Traction Treatment Research Articles

Intravitreal ocriplasmin: A breakthrough in the treatment of vitreomacular traction?

Vitreoretinal interface pathologies, such as vitreomacular traction syndrome, epiretinal membranes and macular holes are sight-threatening conditions and one of the important causes of vision defects and vision loss. To this date, vigilance with observation of how the vitreomacular traction resolves, or vitreoretinal surgery in more severe cases, were the only treatment options. Recent rapid progress in ophthalmology, especially in diagnostic and visualization techniques, provided better insight into the mechanisms taking place on the vitreoretinal surface, which enabled a more accurate selection of treatment options. Development of ophthalmic pharmacological procedures, such as treatment of vitreomacular traction syndrome with ocriplasmin, constitutes an innovative breakthrough in ophthalmology. The enzyme is a genetically engineered form of human plasmin, a component of blood coagulation cascade that has been envisioned for human therapy since 1950s. It has never been used for vitreolysis in ophthalmology before. The aim of this review is to analyze and compare therapeutic options for symptomatic vitreomacular adhesion and vitreoretinal traction, with particular emphasis on microplasmin. We reviewed the results of recent studies comparing ocriplasmin to other widespread treatment options, such as pars plana vitrectomy.

Impacted tooth associated with dentigerous cyst and compound odontoma – case report

The dentigerous cyst is a benign cyst associated with the development of odontogenic epithelium that covers the crown of impacted teeth. These are prevalent in the first three decades of life, reaching more often Caucasian males. Odontomas are hamartomas affecting the dental tissues, which can be divided into compound and complex odontoma. Odontoma affects children and young adults of both sexes, with a predilection for jaw bone. Case report: A 12-year-old boy attended the Pediatric Dentistry Clinic of Positivo University, complaining of pain in right parasymphysis region. The panoramic radiograph showed an impacted tooth (#43) located in base of the jaw below the apex of the teeth #31 to #42, with increased follicle. A radiopaque mass with small fragments of approximately 1 cm, located at the apex of the teeth #83 and #84 was seen. The patient underwent surgery under general anesthesia to remove the impacted tooth and radiopaque injury. Histopathological analysis of the dental follicle was compatible with dentigerous cyst and dental fragments were diagnosed as compound odontoma. The postoperative was uneventful, four months after the surgery the patient began orthodontic treatment for traction of tooth #44. Conclusion: Both lesions, dentigerous cyst and compound odontoma have favorable prognosis and low recurrence rate, but must be removed to maintain the integrity of the stomatognathic system. In this case was important the inter-relationship between dental specialties for the treatment of the patient.

TREATMENT OF VITREOMACULAR TRACTION WITH INTRAVITREAL PERFLUOROPROPANE (C3F8) INJECTION.

To assess the posterior vitreous release rates following a single, office-based intravitreal injection of expansile gas in treating vitreomacular traction. Thirty eyes of 29 consecutive patients with symptomatic vitreomacular traction received a single, office-based intravitreal injection of up to 0.3 mL of 100% perfluoropropane (C3F8). Overall, vitreomacular traction release occurred in 25 of 30 eyes by the final follow-up visit (83% final release rate); furthermore, 90% (9 of 10 eyes) with diabetes mellitus released, 83% (5 of 6 eyes) with concurrent epiretinal membrane released, and 83% (5 of 6 eyes) previously treated with ocriplasmin released. Vitreomacular traction release occurred overnight in some patients and was documented on spectral domain optical coherence tomography at an average of 13 days (range, 1-62 days). The phakic release rate was 89% (16 of 18 eyes) versus a 75% pseudophakic release rate (9 of 12 eyes) (P = 0.3173). Ellipsoid zone changes on spectral domain optical coherence tomography occurred in 1 of 30 gas-treated eyes. One patient developed pupillary block. Office-based intravitreal injection of C3F8 offers an inexpensive and effective treatment for vitreomacular traction, including for patients who underwent previous ocriplasmin administration and in patients with diabetes mellitus or epiretinal membrane.

Initial Clinical Experiences Using Ocriplasmin for the Treatment of Vitreomacular Traction with or without a Macular Hole

In vitreomacular traction (VMT), there is abnormal adhesion between the vitreous cortex and the retina, especially in the fovea. Symptoms of VMT include metamorphopsia and a decrease in visual acuity. Since 2013, ocriplasmin (Jetrea®) has been approved for treatment of symptomatic vitreomacular traction with or without macular holes (≤ 400 µm). We retrospectively examined twenty-three eyes of twenty-one patients who underwent intravitreal ocriplasmin treatment for symptomatic vitreomacular traction with or without macular holes. Best corrected visual acuity and central retinal thickness (CRT) were measured in advance and after ocriplasmin treatment. The numbers of resolved vitreomacular traction and closed macular holes were documented. Vitreomacular traction was resolved in eight of twenty-three eyes (34.8 %); in fifteen eyes (65.2 %) it was persistent and two of four macular holes were found closed. The average best corrected visual acuity was 0.39 ± 0.25 logMAR at baseline and 0.41 ± 0.24 logMAR at the first follow-up visit after injection (p = 0.613). The average CRT was 453.3 ± 172.7 µm at baseline, with a slight decrease to 412.0 ± 212 µm (p = 0.124). Intravitreal injection of ocriplasmin appears is an experimental therapy in patients with symptomatic vitreomacular traction. Patient selection seems to be critically important for the therapeutic outcome, whereas greater age, specific VMT morphology and missing chromatopsia seem to be negative predictors.

Coexistence of vitreomacular traction and exudative age-related macular degeneration. A case report

Vitreomacular traction is a common phenomenon causing a decrease in visual acuity, metamorphopsia, and disorders of central vision. The introduction of intravitreal ocriplasmin injection provided a new possibility of noninvasive treatment of this syndrome. The novelty of this case is that the ocriplasmin is a new treatment possibility and its combination with ranibizumab treatment has rarely been reported. The aim was to report a case of an 83-year-old man treated with intravitreal ocriplasmin and ranibizumab injections because of coexisting vitreomacular traction and exudative age-related macular degeneration. A patient was referred to our clinic due to complaints about progressive central visual acuity decrease and metamorphopsia in the right eye observed within the last year. Before intravitreal 125-μg ocriplasmin injection the patient underwent ophthalmic examinations including best corrected visual acuity, slit-lamp, and fundoscopy and optical coherence tomography. After diagnosing with exudative age-related macular degeneration the patient was referred to three loading doses of anti-VEGF therapy. Three weeks after ocriplasmin injection the patient’s best corrected visual acuity improved. Ophthalmic examinations revealed the occurrence of exudative age-related macular degeneration. After three loading doses of anti-VEGF therapy ophthalmic examinations disclosed vitreomacular traction release and retinal fluid absorption. Coexistence of vitreomacular diseases may be the reason for poor response to anti-VEGF treatment in patients with exudative age-related macular degeneration. Simultaneously, pharmacological vitreolysis using ocriplasmin injection may be an effective and safe method of vitreomacular traction treatment.

High-Force Versus Low-Force Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation: A Preliminary Randomized Trial

ObjectiveThis study compared the effects of high-force versus low-force lumbar traction in the treatment of acute lumbar sciatica secondary to disc herniation. MethodsA randomized double blind trial was performed, and 17 subjects with acute lumbar sciatica secondary to disc herniation were assigned to high-force traction at 50% body weight (BW; LT50, n = 8) or low force traction at 10% BW (LT10, n = 9) for 10 sessions in 2 weeks. Radicular pain (visual analogue scale [VAS]), lumbo-pelvic-hip complex motion (finger-to-toe test), lumbar-spine mobility (Schöber-Macrae test), nerve root compression (straight-leg-raising test), disability (EIFEL score), drug consumption, and overall evaluation of each patient were measured at days 0, 7, 1, 4, and 28. ResultsSignificant (P < .05) improvements were observed in the LT50 and LT10 groups, respectively, between day 0 and day 14 (end of treatment) for VAS (–44% and –36%), EIFEL score (–43% and –28%) and overall patient evaluation (+3.1 and +2.0 points). At that time, LT50 specifically improved in the finger-to-toe test (–42%), the straight-leg-raising test (+58), and drug consumption (–50%). No significant interaction effect (group-by-time) was revealed, and the effect of traction treatment was independent of the level of medication. During the 2-week follow-up at day 28, only the LT10 group improved (P < .05) in VAS (–52%) and EIFEL scores (–46%). During this period, no interaction effect (group-by-time) was identified, and the observed responses were independent of the level of medication. ConclusionsFor this preliminary study, patients with acute lumbar sciatica secondary to disc herniation who received 2 weeks of lumbar traction reported reduced radicular pain and functional impairment and improved well-being regardless of the traction force group to which they were assigned. The effects of the traction treatment were independent of the initial level of medication and appeared to be maintained at the 2-week follow-up.

Visual function response to ocriplasmin for the treatment of vitreomacular traction: results from the oasis study

PurposeThe effect of an intravitreal ocriplasmin‐injection on vitreomacular adhesion (VMA) resolution was investigated in a phase 3b randomized, sham‐controlled, double‐masked, multicentre study. The objective of this analysis was to assess the effect of ocriplasmin on patient‐relevant visual function outcomes.MethodsPrespecified analysis of secondary endpoints in the OASIS study. A total of 220 participants with symptomatic VMA/VMT were enrolled, of whom 146 received a single IVT‐injection of 125 μg ocriplasmin and 74 a sham‐injection. Visual function response (VFR) was defined as either a VA improvement of ≥2 lines or an improvement exceeding the minimal clinically important difference (MCID) in the composite score or the VFQ‐25 mental health subscale score of the Visual Function Questionnaire (VFQ‐25). The MCID was estimated using the standard error of measurement approach. The main outcome measure was the VFR at 6 months, with further assessments at month 12 and 24.ResultsThe MCID was estimated at 3.71 points for the VFQ‐25 composite score and 10.71 for the VFQ‐25 mental health subscale score. VFR occurred in 51.0% of ocriplasmin vs. 23.3% of sham subjects (p = 0.0001). The VFR was maintained through months 12 and 24: 53.1% and 50.3% in ocriplasmin vs. 21.9% and 20.5% in sham subjects, respectively (p &lt; 0.0001).ConclusionsTreatment with ocriplasmin compared with sham resulted in a significant improvement in VFR. The 6‐month treatment effect was sustained at month 12 and 24.

Abstract PR299

Background & Objectives: Migraine is a highly disabling primary headache disorder. Among these, chronic migraine (CM) is the most serious branch. CM is frequently triggered by insomnia and a great proportion of CM is concomitant with insomnia[1].Recommended treatment for CM and for insomnia are neither readily inaccessible nor bearing some unacceptable side effects[2-3].Our aim of this trail is to evaluate the treatment effect of stellate ganglion block(SGB) and brainwave tract treatment (BTT) in patients with CM and migraine related insomnia. Materials & Methods: A monocentric, randomized, controlled, single-blind study was conducted. Patients were randomized to receive totally drug (group O) or drug with SGB(group A) or drug with SGB and BTT(group B) for 3 months. Baseline and after 1 month and 3 months of each treatment values for the number of headache days with moderate or severe intensity per month and number of migraine days per month and number of migraine episodes per month were determined on the basis of patient reporting and medical history. Furthermore, The Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess headache-related disability. Data from brainwave traction treatment is generated automatically and it contains the health of brain and the ability of brain. All treatment-related adverse events (AEs) were recorded. Results: Of 40 randomized patients, 36 finished the study. Patients in group A and group B had a significantly reduction in headache days with moderate or severe intensity per month and number of migraine days per month and number of migraine episodes per month than patients in group O. Patients in group O has transient reduction in in those indicators at 1 month but not 3 month. However, there was no significant different in those indicators between group A and group B.HIT-6 and MIDAS scores were significantly improved in group A and group B, without group differences, but not improved in group O. PSQI score in three groups were significantly reduced without differences between groups. There were no serious treatment-related adverse events. Conclusion: Preventive drugs were not as effective as SGB in treating patients with CM and migraine related insomnia in this trail. BTT was not effective than expected, perhaps in that the sample is small or the instrument for BTT should be adjusted.

Longstanding pain and social strain: patients’ and health care providers’ experiences with fracture management by skeletal traction; a qualitative study from Malawi

Aim: The aim of the study is to contribute to a more holistic evidence based on lower limb fracture management in low-income settings, by exploring the perspectives of those actually experiencing and administering skeletal traction in Malawi.Methods: The study took place at Queen Elizabeth Central Hospital in Blantyre and Kamuzu Central Hospital in Lilongwe, the two largest public hospitals of Malawi. Qualitative data were collected by participant observation, individual interviews with eight patients, two orthopedic surgeons, one physiotherapist, and two focus group discussions with multidisciplinary teams.Results: Patients experienced physical and psychological pain from the prolonged traction treatment in bed. Anxiety, indignity and emotional distress in the ward environment were commonly observed. Patients emphasized the negative impact on their families and the significant economic consequences due to prolonged hospitalization. Health care providers identified the major obstacles for quality treatment due to the lack of staff, equipment, specialized knowledge and skills. Rehabilitation services were nearly absent, thus little effort was made to maintain function and enhance recovery during and after long-term bed confinement.Conclusion: The use of long-term skeletal traction has a devastating impact on the patients and families, and causes major frustrations to health workers involved with fracture management in a low-resource setting.Implications for RehabilitationAs stated by various health care providers, there is a need to improve trauma care, strengthen rehabilitation services and educate more rehabilitation staff so they can take up the different roles and functions required in treatment and rehabilitation after injuries and other debilitating conditions.In the current situation, sufficient pain relief for patients is required. This should go hand in hand with the empowerment of patients so as to fulfill their rights to quality health services. For health care providers, multidisciplinary teamwork, enhanced specialized education and skills, improved access to adequate equipment and developing standardized procedures appear essential in order to improve fracture management.With injuries representing a growing portion of the global burden of disease, and in the changing demographic panorama with aging populations in Africa and the world at large, injury prevention, trauma care- and rehabilitation need a stronger focus in public health globally.

Review of economic studies and budget impact analysis of ocriplasmin as a treatment of vitreomacular traction

ObjectiveTo review the evidence on the cost-effectiveness of ocriplasmin as a treatment for vitreomacular traction (VMT), and to estimate the impact on the Spanish National Health System (NHS). Material and methods(1) Systematic review. The following databases were searched in January 2015: MEDLINE, PREMEDLINE, EMBASE, CRD, the Cochrane Library, and key websites. Selection criteria were: full economic evaluations that compared ocriplasmin with usual care (‘watch and wait’ and/or vitrectomy) in patients with VMT. The outcomes to extract were costs of the alternatives and the incremental cost-effectiveness ratio. Studies of budget impact analysis were also included. The methodological quality was assessed, and a narrative synthesis of the included studies was carried out. (2) Estimation of budget impact. The impact on the budget as a result of the introduction of ocriplasmin in the NHS was estimated, including data from different sources. ResultsSix studies were identified, none of them performed in Spain. The two best studies concluded that ocriplasmin is cost-effective in their respective countries (Canada and United Kingdom), but only in patients with certain conditions (without epiretinal membrane, for example). The results of the budget impact analysis are different between countries. The analysis for Spain showed that the introduction of ocriplasmin would mean a saving over 1 million Euros for the NHS in 5 years. ConclusionsThe cost-effectiveness of ocriplasmin has not been demonstrated in Spain. However, good studies performed in other countries found that ocriplasmin is cost-effective in selected patients. Given the current prices in Spain, ocriplasmin could involve a saving for the Spanish NHS.

Ocriplasmin: who is the best candidate?

Enzymatic vitreolysis is currently the focus of attention around the world for treating vitreomacular traction and full-thickness macular hole. Induction of posterior vitreous detachment is an active area of developmental clinical and basic research. Despite exerting an incompletely elucidated physiological effect, ocriplasmin (also known as microplasmin) has been recognized to serve as a well-tolerated intravitreal injection for the treatment of vitreomacular traction and full-thickness macular hole. There are several unexplored areas of intervention where enzymatic vitreolysis could potentially be used (ie, diabetic macular edema). Recent promising studies have included combinations of enzymatic approaches and new synthetic molecules that induce complete posterior vitreous detachment as well as antiangiogenesis. Although no guidelines have been proposed for the use of ocriplasmin, this review attempts to aid physicians in answering the most important question, “Who is the best candidate?”

Revisión de estudios económicos y análisis de impacto presupuestario de la ocriplasmina como tratamiento de la tracción vitreomacular

ObjectiveTo review the evidence on the cost-effectiveness of ocriplasmin as a treatment for vitreomacular traction (VMT), and to estimate the impact on the Spanish National Health System (NHS). Material and methods1) Systematic review. The following databases were searched in January 2015: MEDLINE, PREMEDLINE, EMBASE, CRD, the Cochrane Library, and key websites. Selection criteria were: full economic evaluations that compared ocriplasmin with usual care (‘watch and wait’ and/or vitrectomy) in patients with VMT. The outcomes to extract were costs of the alternatives and the incremental cost-effectiveness ratio. Studies of budget impact analysis were also included. The methodological quality was assessed, and a narrative synthesis of the included studies was carried out. 2) Estimation of budget impact. The impact on the budget as a result of the introduction of ocriplasmin in the NHS was estimated, including data from different sources. ResultsSix studies were identified, none of them performed in Spain. The two best studies concluded that ocriplasmin is cost-effective in their respective countries (Canada and United Kingdom), but only in patients with certain conditions (without epiretinal membrane, for example). The results of the budget impact analysis are different between countries. The analysis for Spain showed that the introduction of ocriplasmin would mean a saving over 1 million Euros for the NHS in 5 years. ConclusionsThe cost-effectiveness of ocriplasmin has not been demonstrated in Spain. However, good studies performed in other countries found that ocriplasmin is cost-effective in selected patients. Given the current prices in Spain, ocriplasmin could involve a saving for the Spanish NHS.

Comparison of Guided and Unguided Ocriplasmin Injection for the Treatment of Vitreomacular Traction: A Preliminary Study.

This retrospective quality control study aimed at comparing resolution in patients treated with intravitreal ocriplasmin (IVO) using two injection techniques, classical injection procedure (unguided) and targeted injection using a surgical microscope with a 30-gauge 1-inch needle (guided) for the treatment of focal VMT without macular hole. The two groups presented a statistically significant difference in terms of resolution of VMT within the first month following treatment: 1/7 for the unguided group versus 6/7 for the guided group (p = 0.0291). The majority of the guided group presented an earlier resolution than the single resolved case in the unguided group. The results of this preliminary study indicate that the injection of ocriplasmin closer to the site of VMT results in the resolution in a higher number of cases and that this resolution occurs in a short time interval.

Clinical characteristics and selection of treatment modality for patients with vitreomacular traction: real-world implementation of NICE guidance (TA297).

AimTo investigate the qualitative aspects in patient selection and the quantitative impact of disease burden in real world treatment of vitreomacular traction (VMT) and implementation of the National Institute for Health and Care Excellence (NICE) guidance (TA297).MethodsA monocentric, retrospective review of consecutive patients undergoing optical coherence tomography (OCT) imaging over a 3 month period. Patients with VMT in at least one eye were identified for further data collection on laterality, visual acuity, symptoms, presence of epiretinal membrane, macular hole and treatment selection.ResultsA total of 3472 patients underwent OCT imaging with a total of 6878 eyes scanned. Out of 87 patients, 74 patients had unilateral VMT (38 right, 36 left) and 13 patients had bilateral VMT. Eighteen patients with unilateral VMT satisfied NICE criteria of severe sight problems in the affected eye. Eight were managed for a coexisting pathology, one refused treatment, one patient did not attend, two closed spontaneously, and one received ocriplasmin prior to the study start date. Only two patients with unilateral VMT received ocriplasmin and three underwent vitrectomy. Those failing to meet NICE criteria for unilateral VMT were predominantly asymptomatic (n=49) or had coexisting ERM (n=5) or both (n=2).ConclusionOcriplasmin provides an alternative treatment for patients with symptomatic VMT. Our data shows that the majority of patients with VMT do not meet NICE TA297 primarily due to lack of symptoms. Those meeting NICE criteria, but not treated, tended to have coexisting macular pathology. Variation in patient selection due to subjective factors not outlined in NICE guidance suggests that real world outcomes of ocriplasmin therapy should be interpreted with caution.

Cost-effectiveness of ocriplasmin for the treatment of vitreomacular traction and macular hole

BackgroundIf left untreated, vitreomacular traction (VMT) will infrequently improve through spontaneous resolution of vitreomacular adhesion (VMA), and patients remain at risk of further deterioration in vision. The mainstay of treatment for VMT is vitrectomy, an invasive procedure that carries the risk of rare but serious complications and further vision loss. As such, a ‘watch and wait’ approach is often adopted before this surgical intervention is performed. Ocriplasmin (microplasmin) is a potential alternative treatment for patients with symptomatic VMA/VMT that may remove the requirement for vitrectomy.ObjectiveThe purpose of this study was to evaluate the cost-effectiveness of ocriplasmin for the treatment of VMT in comparison to standard of care.Study designA cohort-based computer simulation model was developed, capturing three mutually exclusive subgroups: 1) VMT without epiretinal membrane (ERM) or full thickness macular hole (FTMH), 2) VMT with ERM but no FTMH, and 3) VMT with FTMH. Transition probabilities between health states, utilities, and resource utilisation were estimated based on clinical trial results, the literature, and expert opinion. The cost per quality-adjusted life year (QALY) gained was estimated over a lifetime, using UK unit costs and utilities associated with visual acuity, adverse events, metamorphopsia, and surgical interventions.SettingAnalyses were conducted from a UK payer perspective.PopulationTransition probabilities for the model were primarily estimated from patient-level data from the combined Phase 3 MIVI-TRUST trials in patients with symptomatic VMA/VMT, including when associated with a FTMH ≤400 µm.InterventionOcriplasmin (microplasmin) is a one-time intravitreal injection designed specifically to release the abnormal traction between the macula and the vitreous and thereby treat VMT, as well as macular hole with persistent vitreous attachment.Main outcome measureThe main outcome measure of the economic evaluation was cost per QALY.ResultsIn all subgroups, ocriplasmin management generated more QALYs: 1) VMT without ERM or FTMH (0.105, (0.036, 0.191)); 2) VMT with ERM but no FTMH (0.041, (0.011, 0.131)); and 3) VMT with FTMH (0.053, (−0.002, 0.113)). The initial treatment costs were partially offset by later savings and net costs were estimated at £1,901 (£1,325, £2,474), £2,491 (£1,067, £2,511), and £1,912 (£1,233, £2,506), respectively. Costs per QALY were estimated at £18,056 (£8,241, £64,874), £61,059 (£8,269, £168,664), and £36,250 (−£144,788, £290,338), respectively. Short-term efficacy parameters were found to be key drivers of results.ConclusionOcriplasmin is most cost-effective in VMT patients without either ERM or FTMH.

Initial experience with ocriplasmin in the treatment of vitreomacular traction.

This study aimed to report the clinical and structural outcomes of intravitreal ocriplasmin in the treatment of vitreomacular interface disorders in two tertiary centers in Brazil. A retrospective study was performed by reviewing medical records and spectral domain optical coherence tomography (SD-OCT) findings of seven patients who were treated with a single ocriplasmin injection. A total of 57.14% of patients achieved resolution of vitreomacular traction as evidenced by SD-OCT. Regarding our functional results, 87.71% maintained or improved visual acuity after follow-up. To the best of our knowledge, this is the first study reporting initial results of ocriplasmin therapy in Brazil.

Tetraplegia developing with skull traction in patients with ankylosing spondylitis: A case report

Introduction: traffic accidents appear to be one of the frequently encountered causes of spinal cord injury (sPI) in patients with ankylosing spondylitis. the risk of spinal cord injury is 11.4 times higher in patients with As compared to the healthy population. Although the fractures might be seen in any part of the spine, they most frequently occur in cervical region. case report: Our subject in this case is a 62-year-old patient diagnosed with As who had isolated muscle strength loss following a traffic accident. the patient was provided skull traction treatment having sustained a fracture in his c7 in a traffic accident, and he developed tetraplegia as a result. conclusion: Our objective with this case report is to emphasize that stress loading treatment methods such as skull traction which apply force to bone in fractures arising from traumas in patients with As could lead to extremely severe neurological injuries.

The effects of cervical traction, cranial rhythmic impulse, and Mckenzie exercise on headache and cervical muscle stiffness in episodic tension-type headache patients.

[Purpose] The purpose of this study was to examine the effects of cervical traction treatment, cranial rhythmic impulse treatment, a manual therapy, and McKenzie exercise, a dynamic strengthening exercise, on patients who have the neck muscle stiffness of the infrequent episodic tension-type (IETTH) headache and frequent episodic tension-type headache(FETTH), as well as to provide the basic materials for clinical interventions. [Subjects] Twenty-seven subjects (males: 15, females: 12) who were diagnosed with IETTH and FETTH after treatment by a neurologist were divided into three groups: (a cervical traction group (CTG, n=9), a cranial rhythmic contractiongroup (CRIG, n=9), and a McKenzie exercise group (MEG, n=9). An intervention was conducted for each group and the differences in their degrees of neck pain and changes in muscle tone were observed. [Results] In the within-group comparison of each group, headache significantly decreased in CTG. According to the results of the analysis of the muscle tone of the upper trapezius, there was a statistically significant difference in MEG on the right side and in CRIG on the left side. According to the results of the analysis of the muscle tone of the sternocleidomastoid muscle, there was a statistically significant difference in MEG on the right side and in CRIG on the left side. [Conclusion] In the comparison of the splenius capitis muscle between the groups, there was a statistically significant difference on the right side. Hence, compared to the other methods, cervical traction is concluded to be more effective at reducing headaches in IETTH and FETTH patients.

Cost-effectiveness analysis of ocriplasmin in the treatment of vitreomacular traction in Italy

BACKGROUND: Vitreomacular traction (VMT) caused by vitreomacular adhesion (VMA), is a pathological condition when the vitreous humor has an abnormally strong attachment to the central part of the retina. Ocriplasmin recently approved for the treatment of VMT, including when associated with macular hole (MH) of diameter less than or equal to 400 microns, is a recombinant truncated form of the human serine protease plasmin with retained enzymatic activity, administered by intravitreal injection. We estimated long-term benefits and costs associated with the resolution of traction, following treatment with ocriplasmin versus Standard of Care (SoC), from National Health Service (NHS) perspective.METHODS: A lifetime Markov model has been adopted for Italy in order to estimate costs and outcomes, gained for patients with VMT, with and without MH, treated with ocriplasmin. Health effects have been expressed as Life Years (LY) and Quality adjusted LY gained (QALY), and estimated based on time spent in Visual Acuity (VA) states, defined by best and worst seeing eye, disutility impact associated with surgical interventions, adverse events and metamorphopsia. Deterministicand probabilistic analysis have also been conducted.RESULTS: Over a lifetime ocriplasmin versus SoC generated incremental benefits in terms of QALYs and overall treatment costs in each patients subgroups. Patients with VMT and VMT+MH treated with ocriplasmin had an incremental survival benefits of 0.1123 and 0.0772 QALYs respectively. Therefore, it is expected to come at an incremental cost of 1,873 € and 2,185 € for VMT and VMT+MH patients respectively. The associated ICER is 16,683 € and 28,294 € per QALY gained. Both sensitivity analyses for each of the subgroups confirmed the robustness of the model results.CONCLUSION: Compared to SoC, ocriplasmin is a cost effective therapy option in the treatment of VMT, including whenassociated with MH.[Article in Italian]

Direct cost of pars plana vitrectomy for the treatment of macular hole, epiretinal membrane and vitreomacular traction: a bottom-up approach.

PurposeThe direct cost to the National Health Service (NHS) in England of pars plana vitrectomy (PPV) is unknown since a bottom-up costing exercise has not been undertaken. Healthcare resource group (HRG) costing relies on a top-down approach. We aimed to quantify the direct cost of intermediate complexity PPV.MethodsFive NHS vitreoretinal units prospectively recorded all consumables, equipment and staff salaries during PPV undertaken for vitreomacular traction, epiretinal membrane and macular hole. Out-of-surgery costs between admission and discharge were estimated using a representative accounting method.ResultsThe average patient time in theatre for 57 PPVs was 72 min. The average in-surgery cost for staff was £297, consumables £619, and equipment £82 (total £997). The average out-of-surgery costs were £260, including nursing and medical staff, other consumables, eye drops and hospitalisation. The total cost was therefore £1634, including 30 % overheads. This cost estimate was an under-estimate because it did not include out-of-theatre consumables or equipment. The average reimbursed HRG tariff was £1701.ConclusionsThe cost of undertaking PPV of intermediate complexity is likely to be higher than the reimbursed tariff, except for hospitals with high throughput, where amortisation costs benefit from economies of scale. Although this research was set in England, the methodology may provide a useful template for other countries.