New Glaucoma Surgical Alternatives

Shaarawy, Tarek; Moschos, Marilita M; Sherwood, Mark B.

doi:10.1016/b978-0-7020-5193-7.00128-x

Cited by 89 publications

(136 citation statements)

References 52 publications

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“…However, these success criteria have been previously used in several previous glaucoma surgical trials, particularly in the three main clinical studies evaluating the new ultrasonic ciliary body coagulation device, therefore facilitating comparisons of treatments outcomes among studies (Shaarawy et al 2009;Aptel et al 2011Aptel et al , 2014aDenis et al 2015). We found a mean IOP reduction of 30% in all patients treated, with an IOP decrease more than 20% in 63% of the patients (mean IOP reduction of 37% in those patients).…”

Section: Retreatmentmentioning

confidence: 64%

“…This study was designed, conducted and reported according to the World Glaucoma Association guidelines on the design and reporting of glaucoma surgical trials (Shaarawy et al 2009). …”

Section: Methodsmentioning

confidence: 99%

“…Subjects in which the number of hypotensive medications was increased after the procedure were considered as failure, regardless of the IOP results. Vision-threatening complications were the number of standardized severe complications defined in the World Glaucoma Association guidelines on the design and reporting of glaucoma surgical trials (Shaarawy et al 2009). Secondary outcomes were mean IOP at each follow-up visit compared with baseline, medication use, complications and reinterventions.…”

Section: Procedures and Follow-upmentioning

confidence: 99%

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Multicenter clinical trial of high‐intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery

Aptel

Denis

Rouland

et al. 2015

Acta Ophthalmologica

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ABSTRACT.Purpose: To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma na€ ıve of previous filtering surgery. Methods: Prospective non-comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open-angle glaucoma, intra-ocular pressure (IOP) > 21 mmHg and with no previous filtering glaucoma surgeries were sonicated with a probe comprising six piezoelectric transducers. The six transducers were activated with a 6-s exposure time. Complete ophthalmic examinations were performed before the procedure and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after the procedure. Primary outcomes were qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP > 5 mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP > 5 mmHg and IOP < 21 mmHg with possible re-intervention and without hypotensive medication adjunction) at the last follow-up visit and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visit compared with baseline, medication use, complications and re-interventions. Results: Intra-ocular pressure was significantly reduced (p < 0.05) from a mean pre-operative value of 28.2 AE 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 AE 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Qualified success was achieved in 63% of eyes (19/30) (mean IOP reduction of 37% in these eyes) and complete success in 46.7% of eyes (14/30) (mean IOP reduction of 37% in these eyes) at the last follow-up. No major intra-or post-operative complications occurred. Conclusions: The UC 3 procedure seems to be an effective and well-tolerated method to reduce IOP in patients with open-angle glaucoma without previous filtering surgery.

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Section: Retreatmentmentioning

confidence: 64%

“…This study was designed, conducted and reported according to the World Glaucoma Association guidelines on the design and reporting of glaucoma surgical trials (Shaarawy et al 2009). …”

Section: Methodsmentioning

confidence: 99%

Section: Procedures and Follow-upmentioning

confidence: 99%

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Multicenter clinical trial of high‐intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery

Aptel

Denis

Rouland

et al. 2015

Acta Ophthalmologica

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“…Критериями оценки эффективности проведенной операции являлись динамика ВГД, частота осложнений, необходимость применения дополнительных гипотензивных капель и проведения повторно-го хирургического вмешательства. Успешность проведенной операции оценивали согласно реко-мендациям Всемирной глаукомной ассоциации (World Glaucoma Association) [13]. Критериями по-ложительной оценки являлись снижение истин-ного ВГД (Ро) после операции до целевого уровня или 18 мм рт.…”

Section: материал и методыunclassified

Intraocular Pressure Reduction in Open-Angle Glaucoma After Segmentary Dilation of Schlemm’s Canal Using in-House Second Generation Intracanal Expander

Кумар¹,

Фролов²,

Душина³

et al. 2016

Alʹm. klin. med.

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Результаты снижения внутриглазного давления у пациентов с открытоугольной глаукомой при сегментарном расширении шлеммова канала с помощью интраканального экспандера второго поколения собственной конструкцииАктуальность. Важную роль в развитии гла-укомного процесса играют коллапс шлеммо-ва канала (ШК) и повышенное сопротивление на уровне трабекулярной ткани, особенно ее юкстаканаликулярной части. Расширение ШК и умеренное растяжение трабекулярной ткани создают благоприятные условия для восста-новления естественных путей оттока внутри-глазной жидкости. Для этой цели нами был раз-работан экспандер ШК 1-го поколения (ЭШК-1) и в клинической практике доказана его эффек-тивность в снижении внутриглазного давления (ВГД) у больных с открытоугольной глаукомой. Однако размеры данного экспандера не соот-ветствуют естественным размерам ШК, вслед-ствие чего его имплантация травматична для структур ШК. В связи с этим предложен экспан-дер ШК 2-го поколения (ЭШК-2) с уменьшенны-ми размерами.Цель -оценка эффективности ЭШК-2 в сниже-нии ВГД у больных с открытоугольной глауко-мой.Материал и методы. В анализ включены 25 пациентов (25 глаз) с открытоугольной глау-комой. Пациентам опытной группы (13 пациен-тов, 13 глаз) была выполнена антиглаукомная операция с применением ЭШК-2. Полученные данные сравнили с результатами после имплан-тации ЭШК-1 у больных контрольной группы

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“…The definition of an outcome includes five elements,3 with the outcome ‘domain’ being the name of the outcome being measured. At this time, intraocular pressure (IOP) is an outcome domain for which all glaucoma drugs have been approved by the US Food and Drug Administration4 and is the only modifiable risk factor for glaucoma 5. IOP, considered a surrogate outcome, might be a reasonable outcome domain for early efficacy trials;5 however, IOP is not a direct measure of structural or functional glaucomatous optic neuropathy.…”

Section: Introductionmentioning

confidence: 99%

Missed opportunity from randomised controlled trials of medical interventions for open-angle glaucoma

et al. 2017

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Purpose To evaluate the extent to which intraocular pressure and visual field have been reported as outcomes in randomised controlled trials (also referred to as ‘trials’) of medical treatments for open-angle glaucoma. Methods We identified published reports of trials in a systematic review of medical interventions for open-angle glaucoma our group conducted. We assessed whether intraocular pressure and visual field were reported as trial outcomes and classified them to be either completely or incompletely reported for meta-analysis. We also collected data on the length of time patients were followed and source of funding for the trial. Results As of March 2014, we identified 401 trials that had enrolled 76 861 participants. Eighty per cent of 401 trials provided complete information on intraocular pressure and 11% of the 401 trials provided complete information on visual field. Only a minority of trials followed patients for at least 1 year. About half of all reports in our study stated that receiving funding from the industry. Conclusions Although the vast majority of trials provided sufficient data for meta-analysis of the effect of medical management of open-angle glaucoma on intraocular pressure, relatively few provided data for analysing the effect on visual field. We considered this as missed opportunity because the data were not available for evidence synthesis. Investigators have an obligation to patients and providers to determine the comparative effectiveness of glaucoma interventions in terms of patient-important outcomes and not to waste data that could have been collected in trials.

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New Glaucoma Surgical Alternatives

Cited by 89 publications

References 52 publications

Multicenter clinical trial of high‐intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery

Multicenter clinical trial of high‐intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery

Intraocular Pressure Reduction in Open-Angle Glaucoma After Segmentary Dilation of Schlemm’s Canal Using in-House Second Generation Intracanal Expander

Missed opportunity from randomised controlled trials of medical interventions for open-angle glaucoma

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