Ultrasonic Circular Cyclocoagulation Research Articles

Ultrasonic circular cyclocoagulation prospective safety and effectiveness study.

To evaluate the efficacy and safety of ultrasound cycloplasty procedures (UCP) in patients with uncontrolled glaucoma. Prospective longitudinal study with UCP was performed by EyeOP1© probe with 8s duration on 6 or 8 sectors, according to baseline intraocular pressure (IOP). Complete ophthalmic examination was performed pre- and post-operatively at 1st day, 1st week, 1st, 3rd, 6th, 9th and 12th months. UCP was repeated beyond 3rd month if IOP was > 21mmHg, under maximum therapy, without major complications. Primary outcomes were complete (IOP reduction ≥ 20% or reduction in number of antiglaucomatous drugs and IOP ≥ 5mmHg without occurrence of major complications) and qualified (IOP reduction ≥ 20% or reduction in number of antiglaucomatous drugs and IOP ≥ 5mmHg) surgical success rates at 12months. Secondary outcomes were mean IOP reduction, mean number of drugs reduction, rates of failure, number of repeated procedures, mean time to failure and occurrence of complications. Fourteen eyes of 13 patients (11 male) with advanced glaucoma (Hoddap classification) were included. Six were surgically naïve. Mean age was 68.29 ± 10.66years. Four eyes were treated in 8 sectors (28.5%). Patients were followed for 12months after first UCP procedure. Overall surgical success was achieved in 92.9% at 6months and in 100% of cases at 12months. Mean IOP significantly reduced from 28.50 ± 7.61mmHg to 13.79 ± 6.97 at 1month, 17.36 ± 8.58 at 3months, 17.79 ± 6.29 at 6months, 16.3 ± 4.6 at 9months and to 15.23 ± 5.09 at 12months (p < 0.01). Mean number of drugs reduced from 3.71 ± 0.61 to 2.43 ± 1.51 at 3months, 2.86 ± 1.1 at 6months, 2.64 ± 0.93 at 9months and to 2.92 ± 0.86 at 12months (p < 0.05). Major reversible complications included choroidal detachment in 2 (14.29%) and corneal edema in 1 eye (7.14%), without permanent visual acuity reduction. Minor reversible complications included anterior chamber reaction (92.25%), conjunctival hyperemia (71.43%) and superficial keratitis (57.4%). Four eyes (28.57%) had indication for repeating UCP, with mean period to failure of 8.1 ± 3.95months. UCP procedures are effective in reducing IOP in severe glaucoma. Its application and repetition seem to be a medium-long term acceptable alternative to cyclodestructive surgery. However, long-term efficacy and safety require yet further investigation.

Efficacy and safety of ultrasonic circular cyclocoagulation with second-generation probe in glaucoma: A retrospective study.

BackgroundTo assess the efficacy and safety of the second-generation probe of ultrasonic circular cyclocoagulation (UC3) in naive or refractory glaucoma, with a 6-month follow-up.MethodsA retrospective consecutive case-series study included patients having a UC3 procedure with the second-generation probe of the EyeOP1 device, intraocular pressure (IOP) ≥ 21 mmHg and under maximum tolerated medical treatment, with or without previous glaucoma surgery. Surgical success was defined at the 6-month post-operative visit as IOP > 5 and ≤ 21 mmHg with IOP reduction ≥ 20% from baseline, without any reoperation, and visual acuity better than negative light perception.Results100 patients were included and 97 (97.0%; 97 eyes) attended the 6-month follow-up. At 6 months, surgical success was obtained in 48 eyes (49.5%). Intraocular pressure was reduced from a mean ± SD preoperative value of 28.0 ± 5.6 mmHg to 19.3 ± 7.1 mmHg at 6 months (p<0.0001). The proportion of eyes requiring oral acetazolamide decreased from 57.0% to 30.0% between baseline and 6 months after surgery (p = 0.0007). We observed 15 (15.0%) cases of postsurgical macular edema, 8 (8.0%) of hypotony, and 20 (20.0%) of visual acuity loss > 2 Snellen lines. Postsurgical macular edema was associated with a history of epiretinal membranes, uveitis or retinal detachment. Risk factors for hypotony were a history of diabetes or trabeculectomy.ConclusionsThe second-generation UC3 probe significantly reduced IOP in eyes with naive and refractory glaucoma but severe post-operative complications were often observed. Further studies are needed to better identify responders and decrease the high risk for complications associated with the procedure.

Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma.

To evaluate long-term efficacy and safety of repeated ultrasonic circular cyclocoagulation (UCCC) in patients with uncontrolled glaucoma. Forty eyes of 40 patients affected by primary or secondary uncontrolled glaucoma under maximal tolerated medical therapy were enrolled in this prospective non-comparative case series study. A complete ophthalmic examination was performed before and after each month for 1year. The UCCC treatment was repeated at 4months if the intraocular pressure (IOP) was >21mmHg without major complications. Complete success was defined as a final IOP>5mmHg and ≤21mmHg without hypotensive medication adjunction and no major or vision-threatening complications. The mean preoperative IOP was 32.5±9.9mmHg. Four months after the first UCCC treatment the overall IOP reduction was 27.8%. Twenty-two of the treated eyes did not achieve the complete success and a second treatment was performed in 20 of these eyes. Four months after the second UCCC procedure, the IOP reduction was 20.3% from preoperative values and 34.7% from baseline. Twelve of the retreated eyes needed a third treatment. Four months after the third UCCC treatment, the overall IOP reduction was 34% and 52.6% from baseline. No major complications occurred during or after any of the procedures. At 12months, complete success was achieved in 85% (34/40) of treated eyes, with a maximum of three procedures and a significant medication reduction. Multiple UCCC treatments are safe, and additional treatments increase the overall procedure efficacy.

Uveo-scleral outflow pathways after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study

AimsTo evaluate, using anterior segment optical coherence tomography (AS-OCT) and in vivo confocal microscopy (IVCM), the uveo-scleral aqueous humour (AH) outflow pathways after ultrasonic circular cyclocoagulation (UCCC).MethodsForty-four patients with refractory...

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

To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open-angle glaucoma naïve of previous filtering surgery. 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)>21mmHg 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 1day, 1week, 1, 2, 3, 6 and 12months after the procedure. Primary outcomes were qualified surgical success (defined as IOP reduction from baseline ≥20% and IOP>5mmHg with possible re-intervention and without hypotensive medication adjunction) and complete surgical success (defined as IOP reduction from baseline ≥20%, IOP>5mmHg and IOP<21mmHg 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. Intra-ocular pressure was significantly reduced (p<0.05) from a mean pre-operative value of 28.2±7.2mmHg (n=3.6 hypotensive medications) to 19.6±7.9mmHg at 12months (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. 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.

Multicenter Clinical Trial of High‐Intensity Focused Ultrasound Treatment in Glaucoma Patients without Previous Filtering Surgery

PurposeTo evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open‐angle glaucoma naïve of previous filtering surgery.MethodsProspective non‐comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open‐angle glaucoma, intraocular pressure (IOP) &gt;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 surgical success (defined as IOP reduction from baseline ≥20% and IOP &gt;5 mmHg with possible retreatment 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 to baseline, medication use, complications and retreatments.ResultsIOP was significantly reduced (p &lt; 0.05) from a mean preoperative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Success was achieved in 63% of eyes (19/30) at 12 months (mean IOP reduction of 37% in these eyes). No major intra‐ or postoperative complications occurred.ConclusionsThe ultrasonic circular cyclocoagulation procedure seems to be an effective and well‐tolerated method to reduce IOP in patients with open‐angle glaucoma without previous filtering surgery.

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

PurposeTo evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation procedure in patients with open‐angle glaucoma naïve of previous filtering surgery.MethodsProspective non‐comparative interventional clinical study conducted in five French University Hospitals. Thirty eyes of 30 patients with open‐angle glaucoma, intraocular pressure (IOP) &gt; 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 surgical success (defined as IOP reduction from baseline ≥ 20% and IOP &gt; 5 mmHg with possible retreatment 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 to baseline, medication use, complications and retreatments.ResultsIOP was significantly reduced (p &lt; 0.05) from a mean preoperative value of 28.2 ± 7.2 mmHg (n = 3.6 hypotensive medications) to 19.6 ± 7.9 mmHg at 12 months (n = 3.1 hypotensive medications and n = 1.1 procedures) (mean IOP reduction of 30%). Success was achieved in 63% of eyes (19/30) at 12 months (mean IOP reduction of 37% in these eyes). No major intra‐ or postoperative complications occurred.ConclusionsThe ultrasonic circular cyclocoagulation procedure seems to be an effective and well‐tolerated method to reduce IOP in patients with open‐angle glaucoma without previous filtering surgery.

Noninvasive glaucoma procedures: current options and future innovations.

Noninvasive glaucoma procedures (NIGPs) represent a new dawn in the management of glaucoma. They try to fill the gap between the shortcoming of invasive glaucoma surgeries and antiglaucoma medications. NIGPs were introduced as an adjunct or alternative treatments for glaucoma. Some of these procedures have shown good efficacy with few serious complications. Hence, they are now used as both primary and adjunctive therapy for glaucoma. The most common NIGPS involve laser and ultrasound technologies. Currently, the portfolio of NIGPs includes argon laser trabeculoplasty, selective laser trabeculoplasty, and micropulse diode laser trabeculoplasty. More recent innovations include therapeutic ultrasound for glaucoma, ultrasonic circular cyclocoagulation, and deep wave trabeculoplasty.

Multicenter clinical trial of ultrasonic circular cyclo coagulation in glaucoma patients naive of filtering surgery. Preliminary results at 6 months

AbstractPurpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients naive of previous filtering glaucoma surgery.Methods Prospective non comparative interventional clinical study performed in 5 French glaucoma centers. Thirty eyes of 30 patients (24 primary open‐angle glaucoma and 6 secondary glaucoma), with intraocular pressure (IOP) &gt; 21 mmHg, naïve of previous filtering glaucoma surgeries, were insonified with a therapy probe comprising 6 piezoelectric transducers. The 6 transducers were activated with a 6 seconds exposure time. Complete ophthalmic examinations were performed before the procedure, and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after. Primary outcomes were surgical success (defined as IOP reduction from baseline ≥ 20% and IOP &gt; 5mmHg) at the last follow‐up visit, and vision‐threatening complications. Secondary outcomes were mean IOP at each follow‐up visits compared to baseline, medication use, and complications.Results IOP was significantly reduced (p&lt;0.05), from a mean preoperative value of 28.3 ± 7.0 mmHg to a mean value of 19.5 ± 7.2 mmHg at 6 months. Success (IOP reduction &gt;20%) was achieved in 63% of eyes at 6 months after one HIFU procedure, with a mean IOP decrease of 39%. No major intra‐ or post‐operative complications occurred.Conclusion Ultrasonic Circular Cyclo Coagulation seems to be an effective and well tolerated method to reduce intraocular pressure in glaucoma patients naïve of previous glaucoma surgery. Commercial interest

Treatment of refractory open-angle glaucoma using ultrasonic circular cyclocoagulation: a prospective case series

Objective:To evaluate the efficacy and safety of the ultrasonic circular cyclocoagulation (UC3) procedure in patients with refractory primary open-angle glaucoma.Research design and methods:Prospective non-comparative interventional case series performed in two French glaucoma centers. Twenty-eight eyes of 28 patients with primary open-angle glaucoma, intraocular pressure (IOP) >21 mmHg, an average of 1.4 failed previous surgeries and an average of 3.8 hypotensive medications were insonified with a therapy probe comprising six piezoelectric transducers. The six transducers were activated and all patients were treated with a 6 second exposure time. Complete ophthalmic examinations were performed before the procedure, and at 1 day, 1 week, 1, 2, 3, 6 and 12 months after.Main outcome measures:Primary outcomes were surgical success (defined as IOP reduction from baseline ≥20% and IOP >5 mmHg) at the last follow-up visit, and vision-threatening complications. Secondary outcomes were mean IOP at each follow-up visit compared to baseline, medication use, complications, and re-interventions.Results:IOP was significantly reduced (P < 0.05), from a mean preoperative value of 29.0 ± 7.2 mmHg (n = 3.8 hypotensive medications) to a mean value of 21.6 ± 9.4 mmHg at last follow-up (n = 3.8 hypotensive medications and n = 1.29 procedures) (mean IOP reduction of 26%). Complete success (IOP reduction >20% without re-intervention and without hypotensive medications adjunction) was achieved in 50% of eyes at last follow-up (mean IOP reduction of 45% in these same eyes) and qualified success (IOP reduction >20% with possible re-interventions) was achieved in 68% of eyes at last follow-up. No major intra- or post-operative complications occurred.Conclusions:UC3 procedure seems to be an effective and well tolerated method to reduce intraocular pressure in patients with primary open-angle glaucoma. Studies directly comparing the efficacy and safety of the UC3 procedure with that of trabeculectomy or diode laser are needed.

Ultrasonic circular cyclo coagulation in patients with primary open‐angle glaucoma: A multicenter clinical trial

AbstractPurpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with primary open‐angle glaucoma (POAG).Methods Prospective multicenter clinical trial. 42 eyes of 42 patients with POAG, intraocular pressure (IOP) &gt; 21 mmHg, an average of 1.65 failed previous surgeries and an average of 3.2 hypotensive medications were insonified with a probe comprising 6 piezoelectric transducers. 18 patients (group 1) were treated with a 4 seconds exposure time for each shot and 24 patients (group 2) with a 6 seconds exposure time. Follow‐up visits were performed at 1 day, 1 week, 1, 2, 3, 6 and 12 months after.Results IOP was significantly reduced in both groups (p&lt;0.05), from a mean preoperative value of 28.6 ± 4.7 mmHg in group 1 and 28.1 ± 8.6 mmHg in group 2 to a mean value of 16.1 ± 2.8 mmHg in group 1 and 16.7 ± 4.4 mmHg in group 2 at last follow‐up. Success (IOP reduction &gt;20%) was achieved in 12 of 18 (67%) eyes of the group 1 and in 17 of 24 (71%) eyes of the group 2. Four patients were re‐treated. No major intra‐ or post‐operative complications occurred.Conclusion UC3 seems to be an effective and well‐tolerated method to reduce intraocular pressure in patients with POAG. Commercial interest

Ultrasonic circular cyclo coagulation in patients with primary open‐angle glaucoma: preliminary results of a multicenter clinical trial

AbstractPurpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with primary open‐angle glaucoma (POAG).Methods Prospective multicenter clinical trial. 39 eyes of 39 patients with POAG, intraocular pressure (IOP) &gt; 21 mmHg, an average of 1.65 failed previous surgeries and an average of 3.2 hypotensive medications were insonified with a probe comprising 6 piezoelectric transducers. 18 patients (group 1) were treated with a 4 seconds exposure time for each shot and 21 patients (group 2) with a 6 seconds exposure time. Follow‐up visits were performed at 1 day, 1 week, 1, 2, 3, 6 and 12 months after.Results IOP was significantly reduced in both groups (p&lt;0.05), from a mean preoperative value of 28.9 ± 6.8 mmHg in group 1 and 29.2 ± 6.9 mmHg in group 2 to a mean value of 18.1 ± 4.4 mmHg in group 1 and 16.1 ± 8,5 mmHg in group 2 at last follow‐up. Success (IOP reduction &gt;20%) was achieved in 15 of 18 (83%) eyes of the group 1 with an average of IOP decrease of 42% and in 19 of 21 (90%) eyes of the group 2 with an average of IOP decrease of 49%. No major intra‐ or post‐operative complications occurred.Conclusion UC3 seems to be an effective and well‐tolerated method to reduce intraocular pressure in patients with POAG. Commercial interest

Miniaturized High-Intensity Focused Ultrasound Device in Patients with Glaucoma: A Clinical Pilot Study

To evaluate the relative safety and potential efficacy of high-intensity focused ultrasound cyclocoagulation by a miniaturized annular device containing six piezoceramic transducers in patients with refractory glaucoma. This was a three-center prospective interventional pilot study. Twelve eyes of 12 patients with refractory glaucoma were insonified using a ring-shaped probe containing six miniaturized high-frequency transducers operating at 21 MHz. Ultrasound biomicroscopy (UBM) and a complete ophthalmic examination were performed before the procedure and at 1 day, 1 week, 1 month, and 3 months after the procedure. Additional visits were performed 6 and 12 months after the procedure. Intraocular pressure was significantly reduced (P < 0.01) from a mean preoperative value of 37.9 ± 10.7 mm Hg to a mean postoperative value of 27.3 ± 12.4, 25.2 ± 11.3, 25.2 ± 7.7, 24.8 ± 9.8, and 26.3 ± 5.1 mm Hg at 1 day, 1 week, 1 month, 3 months, and 6 months, respectively, and to a mean value of 24.7 ± 8.5 at the last follow-up visit. No major intraoperative or postoperative complications occurred. Minor postoperative corneal complications developed in four patients with previous corneal abnormalities: superficial punctate keratitis (n = 3) and central superficial corneal ulceration (n = 1). UBM showed cystic involution of the ciliary body in 9 of the 12 eyes and a suprachoroidal fluid space in 8 of the 12 eyes. Ultrasonic circular cyclocoagulation using high-intensity focused ultrasound delivered by a circular miniaturized device containing six piezoceramic transducers seems to be an effective and well-tolerated method to reduce intraocular pressure in patients with refractory glaucoma.