High intensity focused ultrasound for glaucoma : 1-year results from a prospective pragmatic study
BACKGROUND: Ciclo plasty using high-intensity focused ultrasound (HIFU) technology acts through the selective coagulation of the ciliary body. Our aim was to evaluate the safety and efficacy profiles of 8-s probe HIFU cyclocoagulation using the EyeOP1 device.
METHODS: Prospective pragmatic trial.
INCLUSION CRITERIA: adult glaucoma patients with uncontrolled IOP despite optimised medical therapy, and/or intolerant to medical therapy required to achieve target IOP.
PRIMARY OUTCOME: surgical success defined as IOP reduction from baseline >20% with final IOP ≤21 mmHg, without adding any IOP-lowering drugs, and without loss of light perception; or decreased use of IOP-lowering drugs with stable/decreased IOP, without loss of light perception.
SECONDARY OUTCOMES: mean IOP, intra and postoperative complications, best-corrected visual acuity (BCVA) and number of IOP-lowering drugs at each visit. Outcome data were collected preoperatively and at postoperative day 1, and months 1, 3, 6 and 12.
RESULTS: Forty-nine eyes of forty-nine patients (28 male) with a mean age of 70 ± 14 years were enroled. Pre-operative IOP was 26.9 ± 7.4 mmHg under 2.8 ± 0.9 topical medications, decreasing to 17.8 ± 6.4 mmHg under 2.3 ± 1 drugs at 12 months (p < 0.01). One-year surgical success was achieved in 71.4% of patients (IOP-reduction criteria: 59.2%; decreased use of IOP-lowering drugs: 38.8%). Eight patients were ultimately submitted to other glaucoma surgical interventions. Five patients experienced serious adverse events (loss of light perception n = 5; hypotony n = 1).
CONCLUSIONS: This innovative non-invasive technology seems to be effective in decreasing IOP and/or the number of administered drops in patients with refractory glaucoma. It seems a valuable tool to delay or preclude the need for filtering procedures in the majority of the patients.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Eye (London, England) - 35(2021), 2 vom: 21. Feb., Seite 484-489 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Marques, Raquel E [VerfasserIn] |
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| Anmerkungen: |
Date Completed 18.06.2021 Date Revised 02.02.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1038/s41433-020-0878-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM309022134 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Ciclo plasty using high-intensity focused ultrasound (HIFU) technology acts through the selective coagulation of the ciliary body. Our aim was to evaluate the safety and efficacy profiles of 8-s probe HIFU cyclocoagulation using the EyeOP1 device | ||
| 520 | |a METHODS: Prospective pragmatic trial | ||
| 520 | |a INCLUSION CRITERIA: adult glaucoma patients with uncontrolled IOP despite optimised medical therapy, and/or intolerant to medical therapy required to achieve target IOP | ||
| 520 | |a PRIMARY OUTCOME: surgical success defined as IOP reduction from baseline >20% with final IOP ≤21 mmHg, without adding any IOP-lowering drugs, and without loss of light perception; or decreased use of IOP-lowering drugs with stable/decreased IOP, without loss of light perception | ||
| 520 | |a SECONDARY OUTCOMES: mean IOP, intra and postoperative complications, best-corrected visual acuity (BCVA) and number of IOP-lowering drugs at each visit. Outcome data were collected preoperatively and at postoperative day 1, and months 1, 3, 6 and 12 | ||
| 520 | |a RESULTS: Forty-nine eyes of forty-nine patients (28 male) with a mean age of 70 ± 14 years were enroled. Pre-operative IOP was 26.9 ± 7.4 mmHg under 2.8 ± 0.9 topical medications, decreasing to 17.8 ± 6.4 mmHg under 2.3 ± 1 drugs at 12 months (p < 0.01). One-year surgical success was achieved in 71.4% of patients (IOP-reduction criteria: 59.2%; decreased use of IOP-lowering drugs: 38.8%). Eight patients were ultimately submitted to other glaucoma surgical interventions. Five patients experienced serious adverse events (loss of light perception n = 5; hypotony n = 1) | ||
| 520 | |a CONCLUSIONS: This innovative non-invasive technology seems to be effective in decreasing IOP and/or the number of administered drops in patients with refractory glaucoma. It seems a valuable tool to delay or preclude the need for filtering procedures in the majority of the patients | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Ferreira, Nuno P |e verfasserin |4 aut | |
| 700 | 1 | |a Sousa, David C |e verfasserin |4 aut | |
| 700 | 1 | |a Barata, André Diogo |e verfasserin |4 aut | |
| 700 | 1 | |a Sens, Paula |e verfasserin |4 aut | |
| 700 | 1 | |a Marques-Neves, Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Abegão Pinto, Luis |e verfasserin |4 aut | |
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