Effect of age on clinical and radiographic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up

Object Lumbar arthroplasty is approved in the US for the treatment of degenerative disc disease at 1 level in skeletally mature patients. However, a bias toward older patients (> 45 years of age) who are otherwise indicated for the procedure may exist. In this study, the clinical outcomes of patients from the Charité Investigational Device Exemption (IDE) study were analyzed on the basis of patient age. Methods There were 276 patients enrolled in the IDE study of the Charité Artificial Disc who underwent 1-level arthroplasty at either L4–5 or L5–S1, including 71 nonrandomized and 205 randomized individuals. Patient data were analyzed based on age (18–45 years [217 patients, Group 1] compared with 46–60 years [59 patients, Group 2]). Statistical analyses were performed based on 2-year postoperative improvements in Oswestry Disability Index (ODI), 36-item Short Form Health Survey (SF-36), and visual analog scale (VAS) scores (clinical outcome), as well as range of motion (radiographic outcome), and adverse events. Results There was no significant difference between the groups with respect to level implanted, operative time, blood loss, changes in ODI and VAS scores or any of the 8 component scores of the SF-36, compared with baseline, at all time points throughout the 24-month follow-up period (p > 0.10). Patient satisfaction was equivalent at 24 months, with 87% satisfaction in Group 1 and 85% satisfaction in Group 2 (no statistical difference). In addition, no significant differences were identified with respect to adverse events including approach related, neurological, technique related, or reoperation. Conclusions Although patients > 45 years of age may have comorbidities or contraindications for arthroplasty for a number of reasons, particularly osteopenia, this analysis demonstrates that patients who are indicated for 1-level arthroplasty experience similar clinical outcome, satisfaction, or adverse events compared with their younger counterparts.

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Conservative Treatment Versus UltrasoundGuided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial

January 2018 - Pain Physician ◽

10.36076/ppj.2020/23/253 ◽

2020 ◽

Vol 3;23 (6;3) ◽

pp. 253-264

Author(s):

Gülcan Öztürk

Keyword(s):

Conservative Treatment ◽

Group Analysis ◽

Meralgia Paresthetica ◽

Sf 36 ◽

Significant Difference ◽

Vas Scores ◽

Group 3 ◽

Group 2 ◽

Group 1

Background: Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient. Objectives: The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy. Study Design: A prospective, randomized, sham-controlled study. Setting: Health Sciences University Training and Research Hospital in Turkey. Methods: Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) USguided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period. Results: A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05). Limitations: The limitation of the study was a short follow-up period. Conclusions: US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment. Key words: Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation

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A comparative study to assess the satisfaction with clinical outcome of the patients suffering from hemiplegic shoulder subluxation and undergoing rehabilitation with and without Bobath shoulder sling

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20205002 ◽

2020 ◽

Vol 7 (12) ◽

pp. 4823

Author(s):

Ushnish Mukherjee ◽

Sourav Kundu ◽

Rachit Gulati ◽

Pankaj Kumar Mandal

Keyword(s):

Clinical Outcome ◽

Common Factor ◽

Patients Satisfaction ◽

Significant Difference ◽

Group 2 ◽

Scale Data ◽

Clinical Global Impression Improvement ◽

Shoulder Sling ◽

Group 1

Background: Hemiplegic shoulder subluxation is one of the most common factor for post-stroke upper limb disability. There are various ways to assess its outcome during rehabilitation, but the assessment of patients’ satisfaction with the shoulder support is often missed. This study was done to compare those patients’ satisfaction with clinical outcome who were undergoing same rehabilitation programme for their hemiplegic shoulder subluxation with and without Bobath shoulder sling.Methods: This prospective controlled interventional study was conducted on 30 patients of both sexes within the age group of 45-65 years with hemiplegic (duration <6 weeks) gleno-humeral subluxation (GHS). Screening of GHS was done by palpation. They were randomly divided in two groups of same number (15 in each group) and put on rehabilitation protocol with group 1 receiving Bobath shoulder Sling as support for subluxed shoulder and group 2 continuing without it. Patients’ satisfaction on clinical outcome was measured with clinical global impression-improvement (CGI-I) scale. Data were collected at 6 weeks (first follow up-visit), 12 weeks (visit 2) and at the end of the study i.e. 24 weeks (visit 3).Results: Statistically significant difference (p=0.003) in mean score of CGI-I at visit 1 suggested significant improvement for group 1 but no statistically significant difference in improvement was noticed between the groups at visit 2 (p=1.000) and visit 3 (p=0.724).Conclusions: Use of support for hemiplegic shoulder is beneficial only during early days of rehabilitation, not on prolonged use.

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Effects of posterior tibial slope on the mid-term results of medial unicompartmental knee arthroplasty

Arthroplasty ◽

10.1186/s42836-021-00070-y ◽

2021 ◽

Vol 3 (1) ◽

Author(s):

Zhijie Chen ◽

Kaizhe Chen ◽

Yufei Yan ◽

Jianmin Feng ◽

Yi Wang ◽

...

Keyword(s):

Knee Flexion ◽

Tibial Slope ◽

Posterior Tibial ◽

Significant Difference ◽

Medial Unicompartmental Knee Arthroplasty ◽

Group 3 ◽

Group 2 ◽

Postoperative Knee ◽

Group 1

Abstract Objective To evaluate the effect of medial posterior tibial slope (PTS) on mid-term postoperative range of motion (ROM) and functional improvement of the knee after medial unicompartmental knee arthroplasty (UKA). Methods Medical records of 113 patients who had undergone 124 medial UKAs between April 2009 through April 2014 were reviewed retrospectively. The mean follow-up lasted 7.6 years (range, 6.2–11.2 years). Collected were demographic data, including gender, age, height, weight of the patients. Anteroposterior (AP) and lateral knee radiographs of the operated knees were available in all patients. The knee function was evaluated during office follow-up or hospital stay. Meanwhile, postoperative PTS, ROM, maximal knee flexion and Hospital for Special Surgery (HSS) knee score (pre−/postoperative) of the operated side were measured and assessed. According to the size of the PTS, patients were divided into 3 groups: group 1 (<4°), group 2 (4° ~ 7°) and group 3 (>7°). The association between PTS and the knee function was investigated. Results In our cohort, the average PTS was 2.7° ± 0.6° in group 1, 5.6° ± 0.9° in group 2 and 8.7° ± 1.2° in group 3. Pairwise comparisons showed significant differences among them (p < 0.01). The average maximal flexion range of postoperative knees in each group was 112.4° ± 5.6°, 116.4° ± 7.2°, and 117.5° ± 6.1°, respectively, with significant difference found between group 1 and group 2 (p < 0.05), and between group 1 and group 3 (p < 0.05). However, the gender, age, and body mass index (BMI) did not differ between three groups and there was no significant difference between groups in terms of pre−/postoperative HSS scores or postoperative knee ROM. Conclusion A mid-term follow-up showed that an appropriate PTS (4° ~ 7°) can help improve the postoperative flexion of knee. On the other hand, too small a PTS could lead to limited postoperative knee flexion. Therefore, the PTS less than 4° should be avoided during medial UKA.

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The Relationship between Serum Ferritin Levels and 5-Year All-Cause Mortality in Hemodialysis Patients

Blood Purification ◽

10.1159/000515639 ◽

2021 ◽

pp. 1-7

Author(s):

Emre Erdem ◽

Ahmet Karatas ◽

Tevfik Ecder

Keyword(s):

Serum Ferritin ◽

Hemodialysis Patients ◽

Rank Test ◽

Significant Difference ◽

All Cause Mortality ◽

Group 3 ◽

Group 2 ◽

The Relationship ◽

Group 1

Introduction: The effect of high serum ferritin levels on long-term mortality in hemodialysis patients is unknown. The relationship between serum ferritin levels and 5-year all-cause mortality in hemodialysis patients was investigated in this study. Methods: A total of 173 prevalent hemodialysis patients were included in this study. The patients were followed for up to 5 years and divided into 3 groups according to time-averaged serum ferritin levels (group 1: serum ferritin <800 ng/mL, group 2: serum ferritin 800–1,500 ng/mL, and group 3: serum ferritin >1,500 ng/mL). Along with the serum ferritin levels, other clinical and laboratory variables that may affect mortality were also included in the Cox proportional-hazards regression analysis. Results: Eighty-one (47%) patients died during the 5-year follow-up period. The median follow-up time was 38 (17.5–60) months. The 5-year survival rates of groups 1, 2, and 3 were 44, 64, and 27%, respectively. In group 3, the survival was lower than in groups 1 and 2 (log-rank test, p = 0.002). In group 1, the mortality was significantly lower than in group 3 (HR [95% CI]: 0.16 [0.05–0.49]; p = 0.001). In group 2, the mortality was also lower than in group 3 (HR [95% CI]: 0.32 [0.12–0.88]; p = 0.026). No significant difference in mortality between groups 1 and 2 was found (HR [95% CI]: 0.49 [0.23–1.04]; p = 0.063). Conclusion: Time-averaged serum ferritin levels >1,500 ng/mL in hemodialysis patients are associated with an increased 5-year all-cause mortality risk.

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Impact of percutaneous embolization versus subinguinal microsurgical ligation on semen parameters in primary varicocele patients: comparative study

Egyptian Journal of Radiology and Nuclear Medicine ◽

10.1186/s43055-020-00370-4 ◽

2020 ◽

Vol 51 (1) ◽

Author(s):

Haytham M. Nasser ◽

Ahmed Hussein ◽

Gad M. Behairy ◽

Mostafa Abdo

Keyword(s):

Sperm Count ◽

Semen Analysis ◽

Statistical Significance ◽

Semen Parameters ◽

Male Factor ◽

Percutaneous Embolization ◽

Significant Difference ◽

Group 2 ◽

Group 1

Abstract Background Varicocele is an abnormally dilated pampiniform plexus of the veins within the spermatic cord and is considered the most common correctable cause of male factor infertility. Many approaches are described for treatment either surgical (tradition inguinal, subinguinal, and laparoscopic) or non-surgical percutaneous embolization. During the period from August 2017 to December 2018, we prospectively analyzed the preoperative and post-operative alteration of semen parameters (at 3 and 9 months) of the data collected from 63 patients with clinically evident varicocele referred to our tertiary hospital. Patients were divided into two groups: group 1, thirty-three patients who underwent subinguinal microsurgical ligation, and group 2, thirty patients who underwent percutaneous embolization. Results Sixty-three patients enrolled in this study were divided in two groups: group 1, patients who underwent surgery, and group 2, patients who underwent embolization; the mean age is 24.6 ± 1.27 years in group 1 and 23.7 ± 2 years in group 2; there was no statistically significant difference between the two groups as regards BMI, diabetes, hypertension, and smoking. Bilaterality was present in 15.2% of group 1 patients and 10% in group 2 patients (P value 0.06). Most of the patients were classified as grades 2 and 3 with no statistical significance regarding severity of the disease. Preoperative semen parameters for patients including sperm count, motility, and abnormal forms showed no statistically significant difference between the two groups. Post-intervention semen analysis was done twice during follow-up after 3 months and 9 months from the date of intervention. After 3 months, the semen parameters were improved in both groups in spite of the higher sperm count in group 2 but with no statistical significance. After 9 months follow-up, semen analysis showed persistent increase in sperm mobility in group 1 patients in comparison to group 2 patients. Both groups had better improvement in count of normal form with no statistical significant change. Conclusion Improvement of semen parameters while treating primary varicocele by either subinguinal microsurgery approach or percutaneous embolization shows equivalent outcomes.

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Association of Visual Appearance on Outcomes After Hallux Valgus Surgery

Foot & Ankle International ◽

10.1177/10711007211019940 ◽

2021 ◽

pp. 107110072110199

Author(s):

Hakan Bahar ◽

Kadir Ilker Yildiz

Keyword(s):

Hallux Valgus ◽

Short Form ◽

Functional Improvement ◽

Level Of Evidence ◽

Visual Appearance ◽

Chevron Osteotomy ◽

Sf 36 ◽

Functional Scores ◽

Group 2 ◽

Group 1

Background: In this study, our aim was to determine the effect of cosmetic improvement on patient satisfaction and functional scores in hallux valgus (HV) surgery. Methods: Preoperative foot photographs of 105 patients who had undergone chevron osteotomy for HV between 2016 and 2018 were taken. The patients were divided into 2 groups. Twenty-four months after surgery, the preoperative foot photographs were shown to patients in group 1 (n = 52) but not to patients in group 2 (n = 53). The groups were then compared using the visual analog scale (VAS), the American Orthopaedic Foot & Ankle Society Hallux Metatarsophalangeal-Interphalangeal (AOFAS Hallux MTP-IP), and the 36-Item Short Form Health Survey (SF-36) scores. Both groups were evaluated radiologically with preoperative and postoperative hallux valgus angles and intermetatarsal angles. Results: There was no difference between the 2 groups in terms of radiologic parameters either pre- or postoperatively, or AOFAS Hallux MTP-IP scores postoperatively. However, for group 1, the VAS was lower (0.4±0.8 vs 1.8±1.6, P = .003) and both the SF-36 physical functioning (88.3±18.1 vs 79.1±23.2, P = .017) and SF-36 mental health scores were higher (78.8±19 vs 69.2±16.3, P = .022). Conclusion: Visualizing improvement in the cosmetic appearance of the foot appears associated with patients’ perception of subjective pain and functional improvement. We recommend that preoperative foot photographs be taken and recorded. Level of Evidence: Level III, case-control study.

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Chronic Achilles Tendinopathy

The American Journal of Sports Medicine ◽

10.1177/0363546507303558 ◽

2007 ◽

Vol 35 (10) ◽

pp. 1659-1667 ◽

Cited By ~ 65

Author(s):

Wolf Petersen ◽

Robert Welp ◽

Dieter Rosenbaum

Keyword(s):

Synergistic Effect ◽

Short Form ◽

Achilles Tendinopathy ◽

Eccentric Training ◽

Treatment Groups ◽

Alternative Treatment Option ◽

Sf 36 ◽

Significant Difference ◽

Chronic Achilles Tendinopathy

Background Previous studies have shown that eccentric training has a positive effect on chronic Achilles tendinopathy. A new strategy for the treatment of chronic Achilles tendinopathy is the AirHeel brace. Hypothesis AirHeel brace treatment improves the clinical outcome of patients with chronic Achilles tendinopathy. The combination of the AirHeel brace and an eccentric training program has a synergistic effect. Study Design Randomized controlled clinical trial; Level of evidence, 1. Methods One hundred patients were randomly assigned to 1 of 3 treatment groups: (1) eccentric training, (2) AirHeel brace, and (3) combination of eccentric training and AirHeel brace. Patients were evaluated at 6, 12, and 54 weeks after the beginning of the treatment protocol with ultrasonography, visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) ankle score, and Short Form-36 (SF-36). Results The VAS score for pain, AOFAS score, and SF-36 improved significantly in all 3 groups at all 3 follow-up examinations. At the 3 time points (6 weeks, 12 weeks, and 54 weeks) of follow-up, there was no significant difference between all 3 treatment groups. In all 3 groups, there was no significant difference in tendon thickness after treatment. Conclusions The AirHeel brace is as effective as eccentric training in the treatment of chronic Achilles tendinopathy. There is no synergistic effect when both treatment strategies are combined. Clinical Relevance The AirHeel brace is an alternative treatment option for chronic Achilles tendinopathy.

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COMPARATIVE EVALUATION OF RESTORATIVE TREATMENTS ON NON-CARIOUS CERVICAL LESIONS OF COMPOSITE AND GLASS IONOMER CEMENT

Journal of Medicine and Pharmacy ◽

10.34071/jmp.2020.4.5 ◽

2020 ◽

pp. 38-45

Author(s):

Duong Nguyen Thi Thuy ◽

Huong Nguyen Thi Kim

Keyword(s):

Glass Ionomer Cement ◽

Glass Ionomer ◽

Cervical Lesions ◽

Composite Restorations ◽

Significant Difference ◽

Composite Glass ◽

Group 2 ◽

Ionomer Cement ◽

Group 1

Background: Composite and Glass ionomer cement (GIC) are common restorative materials of non carious cervical lesions (NCCLs), which effects are controverisial. The aim of the present study was to compare the result of restorations on NCCLs between Composite and GIC. Materials and Methods: follow-up clinical trial with split-mouth design. Thirty-six patients with 96 NCCLs were divided into 2 groups (n=48/group): Group 1 restored by Composite, Group 2 restored by GIC. The restorations were evaluated at baseline, 1 and 3 months for pulpal sensitivity, restoration morphology and overall success grade. Results: GIC restorations gained 100% Good results for all parameters at 3 time points. Composite showed 87.5%, 93.8% and 97.9% Good results at baseline, 1 and 3 months, sequentially. At 3 weeks recall, 1 Composite restorations (2.1%) showed Moderate results of Retention and 2 Composite restorations (4.2%) changed colour. Conclusions: There was no statistically significant difference seen among the three groups for 3 parameters. Key words: non-carious cervical lesion, Composite, Glass ionomer cement

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Comparison of Changes in Number of Hyperreflective Dots After İntravitreal Ranibizumab or Dexamethasone İmplant in Patients with Branch Retinal Vein Occlusion

10.21203/rs.3.rs-736656/v1 ◽

2021 ◽

Author(s):

Aylin Karalezli ◽

Sema Kaderli ◽

Ahmet Kaderli ◽

Cansu Kaya ◽

Sabahattin Sul

Keyword(s):

First Year ◽

Intravitreal Ranibizumab ◽

Retinal Layers ◽

Vein Occlusion ◽

Significant Difference ◽

Group 3 ◽

The Mean ◽

Group 2 ◽

Group 1

Abstract Purpose: To compare the effect of intravitreal ranibizumab (IVR) or intravitreal dexamethasone implants (IVD) on regression of hyperreflective dots (HRDs) on optical coherence tomography (OCT) B-scan in patients with branch retinal vein occlusion (BRVO). Methods: 37 eyes of 37 patients with cystoid macular edema who received IVR or IVD and followed up for at least 12 months were included in this study. The patients were divided into three groups according to intravitreal treatment. Group 1 consisted of 12 eyes who received only IVD, group 2 consisted of 10 eyes who received only IVR on a pro re nata and group 3 consisted of 15 eyes who received both IVD and IVR. OCT parameters (CMT, number of HRDs, status of external limiting membrane (ELM) and ellipsoid zone (EZ)) and best-corrected visual acuity (BCVA) were compared between the groups over the follow-up time. HRDs were categorized as HRD in inner retinal layers (from the internal limiting membrane to the inner nuclear layer) or HRD in outer retinal layers (from the outer plexiform layer to the outer border of the photoreceptor layer).Results: There was no significant difference between groups in terms of BCVA, CMT, HRDs in the inner and the outer retinal layers at baseline visit. (p˃0.05 for all) Comparing the baseline values in all groups, a significant decrease was observed in CMT in the first year. (For group 1; p=0.013, group 2; p=0.010; group 3, p<0.001) The BCVA was significantly increased after 1 year in all groups. (p=0.001, p=0.006, p<0.001) The mean number of HRDs in inner and outer retinal layers were significantly decreased in group 1 and group 3. (For group 1; p<0.001, p=0.001, for group 3; p<0.001, p<0.001) However, there was no significant difference in terms of the mean number of HRDs in inner and outer retinal layers for group 2. (p=0.134, p=0.477) At the first year, the number of HRDs in inner and outer retinal layers was significantly lower in group 1 and group 3 than group 2. (For inner HRDs; group 1 vs. group 2 p=0.007, group 2 vs. group 3 p<0.001. For outer HRDs group 1 vs. group 2 p<0.001, group 2 vs. group 3 p<0.001.) The BCVA was higher in group 3 than group 2 at 1year. (p=0.048). There was no significant difference in terms of post-treatment CMT and the number of HRDs between group 1 and group3 in posthoc tests (p=0.621, p=0.876, and p=0.632).Conclusion: The reduction in HRDs at 12 months and better BCVA after IVD intimates that the HRDs should be considered as inflammatory markers in the follow-up of CME in BRVO. Thus, IVD injection could be more appropriate for patients with higher HRDs after BRVO.

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

Ophthalmic Research ◽

10.1159/000512469 ◽

2020 ◽

Vol 64 (3) ◽

pp. 398-404

Author(s):

Jia Li ◽

Xu Bai ◽

Xiaoyue Guan ◽

Hongfeng Yuan ◽

Xiang Xu

Keyword(s):

Visual Acuity ◽

Adverse Events ◽

Phase 1 ◽

Optic Canal ◽

Traumatic Optic Neuropathy ◽

Corrected Visual Acuity ◽

Group 2 ◽

Best Corrected Visual Acuity ◽

Group 1

Purpose: 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). Methods: 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. Results: 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 (p > 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (p < 0.05); however, there were no statistically significant differences between the groups (p > 0.05). In addition, no adverse events related to local transplantation were observed in the patients. Conclusions: A single, local MSC transplantation in the optic nerve is safe for patients with TON.

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