to the treatment, each patient had undergone a complete ocular examination including contact lens fundus biomicroscopy, color or red-free fundus photography, and digital fluorescein angiography (FA) using the Topcon Imagenet 2000 Digital Imaging System with TRC-50IA fundus camera (Topcon Corporation, Paramus, New Jersey, USA). Fluorescein angiograms were evaluated for lesion size and leakage of the neovascular membrane. Best-corrected visual acuity was determined in all patients using standard Snellen charts.Patients were divided in 2 groups. In group 1, retreatments were performed according to the standard protocol followed in the Treatment of Age-Related Macular Degeneration with Photodynamic Therapy Investigation (TAP) every 12 weeks107, 146. During this time, 17 eyes of 15 patients were included in the study in Group 1. In Group 2, 19 eyes of 17 patients received early retreatments (8 weeks after the previous PDT) when indicated according to the criteria of the TAP study for conventional 3-month retreatment.The follow-up time of the patients ranged from 18 to 66 months (mean 37.6 months). The re-examinations followed the same procedure as the first examination. Informed consent for examination and treatment was obtained from each patient after a full explanation of the procedure.Numerical data in the text and the tables are presented as mean (±SD). Improvement or decline of visual acuity was defined as a change of at least two lines.


2021 ◽  
Vol 7 (2) ◽  
pp. 358-362
Author(s):  
Gurvinder Khosa ◽  
Karanijit Singh ◽  
Prempal Kaur ◽  
Rajesh Kumar ◽  
Upasna Ajmani

The purpose of this study was to compare the effect of Phacoemulsification and Manual small incision cataract surgery (MSICS) on the corneal endothelium and to assess its impact on visual acuity and induced astigmatism. In this prospective randomized study, 100 cases were randomly selected with the help of lottery system. 50 cases underwent phacoemulsification (group 1) and 50 underwent MSICS (group 2) by a single surgeon. The endothelial cell count, central corneal thickness, best corrected visual acuity and induced astigmatism was measured preoperatively and postoperatively on day 1, 7, 28 and on day 42. Mean endothelial cell loss (cells/mm2) in group 1 at the end of six weeks was 538.64 (20.59%) and in group 2 was 485.66 (19.20%) which was statistically insignificant (p &#62;0.05). The mean central corneal thickness was reduced in both the groups with a mean of 0.51±0.04 mm in group 1 and 0.50±0.03 mm in group 2 which was statistically insignificant. Postoperative best corrected visual acuity of more than 6/18 was found in 49 (98%) cases in each group at six weeks, and was statistically insignificant (p value &#62; 0.05). Phacoemulsification group had statistically significant less mean postoperative astigmatism than MSICS group (p value &#60; 0.05). Both groups gave similar statistically insignificant results in relation to endothelial cell loss, central corneal thickness and best corrected visual acuity at the end of six weeks, although the mean astigmatism was more in group 2 in comparison to group 1 with a statistically significant difference.


Author(s):  
Jay Chhablani ◽  
Gagan Kalra ◽  
Lubna Alkwatli ◽  
Bernd Fassbender ◽  
Francesca Amoroso ◽  
...  

Abstract Background Subthreshold microsecond pulsing laser is an increasingly common treatment approach for central serous chorioretinopathy. However, there is no literature available on the safety of microsecond laser using different fluence settings in this disease. While many publications can be obtained from conventional microsecond pulsing lasers, few parameter sets are published with the navigated microsecond pulsing laser. Therefore, this study aims to investigate the safety of different parameter sets in subthreshold microsecond pulsing laser treatments. Methods In this retrospective chart review, consecutive patients with central serous chorioretinopathy (> 3 months duration of symptoms) treated with navigated subthreshold microsecond pulsing laser and a follow up of at least five months after microsecond laser application were included. For each patient, the treatment parameters, plan layout, and adverse events related to laser were evaluated. Secondary outcomes included best-corrected visual acuity and anatomical improvements (central retinal thickness). Results One hundred and one eyes were included in the observation and followed for a mean of 10 months (range 5–36). Although a larger range of parameter sets and fluence settings have been used, no patient demonstrated adverse events from navigated microsecond pulsing laser. While 88% of the cases demonstrated stability, 13 cases lost five or more letters due to the persistence of the subretinal fluid. In mean, a best-corrected visual acuity improvement of 0.07logMar (± 0.2) was seen (p = 0.02). In 51% of the patients, a statistically significant improvement of the central retinal thickness was noted at the last follow-up with a mean thickness reduction of 70 µm (± 143) (p < 0.01). Conclusion In conclusion, none of the used parameter sets lead to tissue damage (when using a cautious titration) and, in summary, lead to an improvement in subretinal fluid and improvement in visual acuity. However, further prospective studies are needed to correctly identify the dependency of the treatment strategy on the outcome criteria.


2013 ◽  
Vol 13 (2) ◽  
pp. 33-41
Author(s):  
Devendra Maheshwari ◽  
Rengappa Ramakrishanan ◽  
Mohideen Abdul Kader ◽  
Neelam Pawar ◽  
Ankit Gupta

Aim: To evaluate the effect of phacoemulsification with intraocular lens implantation in eyes with pre-existing trabeculectomy.Methods: This prospective single-center clinical study evaluated intraocular pressure in 60 eyes of 60 patients who underwent phacoemulsification and implantation of a foldable intraocular lens after a previous successful trabeculectomy. Patients who had a trabeculectomy more than one year prior to the study were included. Intraocular pressure, number of antiglaucoma medications, bleb appearance, and visual acuity were recorded preoperatively, and at each follow-up examination and 12 months after phacoemulsification.Results: The mean intraocular pressure before phacoemulsification was 12.42 mmHg (SD, 4.60 mmHg), which increased to 14.98 mmHg (SD, 4.18 mmHg), 14.47 mmHg (SD, 3.58 mmHg), 15.44 mmHg (SD, 3.60 mmHg), and 15.71 mmHg (SD, 3.47 mmHg) after one, three, six, and 12 months, respectively. At each follow-up visit, the mean IOP was significantly higher than the preoperative value (p < 0.001, p = 0.015, p ≤ 0.001, and p = 0.001 at month one, three, six, and 12, respectively). The mean preoperative best-corrected visual acuity was 0.98 logMAR (SD, 0.44 logMAR) and the mean postoperative best-corrected visual acuity at 12 months was 0.20 logMAR (SD, 0.21 logMAR) [p = 0.0001]. The mean preoperative number of antiglaucoma medications used was 0.57 (SD, 0.63), which increased to 0.65 (SD, 0.63 ), 0.70 (SD, 0.72 ) 0.68, (SD, 0.70), and 0.67 (SD, 0.77 ) at one, three, six, and 12 months, respectively, but there were no statistically significant differences. Bleb size decreased clinically after phacoemulsification. Nineteen of 60 eyes (32%) developed fibrosis of bleb with decreased bleb size.Conclusion: Phacoemulsification with intraocular lens implantation significantly increased intraocular pressure and increased the number of antiglaucoma medications in eyes with pre-existing functioning filtering blebs.


2021 ◽  
Vol 13 ◽  
pp. 251584142110408
Author(s):  
Burçin Çakır ◽  
Nilgün Özkan Aksoy ◽  
Sedat Özmen ◽  
Özlem Bursalı

Background: Amblyopia is more common in children with high astigmatism, but factors contributing to development of amblyopia and visual outcomes are not fully understood. Objective: To evaluate the effect of amblyopia on the clinical outcomes in children with ⩾1.75 diopter (D) astigmatism. Methods: We reviewed the medical records of children with ⩾1.75 D astigmatism with and without amblyopia (amblyopes group and non-amblyopes group). The mean age, gender, amount and type of ocular deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best-corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were assessed and compared between the groups. Best-corrected visual acuity (BCVA), mean SE, astigmatism measurements were assessed and compared between amblyopic, fellow, and non-amblyopic eyes. Results: The records included 68 eyes of 34 children with amblyopia and 56 eyes of 28 children without amblyopia. The mean age, gender, amount and type of ocular deviation, presence of CI, stereopsis, time of initial spectacle use, follow-up time, and the difference in SE did not differ between groups. In amblyopes, exodeviation was more common and statistically greater in near (33 cm) than at distance (6 m) (p = 0.005). The mean BCVA and astigmatism values were statistically different between amblyopic, fellow, and non-amblyopic eyes. Conclusion: A greater near than distance exodeviation and higher mean astigmatism value were found in amblyopic children with astigmatism.


2021 ◽  
Vol 14 (3) ◽  
pp. 416-422
Author(s):  
Yong Cheng ◽  
◽  
Ming-Wei Zhao ◽  
Tong Qian ◽  
◽  
...  

AIM: To evaluate the two-year outcomes of patients treated for diabetic macular edema (DME) with intravitreal Conbercept (IVC). METHODS: The clinical data of 30 DME patients (36 eyes) were retrospectively reviewed. The patients were treated with IVC for 3mo. Additional IVC was given at subsequent monthly visits, if needed (3+PRN). The patients were followed up for 24mo. RESULTS: The best-corrected visual acuity (BCVA) at 24mo significantly increased (66.7±15.3 letters) in comparison with the baseline (54.4±15.4 letters, P<0.0001). The mean improvement in BCVA was 11.0±2.9 letters. At 24mo, 44.1% of the eyes surveyed gained ≥15 letters, 52.9% of the eyes gained ≥10 letters, and 70.6% of the eyes gained ≥5 letters. No vision loss was noted in 96.8% of the eyes, and 5.9% of the eyes lost ≥5 letters, but ≤10 letters. The central retinal thickness (CRT) at 24mo was significantly reduced (277.1±122.9 μm) in comparison with the baseline (510.9±186.1 μm, P<0.0001). At 24mo, 43.3% of the patients had a CRT ≤250 μm. The mean number of injections over 24mo was 10.6±2.0. No severe eye or systemic adverse events related to either the drug or injection were noted. CONCLUSION: IVC is safe and effective for the treatment of DME.


2016 ◽  
Vol 9 (3) ◽  
Author(s):  
Mumtaz Hussain ◽  
Muhammad Moin ◽  
Nazir Ahmad Aasi ◽  
Muhammad Waqas ◽  
Jawaid Mughal

The study of 30 patients was performed at Lahore General Hospital, and Institute Of Ophthalmology Mayo Hospital, Lahore from June 1989 to June 2003 for 14 years. Total number of eyes were 34 where 2 patients had both eyes. Age ranged from 12-65 years. Males were 11 and females were 19. all the patients had planned extracapsular cataract extraction with IOL implantation. Total follow up period ranged from 1-5 years and best corrected visual acuity in these patients after surgery was 6/12 to 6/6. Post operatively, eyes had vitreous membranes and glaucomatous reaction.


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