scholarly journals Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II

2021 ◽  
pp. 112067212110065
Author(s):  
Sophie Lemmens ◽  
Luca Rossetti ◽  
Francesco Oddone ◽  
Gordana Sunaric-Mégevand ◽  
Anton Hommer ◽  
...  

Importance: This study compares the efficacy and tolerability of a preservative-free prostaglandin analogue (tafluprost 15 mg/ml) to a prostaglandin analogue that uses 0.02% of benzalkonium chloride (bimatoprost 0.1 mg/ml). Background: Different prostaglandin analogues have been commercially approved, with differences in tolerability. Design: Prospective, randomised, investigator-masked, 3-month crossover, multicentre trial. Participants: Sixty-four patients with ocular hypertension or open-angle glaucoma were randomised to two groups, after a 4-week washout period from their current topical drop regimen. Methods: Participants were randomised to tafluprost (Group 1; n = 33) or bimatoprost (Group 2; n = 31). At month 3, each group switched to the opposite treatment. IOP was evaluated at multiple timepoints. Main outcome measures: The primary outcome was difference in mean IOP between the two groups at the final visit. Secondary outcomes included change from baseline IOP at month 3 and month 6, difference in mean IOP at month 3 and difference in IOP at all timepoints. Safety outcomes included best-corrected visual acuity (BCVA), adverse events, ocular tolerability, optic nerve assessment and slit lamp biomicroscopy. Results: Both medications significantly lowered IOP at month 6 compared to baseline: 5.4 mmHg (27%) for tafluprost and 6.8 mmHg (33%) for bimatoprost ( p < 0.0001). No significant differences in any of the safety measures (including conjunctival hypearemia) were detected. Conclusions and relevance: Bimatoprost produced a statistically significant greater IOP reduction compared to tafluprost with minimal to no difference in side effects. This should be borne in mind when weighing up the pros and cons of preserved versus preservative-free prostaglandin analogue therapy. ClinicalTrials.gov Identifier NCT02471105.

2021 ◽  
Vol 21 (3) ◽  
pp. 129-134
Author(s):  
D.A. Dorofeev ◽  
◽  
V.P. Balukhtina ◽  
M.V. Es’kova ◽  
K.A. Efimova ◽  
...  

Aim: to evaluate additive IOP-lowering effect of brimonidine 0.2% to achieve target IOP via enhancing maximum tolerated medical therapy for primary open-angle glaucoma (POAG). Patients and Methods: 63 patients (63 eyes) with advanced POAG and poorly controlled IOP who received prostaglandin analogs and a fixeddose carbonic anhydrase inhibitor/beta-blocker combination were enrolled. All patients were additionally prescribed with brimonidine 0.2%. After a month, patients were divided into two groups based on achieved IOP level. In group 1, target IOP was achieved, and these patients were followed up. In group 2, target IOP was not achieved, and these patients underwent trabeculectomy. IOP was measured by elastotonometry and using the iCare tonometer. Results: a month after prescribing α2 agonist, true IOP level reduced to 14.0 (9.5; 17.0) mm Hg in group 1 and to 17.0 (13.0; 20.0) mm Hg in group 2. At the final visit, IOP levels were within target ranges in both groups, i.e., 13.0 (11.0; 18.5) mm Hg and 13.5 (9.7; 17.2) mm Hg, respectively. Meanwhile, changes in IOP measured by various methods were significantly different. IOP reduced by 5.4% (-7.1%; 17.6%) in group 1 and by 20.7% (4.4%; 30.7%) in group 2 (p<0.05) as measured by elastotonometry and by 8.3% (-11.8%; 28.6%) in group 1 and by 33.3% (13.9%; 50.7%) in group 2 as measured by iCare tonometer. Conclusions: brimonidine 0.2% provides additional IOP reduction to enhance maximum tolerated medical therapy for advanced POAG. An estimated effect of brimonidine is a 8% reduction of IOP from the baseline. If target IOP is not achieved, a patient should be scheduled for surgery. IOP should be measured using the iCare tonometer since this device is more sensitive to minor IOP fluctuations. Keywords: brimonidine 0.2%, maximum tolerated medical therapy for glaucoma, tonometry, elastotonometry, glaucoma, trabeculectomy, additive effect, target IOP. For citation: Dorofeev D.A., Balukhtina V.P., Es’kova M.V. et al. Additive effect of brimonidine in maximum tolerated medical therapy for primary open-angle glaucoma. Russian Journal of Clinical Ophthalmology. 2021;21(3):129–134 (in Russ.). DOI: 10.32364/2311-7729-2021-21-3-129-134.


2021 ◽  
Vol 13 (3) ◽  
pp. 200-210
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.


2012 ◽  
Vol 46 (4) ◽  
pp. 172-176
Author(s):  
Sukhsagar Ratol ◽  
Rani Walia ◽  
Mridu Chaudhry

ABSTRACT Background Glaucoma is a leading cause of irreversible blindness. The fundamental problem in medical management of glaucoma is of patient compliance. An ideal drug or a drug combination is needed to slow the progression of this majorly symptomless disease. Aim To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and methods A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at a tertiary care hospital. Patients were randomized to group 1, (fixed combination (FC) latanoprost and timolol eye drops, once daily in evening) and group 2, (FC dorzolamide and timolol eye drops, twice daily). At baseline, 2, 4 and 12 weeks, IOP was recorded at 9 AM and 12 noon. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92 mm Hg (p = 0.001) in group 1 and 9.22 (p = 0.001) in group 2. The reduction in IOP in both groups 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p = 0.013 and 0.002 respectively) as compared to group 2. Conclusion The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timolol in reducing mean diurnal IOP and both treatments were well tolerated. To confirm further such studies are required. How to cite this article Ratol S, Walia R, Chaudhry M. A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension. J Postgrad Med Edu Res 2012;46(4):172-176.


Author(s):  
E.L. Sorokin ◽  
◽  
N.V. Postupaeva ◽  
◽  

Purpose. Evaluation of the efficacy of descemethogoniopuncture (DGP) at various times after microinvasive non-penetrating deep sclerectomy (MNPDS) in patients with glaucoma. Material and methods. The analysis of the results of DGP in 64 eyes of patients with primary open-angle glaucoma after previously performed MNPDS. According to the timing of DGP after MNPDS, the patients were divided into 3 groups. In the 1st group BPH was performed after 1–2 months (22 eyes), the 2nd group – after 3–4 months (21 eyes), the 3rd group after 5–6 months (21 eyes). The follow-up period was 1 year. Results. The level of intraocular pressure before DGP averaged 15.1±0.6 mm Hg in group 1, 17.5±0.9 mm Hg in group 2, and group – 18.6±0.7 mm Hg. After DGP, 13.1±0.4 mm Hg, 14.6±0.7 mm Hg, 16.1±0.5 mm Hg respectively. According to ultrasound biomicroscopy, the highest and extended intrascleral cavities and tunnels, as well as a thin loose trabeculodescemet membrane (TDM), were observed in the eyes of the 1st group. With an increase in the time after MNPDS, there was a compaction of TDM, a decrease in the height and length of the intrascleral cavity and tunnels. 12 months after DGP, the most pronounced antihypertensive effect without antihypertensive therapy occurred in group 1 – 55% of cases compared with groups 2 and 3 (33% and 14% respectively). Conclusion. The greatest efficiency was shown by performing DGP within 1–2 months after MNPDS, which is associated with the minimum development of proliferative processes in the intrascleral outflow tract in the early stages after this operation. Key words: descemethogoniopuncture, microinvasive non-penetrating deep sclerectomy, intraocular pressure, hypotensive effect, glaucoma.


Acta Medica ◽  
2021 ◽  
pp. 1-5
Author(s):  
Özlem Dikmetaş ◽  
Sepideh Lotfisadigh, ◽  
Merve Kaşıkçı ◽  
Ali Bülent Çankaya ◽  
Sibel Kocabeyoğlu

Objective: To examine the effectiveness and results of primary trabeculectomy with 5-fluorouracil (group 1) or mitomycin-C (group 2) in elderly patients. Materials and Methods: This was a retrospective study including 67 eyes with primary open-angle glaucoma that underwent primary trabeculectomy with group 1 or group 2. Patients who were followed up for less than 1 year or were under 55 years of age were excluded from the study. Surgical success was evaluated according to a decrease in cup/disk ratio and reduction of intraocular pressure without any topical medication. Results: The mean ages of participants were 65.7 years (range 59–88) and 65.9 years (range 59–74) in groups 1 and 2, respectively. The mean preoperative and postoperative intraocular pressure values were 31.3 ± 5.7 mmHg (range 17–46) and 14.8 ± 0.4 mmHg (range 10–21) in group 1 (p < 0.001) and 31.5 ± 7.4 mmHg (range 18–52) and 14.8 ± 2.9 mmHg (range 10–21) in group 2 (p < 0.001). Conclusion: The use of 5-fluorouracil or mitomycin-C during primary trabeculectomy is associated with high postoperative success rates. There were no significant differences between 5-fluorouracil and mitomycin-C in terms of intraocular pressure reduction.


2015 ◽  
Vol 22 (2) ◽  
pp. 188-194
Author(s):  
Mohammod Feroz Amin ◽  
Syeda Rezina Sultana ◽  
Indrajit Prasad ◽  
Muhammad Abdur Rahim ◽  
Md Anisur Rahman ◽  
...  

Context: Non Alcoholic Fatty liver disease (NAFLD) is a hepatic manifestation of metabolic syndrome. The pathogenesis of steatosis and cellular injury is thought to be related mostly to insulin resistance. Insulin sensitizing drugs showed promising results in number of trials. This was an open label clinical trial in newly detected glucose intolerant patients with NAFLD, to evaluate the effectiveness and superiority of pioglitazone and metformin combination to metformin alone. Methods: Forty nine patients with newly detected abnormal glucose tolerance, naïve to any anti diabetic drug, were randomly selected, from the gastroenterology out-patient department of BIRDEM Hospital, Dhaka, with the findings of ultasonographic changes of fatty liver and raised ALT and assigned to 6 months treatment with pioglitazone 30 mg plus metformin 1700 mg daily (Group 1, n=27) or only metformin 1700 mg alone (Group 2, n=22). Results: Mean age of the study population was 45.80±8.54 years, Male female distribution of the study subjects were 65.3% and 34.7% respectively. Significant reduction of ALT, F, ABF, HbA1c, cholesterol, triglyceride of the study population were achieved either by metformin alone or with combination after six months (visit 1 vs visit 3, ALT: 97.99+22. vs 55±17.49 u/ l; Fasting sugar: 9.1+1.9 vs6.64±0.94, mmol/l; ABF: 13.3±2.5 vs 8.69±1.21 mmol/l; HBA1c: 8.1±0.9 vs 6.87±0.57%; Cholesterol: 205.9±30.1 vs 186.12±22.26 mg/dl; TG: 230.4+48.1 vs 166.2±31.82). In comparison between two groups, Group 1 had found to be significantly better glycemic control compared to their counterpart at the end of 6 months (Group 1 vs Group 2, FBG: 6.37±0.56 vs 6.98±1.2; ABF: 8.34±0.84 vs 9.1±1.46; serum cholesterol, TG, and ALT levels were also found to be significant change as Cholesterol: 178.89±18.59 vs 195±23.55 mg/dl; TG: 155.85±20.99 vs 178.91±38.24 mg/ dl; ALT: 55±17.49 vs 45.74±12.63 u/L. In final visit, ultrasonographic change also found to be significantlyimproved from fatty change to normal in patients with both metformin and pioglitazone group than patients on metformin alone. Conclusion: Treatment of NAFLD of newly detected Type 2 DM or IGT patients with high ALT by both metformin and pioglitazone is more effective in reduction of ALT and lipids and also able to reverse the severity of fatty changes of liver towards normal significantly. DOI: http://dx.doi.org/10.3329/jdmc.v22i2.21540 J Dhaka Medical College, Vol. 22, No.2, October, 2013, Page 188-194


2021 ◽  
Vol 8 ◽  
Author(s):  
Weijia Zhang ◽  
Yiwei Wang ◽  
Chen Xin ◽  
Yang Sun ◽  
Kai Cao ◽  
...  

Background: Circumferential trabeculotomy have evolved from ab externo to ab interno approach. Both procedures may lower IOP, but it is unclear which maybe a superior approach.Purpose: To compare the outcomes of ab interno and ab externo circumferential trabeculotomy in patients with primary open-angle glaucoma.Design: Retrospective, comparative case series.Participants: Primary open angle glaucoma patients undergoing ab interno (40 patients in Group 1) or ab externo (54 patients in Group 2) circumferential trabeculotomy, with about one half of them having prior incisional glaucoma surgery.Methods: Outcomes including intraocular pressure (IOP), glaucoma medications and surgical complications were analyzed.Main Outcome Measures: IOP, medications and surgical success defined as an IOP of ≤ 21 mmHg and a reduction of IOP ≥20% from baseline (criterion A) or IOP ≤ 18 mmHg and a reduction of IOP 20% from baseline (criterion B) with (qualified success) or without (complete success) medications.Results: At 1 year, IOP decreased by 37.1% (26.0–14.8 mmHg) in Group 1 and 39.5% (28.5–15.1 mmHg) in Group 2. Medications decreased from 3.5 in Group 1 and 3.6 in Group 2 pre-operatively to 0.6 ± 1.0 and 0.3 ± 0.6 post-operatively, respectively. Success rates did not differ significantly between groups based on criterion A (complete and qualified success: 68.7 and 81.9% in Group 1, and 75.3 and 90.4% in Group 2, respectively) or criterion B (complete and qualified success: 58.2 and 79.3%in Group 1, and 69.5 and 88.4% in Group 2, respectively). For eyes with prior filtration surgeries, the mean percent reduction of IOP (41.7 ± 32.7% in Group 1, 39.7 ± 27.8% in Group 2, P = 0.724) and the mean medication reduction (2.9 ± 1.6 in Group 1, 3.4 ± 1.0 in Group 2, P = 0.454) were not significantly different.Conclusions: Ab interno circumferential trabeculotomy achieved comparable outcomes to ab externo trabeculotomy and may be an effective surgical option for patients with primary open-angle glaucoma.


2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Antonio M. Fea ◽  
Giulia Consolandi ◽  
Giulia Pignata ◽  
Paola Maria Loredana Cannizzo ◽  
Carlo Lavia ◽  
...  

Purpose. To compare the corneal endothelial cell loss after phacoemulsification, alone or combined with microinvasive glaucoma surgery (MIGS), in nonglaucomatous versus primary open angle glaucoma (POAG) eyes affected by age-related cataract.Methods. 62 eyes of 62 patients were divided into group 1 (n=25, affected by age-related cataract) and group 2 (n=37, affected by age-related cataract and POAG). All patients underwent cataract surgery. Group 2 was divided into subgroups A (n=19, cataract surgery alone) and B (n=18, cataract surgery and MIGS). Prior to and 6 months after surgery the patients’ endothelium was studied. Main outcomes were CD (cell density), SD (standard deviation), CV (coefficient of variation), and 6A (hexagonality coefficient) variations after surgeries.Results. There were no significant differences among the groups concerning preoperative endothelial parameters. The differences in CD before and after surgery were significant in all groups: 9.1% in group 1, 17.24% in group 2A, and 11.71% in group 2B. All endothelial parameters did not significantly change after surgery.Conclusions. Phacoemulsification determined a loss of endothelial cells in all groups. After surgery the change in endothelial parameters after MIGS was comparable to the ones of patients who underwent cataract surgery alone.


2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Chiara Posarelli ◽  
Pierluigi Ortenzio ◽  
Antonio Ferreras ◽  
Mario Damiano Toro ◽  
Andrea Passani ◽  
...  

Aim. This study assessed the 24 h circadian rhythm of intraocular pressure (IOP) using a contact lens sensor in three groups of patients with open-angle glaucoma. Methods. This study was a monocentric, cross-sectional, nonrandomized, prospective, pilot study. Eighty-nine patients were enrolled: 29 patients previously underwent an Ex-PRESS mini glaucoma device procedure (Group 1), 28 patients previously underwent Hydrus microstent implantation (Group 2), and 32 patients were currently being treated medically for primary open-angle glaucoma (Group 3). Circadian rhythm patterns were considered with five circadian indicators: fluctuation ranges, maximum, minimum, acrophase (time of peak value), and bathyphase (time of trough value). A two-tailed Mann–Whitney U-test was used to evaluate differences between groups. Results. All subjects exhibited a circadian rhythm and a nocturnal pattern. The signal fluctuation range was significantly smaller in the surgical groups than in the medically treated group (Group 1 vs. Group 3, p=0.003; Group 2 vs. Group 3, p=0.010). Subjects who underwent the Ex-PRESS procedure (Group 1) exhibited significant differences compared with the drug therapy group (Group 3) with regard to the minimum value (p=0.015), acrophase (p=0.009), and bathyphase (p=0.002). The other circadian indicators were not significantly different among groups. Conclusions. Patients who underwent IOP-lowering surgery had an intrinsic nyctohemeral rhythm. Both surgical procedures, Ex-PRESS and Hydrus, were associated with smaller signal fluctuations compared with medical treatment.


Author(s):  
Ersan Cetınkaya ◽  
Sibel Inan ◽  
Kenan Yıgıt ◽  
Mehmet Cem Sabaner ◽  
Ümit Übeyt Inan

Objective: To investigate the changes in macular retinal layers and panretinal neuroretinal functions in the long-term follow-up of patients with primary open-angle glaucoma. Materials and Methods: Forty-one patients diagnosed with primary open-angle glaucoma were followed up for 12 months. According to their mean deviation (MD) values), the patients were put into two groups as Group 1 with early stage glaucoma (MD≥-6) and Group 2 with middle-advanced stage glaucoma (MD<-6). Optical coherence tomography (OCT) and multifocal electroretinography (mfERG) were performed at the baseline and at the sixth- and 12th-month evaluations. The OCT, retinal layer and mfERG findings were compared between the two groups. Results: There was no statistically significant difference between the groups in terms of gender and age In Group 2, the mean baseline macula Retina Nerve Fiber Layer, Ganglion Cell Layer and Inner Pleksiform Layer measurements were lower in each quadrant compared to Group 1. Concerning progression in OCT measurements, there was no significant difference between the two groups. However, it was noteworthy that in Group 2, there was a decrease especially in the first and second ring amplitudes of the P1 and N2 waves and prolongation of the implicit time. At the 12-month evaluation, there was prolongation of the implicit time of the N1 wave and a decrease in the P1 wave amplitude in Group 1. Conclusion: Retinal layers are affected in patients with intermediate and advanced stage glaucoma. In the follow-up of early stage glaucoma patients, mfERG measurements can show damage that may occur.


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