Efficiency of a polymer-coated phacoemulsification tip in cataract surgery.

PURPOSE: To determine whether there is a difference in efficiency during phacoemulsification when using the hybrid polymer tip compared with the metal balanced tip, as measured by cumulative dissipated energy (CDE) and total procedure time. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah. DESIGN: Experimental study. METHODS: Phacoemulsification was performed with the Centurion Vision System and Infiniti OZil handpiece, with a 30-degree bevel metal balanced tip and hybrid polymer tip. The vacuum was set at 500 mm Hg and the aspiration flow rate at 50 mL/min. Power was changed for torsional and longitudinal ultrasound (US) at 20%, 40%, 60%, 80%, and 100%. Hardened porcine lenses were cut into 200 two mm cubes, 10 for each specified tip/power setting. They were placed into an artificial anterior chamber filled with a balanced salt solution, and phacoemulsification was performed. A second observer randomly assigned the US type and power. The same observer timed trials with a stopwatch, and CDE was recorded. RESULTS: There were no significant differences in time or CDE for any power levels or US modes when comparing the 2 tips. CONCLUSIONS: No significant difference in efficiency was observed when comparing the metal balanced tip with the hybrid polymer tip. Given the known improved safety profile and the overall equivalent efficiency of the hybrid tip, it could improve the performance of beginning and advanced surgeons in the future. Future study is needed to evaluate other setting combinations and to evaluate the hybrid tip in clinical settings.

Temperature Change of Ophthalmic Viscosurgical Devices in a Bi-Chamber Set-Up at a Flow of 0 and 20mL/min.

Purpose: To understand the role of ophthalmic viscosurgical devices (OVDs) in corneal incision contracture (CIC). Specifically, the aim was to evaluate with the tip of the phacoemulsification needle free of OVD, how various OVDs near the tip and sleeve may transmit thermal energy to the incision site. Methods: A small chamber was filled with balanced saline solution (BSS), and a thin membrane was placed on the surface. OVD was placed atop the membrane. A temperature probe was placed in the OVD, while the handpiece pierced the membrane. The experiment was run both with and without flow and vacuum. Temperature measurements were gathered for each of the OVDs at four separate time points at 0 and 20mL/min flow. Results: As expected, there was a more pronounced temperature increase in all test groups with no fluid flow. While the temperature increase was not significantly different from BSS for any of the OVDs tested at either 0 or 20mL/min, Viscoat showed the most variable results at both flow settings. Conclusion: As long as the phaco tip is not in OVD, residual OVD near the incision is not exothermic and so not an additional risk for CIC.

Comparison of Phacoemulsification Grooving Efficiency in Longitudinal vs Transversal Handpieces.

Purpose: To determine the difference, if any, in grooving efficiency at various settings on the Whitestar Signature Pro phacoemulsification (phaco) system. Methods: Cataractous lenses were simulated by exposing porcine lenses to formalin for 2 hours. A total of 120 lenses were analyzed at various power settings on both longitudinal and transversal handpieces. Twenty trials each were performed with power set to 25%, 50%, and 75% on both handpieces. A Whitestar Phaco Handpiece System was used to provide longitudinal power, and a Whitestar Signature Ellipsis Handpiece provided transversal power. Lenses were placed within a plastic chamber and grooved by an investigator blinded to settings. A second investigator recorded times and adjusted settings. The Whitestar Signature Pro phaco system was used for grooving. Results: There was no significant difference in grooving times between the longitudinal and transverse handpieces at any power setting (P > 0.05). There was a significant decrease in grooving times when comparing the 25% power setting with the 75% power setting for the transversal handpiece (P=0.021). Conclusion: Both longitudinal and transversal handpieces on the Whitestar Signature Pro phaco system produce similar results to one another at each power setting. There is a general trend toward shorter grooving times, reflecting greater efficiency, at higher power settings. Grooving efficiency on the transversal handpiece may be more affected by changes in the power settings as compared with the longitudinal settings.

Measurement of Phacoemulsification Vacuum Pressure in the Oertli CataRhex3.

Purpose: To determine the actual vacuum pressure generated by the Oertli CataRhex 3® (Oertli), using an external measuring system. Methods: The effective vacuum pressure created by the Oertli was measured with a pressure device that was continuous with the vacuum tubing system while closed to the external environment. Measurements were taken with the machine set to 300 and 500 mmHg at flow rates of 20, 35, and 50 mL/min and at bottle heights of 60, 80, and 100 cm. Pressures were recorded after the foot pedal was depressed to vacuum setting (second position), and the pressure was allowed to stabilize. Subsequently, it was compared to the pressure value displayed by the machine. Results: Externally measured vacuum pressure was on average 13.02% greater (39.05 mmHg) than displayed vacuum pressure at 300 mmHg (P < 0.005) and 8.60% greater (42.98 mmHg) than displayed vacuum at 500 mmHg (P < 0.005). The average difference between displayed and measured pressure increased with increasing bottle heights. Conclusion: On average, the vacuum pressure generated in the Oertli was found to be significantly higher than the machine's reading when the machine was set at 300 mmHg and 500 mmHg. Adjusting vacuum had variable effects on the measured versus displayed pressure readings.

Optimization of Phacoemulsification Tip Gauge on the Oertli CataRhex3 in an in vitro Setting.

Purpose: To evaluate the effect of each of the tip sizes available for the Oertli CataRhex3® phacoemulsification machine on efficiency. Methods: Porcine lenses were fixed in formalin for 2 hours, then cut into 3.0 mm cubes. We studied three Oertli tips, all of which had a 30-degree bevel: easyTip 2.2 mm (20G), easyTip 2.8 mm (19G), and CO-MICS (21G). For the 19G and 20G tips, vacuum was set at 600 mmHg, irrigation rate at 50 mL/min, continuous power 70%, and bottle height 85 cm. For the 21G tip, vacuum was set at 450 mmHg; irrigation and power settings were identical to those used for the easyTip tips. We measured time to removal and chatter events to determine efficiency. Results: Results from 20 trials for each tip showed that the larger the gauge size, the more quickly lens fragments were removed. Chatter events demonstrated an increasing trend with smaller tip gauge. The 19G tip used an average time to fragment removal of 2.8 seconds; the 20G, 3.2 seconds; and the 21G, 4.6 seconds. Increasing tip diameter from 21G to 20G decreased emulsification time by 33% (P = 0.02). Increasing the diameter from 21G to 19G further decreased time to emulsification by 42% (P = 0.003). The 21G tip had a mean 1.4 events/cube; 20G, 0.35 events; and 19G, 0.1 events. Differences in mean chatter events for each tip were each statistically significant. Conclusion: These data suggest that when evaluated by chatter events and emulsification time, the 2.8 mm (19G) easyTip proves to have greatest efficiency.

Optimizing Tip Diameter in Phacoemulsification of Varying Lens Sizes: An in vitro Study.

PURPOSE: We assessed the effect of two lens cube sizes, three tip sizes, and two ultrasound (US) approaches on phacoemulsification efficiency and chatter. METHODS: After porcine lens nuclei were soaked in formalin, we divided them into cubes measuring 2.0 mm or 3.0 mm. We collected efficiency and chatter data for 30-degree bent 19 G, 20 G, and 21 G tips with a continuous torsional US system; and for straight 19 G, 20 G, and 21 G tips with a micropulse longitudinal US system. RESULTS: The average time needed for removal was always higher for the 3.0 mm lens cube than for the 2.0 mm lens cube. Statistically significant differences were observed between the 19 G and 21 G tips with micropulse longitudinal US using a 2.0 mm cube and a 3.0 mm cube, and with continuous transversal US using a 2.0 mm lens cube and a 3.0 mm cube. We did not observe significant differences between 19 G and 20 G tips with either cube size in either US system. However, we noted identical trends for both cube sizes with both US approaches; 19 G tips performed better than 20 G and 21 G tips. CONCLUSION: Regardless of the lens size, 19 G needles were the most efficient, and had both the fewest outliers and the smallest standard deviations.

Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM).

Belantamab mafodotin (belamaf) demonstrated deep and durable responses in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM) in DREAMM-2 (NCT03525678). Corneal events, specifically keratopathy (including superficial punctate keratopathy and/or microcyst-like epithelial changes (MECs), eye examination findings with/without symptoms), were common, consistent with reports from other antibody-drug conjugates. Given the novel nature of corneal events in RRMM management, guidelines are required for their prompt identification and appropriate management. Eye examination findings from DREAMM-2 and insights from hematology/oncology investigators and ophthalmologists, including corneal specialists, were collated and used to develop corneal event management guidelines. The following recommendations were formulated: close collaboration among hematologist/oncologists and eye care professionals is needed, in part, to provide optimal care in relation to the belamaf benefit-risk profile. Patients receiving belamaf should undergo eye examinations before and during every treatment cycle and promptly upon worsening of symptoms. Severity of corneal events should be determined based on corneal examination findings and changes in best-corrected visual acuity. Treatment decisions, including dose modifications, should be based on the most severe finding present. These guidelines are recommended for the assessment and management of belamaf-associated ocular events to help mitigate ocular risk and enable patients to continue to experience a clinical benefit with belamaf.

Correction to: Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.

The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.

Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.

INTRODUCTION: Patients with relapsed or refractory multiple myeloma (RRMM) represent an unmet clinical need. Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F (MMAF), to myeloma cells. In the phase II DREAMM-2 study (NCT03525678), single-agent belamaf (2.5 mg/kg) demonstrated clinically meaningful anti-myeloma activity (overall response rate 32%) in patients with heavily pretreated disease. Microcyst-like epithelial changes (MECs) were common, consistent with reports from other MMAF-containing ADCs. METHODS: Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected. A literature review on corneal events reported with other ADCs was performed. RESULTS: In most patients receiving single-agent belamaf (72%; 68/95), MECs were observed by slit lamp microscopy early in treatment (69% had their first event by dose 4). However, IVCM revealed hyperreflective material. Blurred vision (25%) and dry eye (15%) were commonly reported symptoms. Management of MECs included dose delays (47%)/reductions (25%), with few patients discontinuing due to MECs (1%). The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date. A literature review confirmed that similar MECs were reported with other ADCs; however, event management strategies varied. The pathophysiology of MECs is unclear, though the ADC cytotoxic payload may contribute to on- or off-target effects on corneal epithelial cells. CONCLUSION: Single-agent belamaf represents a new treatment option for patients with RRMM. As with other ADCs, MECs were observed and additional research is warranted to determine their pathophysiology. A multidisciplinary approach, involving close collaboration between eye care professionals and hematologist/oncologists, is needed to determine appropriate diagnosis and management of these patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT03525678.

Effects on phacoemulsification efficiency and chatter at variable longitudinal ultrasound settings when combined with constant torsional energy.

PURPOSE: To evaluate longitudinal power settings for optimally efficient lens fragment removal, using the Centurion machine. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, USA. DESIGN: Experimental study. METHODS: Porcine lens nuclei were cut into 2.0 mm cubes. Experiments were conducted at 100% torsional power; vacuum set at 500 mm Hg, aspiration 50 mL/min, and intraocular pressure 110 mm Hg. A 20-degree tip with a 30-degree bevel was used. Longitudinal power was tested between 20% and 100%. Efficiency (time for fragment removal) and chatter (the number of times the fragment bounced from the tip) were measured. RESULTS: A linear increase in efficiency was observed from 20% to 100% longitudinal power (R = 0.9281, slope = -0.0271). An efficiency slope change occurred at 60% power, with the largest incremental change in efficiency between 20% and 60% (R = 0.9756, slope = -0.0394) and a lesser change between 60% and 100% (R = 0.9827, slope = -0.0121). Chatter analysis showed minimal events at 20% to 60%, but a significant increase at >80% (P = .005). This increase appeared to be incremental (R = 0.8929). CONCLUSIONS: Increasing longitudinal power, with all other settings constant, increased efficiency. Greatest efficiency gains were observed between 20% and 60%. At 80% and 100%, chatter events increased significantly. With a goal of recommending optimally efficient settings while minimizing excess energy and chatter, adding 60% of longitudinal power to 100% torsional power was shown to be the best setting to increase efficiency and avoid repulsion in these vacuum and aspiration settings.

Optimum on-time and off-time combinations for micropulse phacoemulsification in venturi vacuum mode.

PURPOSE: To measure the time to fragment removal and number of chatter events using various combinations of micropulse on times and off times (measured in milliseconds) of longitudinal ultrasound (US) using a venturi-based phacoemulsification system. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, USA. DESIGN: Experimental study. METHODS: Pig lenses were hardened with formalin and cut into 2.0 mm cubes. The time to fragment removal (efficiency) and frequency of fragments bouncing off the tip (chatter) were measured with the venturi-based system. Micropulse longitudinal US was tested. Parameters were combinations of 5, 6, and 7 milliseconds on, with 5, 6, and 7 milliseconds off. Twenty runs each of 9 combinations were completed. RESULTS: There was a statistically significant difference between on/off duty cycle combinations. The 6 on/7 off group had higher efficiency than the 5 on/6 off and 7 on/7 off groups. Six on/5 off was more efficient than 5 on/6 off. When data were pooled and on times alone were used, 6 milliseconds on time was more efficient than 5 or 7 milliseconds. No efficiency differences in off times were found. No significant chatter differences were observed. CONCLUSIONS: Using micropulse longitudinal US in venturi vacuum mode, 6 milliseconds on was the most efficient on time. Five, 6, and 7 milliseconds off times had similar efficiency. These data suggest that the most efficient setting with lowest US energy use is 6 milliseconds on and 7 milliseconds off.

Impact of torsional micropulse on phacoemulsification efficiency and chatter.

OBJECTIVE: Evaluate the effect of increasing ultrasound (US) power on chatter events and efficiency under both continuous and micropulse torsional US to reduce total cataract extraction times. DESIGN: In vitro laboratory study. METHODS: Porcine lens nuclei were incubated in formalin for 2 hours and then cut into 2-mm cubes. Phacoemulsification was performed using the Centurion Vision System and Infiniti OZil handpiece with the balanced tip. Both US modalities were studied at 60%, 80%, and 100% power. Micropulse rate was 83 pulses per second with 50% on time. Each combination comprised 20 runs. Efficiency was considered as the total time for a cube to be emulsified; chatter was the number of times the lens fragment bounced off the tip. RESULTS: There was significant decrease in efficiency when power was increased from 60% to 100% (1.33-1.97 s; p < 0.001) under micropulse US and significant increase in chatter when power was further increased to 100% from 60% (0.15-0.94 s; p < 0.001). There was no significant efficiency change with increased power under continuous US. Comparing the phacoemulsification efficiency between continuous and micropulse US, we found no significant difference at 60% and 80% power; at 100% power, continuous was significantly more efficient than micropulse (1.48 and 1.97 s, respectively; p = 0.001). CONCLUSIONS: Increasing power above 60% decreased efficiency under torsional micropulse US. We believe that this was due to the chatter increase observed with increasing US power. Torsional continuous US was significantly more efficient than micropulse US at 100% power.

Phacoemulsification in review: Optimization of cataract removal in an in vitro setting.

Phacoemulsification, initially used in the late 1960s, continues to be the standard of care for cataract removal. An animal model was developed so that, in a controlled research setting, all the various machines, handpieces, tips, and settings could be investigated. As a general rule, the higher power, vacuum, and aspiration settings lead to optimally efficient phacoemulsification. In addition, both new phacoemulsification platforms and newly developed devices have been shown to improve efficiency. As a result, we recommend that the integration of these recent developments should be considered in future investigations.

Optimization of the Oertli CataRhex 3® phacoemulsification machine.

PURPOSE: The aim of this study was to determine optimal bottle height, vacuum, aspiration rate, and power settings of the Oertli CataRhex 3® phacoemulsification machine. METHODS: Porcine lens nuclei were hardened with formalin and cut into 2.0 mm cubes. Lens cubes were emulsified using the easyTip® 2.2 mm at 30°. Fragment removal time (efficiency) and fragment bounces off the tip (chatter) were measured. Settings tested included bottle height of 60, 80, 100 and 120 cm; aspiration rate of 40, 45, and 50 mL/min; vacuum of 400, 500, and 600 mmHg; and power of 50, 60, 70, 80, 90, and 100%. RESULTS: Efficiency and chatter increased in a linear fashion with increasing vacuum to 600 mmHg (P=0.017, P=0.046, respectively). The most efficient aspiration rate was 50 mL/min, although this finding lacked statistical significance (P=0.66). Increasing power increased efficiency up to 80% without increasing chatter (P=0.042, P=0.71, respectively). Compared to all other power settings, chatter was increased at 100% (P=0.014). CONCLUSION: The most efficient machine settings were vacuum at 600 mmHg, aspiration rate at 50 mL/min, and power at 80%.

The effect of increasing power when grooving using phacoemulsification.

PURPOSE: To determine optimal power settings on the Centurion Vision System during the grooving step in cataract surgery. METHODS: Intact porcine lenses hardened by formalin and placed in a chamber designed to simulate the anterior chamber of the eye were used to test longitudinal power at 40%, 70%, and 100% and torsional power at 0%. Flow rate was set at 40 mL/min. Vacuum was set at 400 mmHg, intraocular pressure was set at 50 mmHg, and a balanced phacoemulsification tip with a 20 degree tip and a 30 degree bevel was used. Efficiency (time to groove the lens in half) was determined. RESULTS: Increasing longitudinal power from 40% to 70% increased efficiency by 28% (P<0.05), and by 32% (P<0.05) when increasing longitudinal power from 40% to 100%. There was no statistically significant increase in efficiency from 70% to 100%. CONCLUSION: For the tested variables, a longitudinal power of 70% was determined to be most efficient during the grooving step of cataract surgery for equivalent 3-4+ nuclei. Further increases in power demonstrated no statistically significant improvement in efficiency.

Determining optimal ultrasound percent on time with long-pulse torsional phacoemulsification.

OBJECTIVE: To evaluate the optimum percent on time for the most efficient lens fragment removal using long-pulse torsional ultrasound (US). DESIGN: In vitro laboratory study. METHODS: Porcine lens nuclei were incubated in formalin for 2 hours and then cut into 2 mm cubes. Phacoemulsification was performed using the Centurion® Vision System and Infiniti OZil handpiece with the balanced tip. Vacuum was set at 500 mm Hg, aspiration rate at 50 mL/min, and intraocular pressure (IOP) at 50 mm Hg. Pulse rate was 26 pulses/second. Studied parameters were percent power: 60%, 80%, and 100%, and percent on times: 50%, 60%, 70%, and 80%. Efficiency was the total time for a cube to be emulsified. Chatter was the number of times the lens fragment bounced off the tip. RESULTS: There was no significant difference in efficiency between 50%, 60%, and 70 % on-time settings (p = 0.17 and 0.08, respectively); however, there was significant increase in efficiency when the on time was increased from 70% to 80% (p = 0.03). Increasing power from 60% to 100% showed a statistically significant efficiency increase (p = 0.001). There was no significant change in chatter with increasing on time; however, there was a statistically significant increase in chatter with every power level increase. CONCLUSION: Increasing on-time percent does not improve efficiency under torsional long-pulse US. There is no significant change in chatter with increasing on-time percent. Increasing power increases efficiency despite chatter increase. Long-pulse US does not appear to influence torsional action in a clinically meaningful way.

High vacuum and aspiration on phacoemulsification efficiency and chatter for Centurion.

OBJECTIVE: To compare relative efficiency and chatter of high aspiration and vacuum settings. DESIGN: In vitro laboratory study. METHODS: The John A. Moran Eye Center Laboratories, University of Utah, Salt Lake City, Utah, was the study setting. Porcine nuclei were fixed in formalin and cut into 2.0 mm cubes. Lens cubes were phacoemulsified with Balanced tips at 50 and 60 mL/min aspiration with 500, 600, and 700 mm Hg vacuum with monitored forced infusion. Experiments were conducted at constant torsional power, longitudinal power, and intraocular pressure. RESULTS: No significant change was observed in average chatter across each tested setting. Increasing aspiration rate did not increase efficiency. Increasing vacuum up to 600 mm Hg from 500 mm Hg did not change efficiency. However, increasing vacuum to 700 mm Hg decreased efficiency (p = 0.008 for 500 mm Hg vs 700 mm Hg and p = 0.05 for 600 mm Hg vs 700 mm Hg). Increasing aspiration and increasing vacuum did not significantly improve chatter. CONCLUSIONS: Increasing aspiration above 50 mL/min did not improve phacoemulsification efficiency. Increasing vacuum settings to 700 mm Hg decreases efficiency. Chatter did not significantly change with increasing aspiration and vacuum settings.

An unusual case of idiopathic calcinosis of the eyelid.

Idiopathic subepidermal calcinosis, also known as idiopathic calcinosis cutis, is a rare condition, which typically presents as a small, hard, subepithelial mass in the absence of systemic disease and trauma. We report on an atypical case of idiopathic calcinosis, which appeared in an otherwise healthy 61-year-old female along the tarsus of her right upper eyelid. The purpose of this case report is to demonstrate idiopathic calcinosis in an unusual location that is deep to the dermis and to discuss the vast differential diagnosis of this entity.

Effect of high vacuum and aspiration on phacoemulsification efficiency and chatter using a transversal ultrasound machine.

PURPOSE: To examine the role of high vacuum and aspiration settings on efficiency using a transversal ultrasound (US) machine. SETTING: John A. Moran Eye Center Laboratory, University of Utah, Salt Lake City, Utah, USA. DESIGN: Experimental study. METHODS: Porcine lens nuclei were incubated in formalin for 2 hours and then cut into 2.0 mm cubes. Phacoemulsification was performed using the Whitestar Signature machine. Settings were bottle height 50 cm, on-time 6 milliseconds, and off-time 6 milliseconds. One hundred percent power was used for all 240 runs. Tested parameters were aspiration of 50 mL/min and 60 mL/min and vacuum of 500, mm Hg, 600 mm Hg, and 650 mm Hg. RESULTS: With continuous US, increasing aspiration from 50 mL/min to 60 mL/min significantly increased efficiency (23%). Increasing vacuum from 500 mm Hg to 650 mm Hg and from 600 mm Hg to 650 mm Hg significantly increased efficiency (20.2% and 13.6%, respectively). Higher vacuum and aspiration parameters did not influence the incidence of chatter events. In the micropulse US group, there was no significant efficiency increase with increasing vacuum or aspiration levels. There was a significant efficiency increase of continuous over micropulse US at an aspiration setting of 60 mL/min and vacuum settings of 600 mm Hg and 650 mm Hg. CONCLUSIONS: As aspiration and vacuum increased, efficiency increased under continuous transverse US. No significant efficiency improvement occurred at high aspiration and vacuum settings under micropulse US. At 60 mL/min aspiration and more than 600 mm Hg vacuum, continuous power was significantly more efficient than micropulse transverse US.