Intracameral Phenylephrine to Arrest Intraoperative Intraocular Bleeding: A New Technique.
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ABSTRACT:
SUBMITTER: Bizrah M
PROVIDER: S-EPMC6393249 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:The purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery. METHODS:Four hundred and six patients (406 study eyes; 202 in the OMS302 group and 204 in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15 centers in the USA and the Netherlands. The patients received OMS302 (60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12 hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain. RESULTS:OMS302 was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302 - placebo) in change in the area under the curve from baseline for pupil diameter was 0.590 ([0.049]; 95% confidence interval 0.494 to 0.686; P<0.0001). For ocular pain scores, the weighted mean (standard error) difference was -4.580 ([1.192]; 95% confidence interval -6.917 to 2.244; P=0.0002). All secondary efficacy results favored OMS302. Specifically, analyses supporting prevention of miosis (patients with ?6 mm pupil diameter at completion of cortical clean-up and those with <6 mm diameter at any time during surgery) were significant for OMS302 (95.9% versus 77.0% and 9.2% versus 38.0%, respectively; P<0.0001 for each endpoint). OMS302 was well tolerated and not associated with any unexpected adverse events. CONCLUSION:OMS302 maintained mydriasis, prevented miosis, and reduced early postoperative pain when administered in irrigation solution during intraocular lens replacement, with a safety profile similar to that of placebo. OMS302 is preservative-free and bisulfite-free, and its administration does not require any modification to the surgical procedure.
| S-EPMC4161524 | biostudies-literature
Project description:Objective. To investigate mydriatic effect of intracamerally injected epinephrine hydrochloride during phacoemulsification and intraocular lens (IOL) implantation. Methods. Eighteen cataract patients for bilateral phacoemulsification were enrolled. To dilate pupil, one eye was randomly selected to receive intracamerally 1?mL epinephrine hydrochloride 0.001% for 1 minute after corneal incision (intracameral group), and the contralateral eye received 3 drops of compound tropicamide 0.5% and phenylephrine 0.5% at 5-minute intervals 30 minutes before surgery (topical group). Pupil diameters were measured before corneal incision, before ophthalmic viscoelastic device (OVD) injection, after OVD injection, before IOL implantation, and at the end of surgery. Results. At each time point, the mean pupil diameter in the intracameral group was 2.20 ± 0.08, 5.09 ± 0.20, 6.76 ± 0.19, 6.48 ± 0.18, and 5.97 ± 0.24?mm, respectively, and in the topical group it was 7.98 ± 0.15, 7.98 ± 0.15, 8.53 ± 0.14, 8.27 ± 0.16, and 7.93 ± 0.20?mm, respectively. The topical group consistently had larger mydriatic effects than the intracameral group (P < 0.05). The onset of mydriatic effect was rapid in the intracameral group. There was no difference in surgical performance or other parameters between groups. Conclusions. Intracameral epinephrine hydrochloride appears to be an alternative to the mydriatic modalities for phacoemulsification and IOL implantation. In comparison with topical mydriatics, intracameral epinephrine hydrochloride offers easier preoperative preparation, more rapid pupil dilation, and comparable surgical performance.
| S-EPMC4745390 | biostudies-literature
Project description:Preoperatively, the surgeon instills two drops of 0.5% proparacaine and then marks the 0° and 180° points at the limbus using a Gentian violet marker and 26G needle edge. Intraoperatively, after phacoemulsification and irrigation and aspiration of the cortex are complete, the surgeon inspects the previously marked 0°–180° points on the limbus. In case the steeper astigmatic meridian needs to be marked, a Mendez Ring is used and the meridian is marked using a Gentian violet marker and 26G needle edge. The desired markings (2 mm in length only) on the anterior lens capsule can be made using 26G needle bent at the bevel or using micro-vitreoretinal scissors. The toric intraocular lens (IOL) is then rotated in the bag in the desired meridian (customized-toric IOL in 0°–180° meridian and noncustomized toric IOL in steeper marked meridian), viscoelastic substance is aspirated and corneal wounds are hydrated.
| S-EPMC7787088 | biostudies-literature
Project description:The presence of emulsified silicone oil in the eye can lead to many complications, glaucoma being one of the most common. Adequate IOP control is difficult to achieve with medical management alone; surgical intervention is often required. Glaucoma drainage device implantation is often the preferred line of surgical intervention in such cases due to trabeculectomy failure from emulsified silicone oil droplets and associated conjunctival scarring. However, the silicone tube of Ahmed glaucoma valve (AGV) may attract the silicone oil droplets, causing blockade of the tube with persistent raised IOP postoperatively. We report one such case where post-AGV silicone oil tube occlusion was treated with semi-conservative surgical management instead of revising the entire surgery or implantation of another drainage device. Our surgical technique of intracameral "vent and flush" offers rapid and effective IOP control in such cases. Postoperatively, normal IOP was achieved. Patency of tube continued to be maintained along with normalization of IOP on subsequent follow-ups.
| S-EPMC9332948 | biostudies-literature
Project description:Long-term treatment of glaucoma, a major leading cause of blindness, is challenging due to poor patient compliance. Therefore, a drug delivery device that can achieve drug release over several months can be highly beneficial for glaucoma management. Here, we evaluate the long-term pharmacokinetics and therapeutic efficacy of polycaprolactone intracameral drug delivery devices in rabbit eyes. Our study showed that a single drug delivery device loaded with a proprietary hypotensive agent, DE-117, reduced intraocular pressure in normotensive rabbits significantly for 23weeks. In addition, we demonstrated that concentration of DE-117 and its hydrolyzed active form (hDE-117) was maintained in the aqueous humor and the target tissue (iris-ciliary body) up to 24weeks. Our proof-of-concept glaucoma implant shows potential as a long-term treatment that circumvents patient compliance barriers compared to current treatment via eye drops.
| S-EPMC5748363 | biostudies-literature
Project description:PurposeTo describe a flapless/grooveless technique for four-point refixation of a dislocated intraocular lens (IOL) with four fenestrated haptics.MethodsAn intraocular suture looping technique was performed with the assistance of two 27-gauge needles. A looping needle was passed into the eye through paracentesis and was used to loop both fenestrated haptics on the same side with an 8-0 polypropylene thread. A guiding needle was used to guide the looping needle out of the eye at the scleral fixation sites. After looping each pair of fenestrated haptics on nasal/temporal sides with 8-0 polypropylene sutures, the IOL was refixated by definitive knotting. The exterior suture ends were buried into the sclera without the creation of scleral flaps/grooves.ResultsThe technique was employed in four eyes (three patients). The mean postoperative follow-up period was 13.8 ± 2.2 months. Postoperatively, the IOLs of all the eyes remained well positioned and stable. The postoperative visual acuities of all the eyes were improved. No suture erosion, hypotony, scleral atrophy, chronic inflammation, retinal tears, and/or detachments were observed within the follow-up period.ConclusionThe present technique provides minimal surgical invasion for the transscleral refixation of a dislocated IOL with four fenestrated haptics.
| S-EPMC7884157 | biostudies-literature
Project description:BackgroundAppropriate blood component transfusion might differ between intraoperative massive bleeding and traumatic massive bleeding in the emergency department because trauma patients initially bleed undiluted blood and replacement typically lags behind blood loss. We compared these two blood loss scenarios, intraoperative and traumatic, using a computer simulation.MethodsWe modified the multi-compartment dynamic model developed by Hirshberg and implemented it using STELLA 9.0. In this model, blood pressure changes as blood volume fluctuates as bleeding rate and transcapillary refill rate are controlled by blood pressure. Using this simulation, we compared the intraoperative bleeding scenario with the traumatic bleeding scenario. In both scenarios, patients started to bleed at a rate of 50 ml/min. In the intraoperative bleeding scenario, fluid was administered to maintain isovolemic status; however, in the traumatic bleeding scenario, no fluid was supplied for up to 30 min and no blood was supplied for up to 50 min. Each unit of packed red blood cells (PRBC) was given when the hematocrit decreased to 27%, fresh frozen plasma (FFP) was transfused when plasma was diluted to 30%, and platelet concentrate (PC) was transfused when platelet count became 50,000/ml.ResultsIn both scenarios, the appropriate ratio of PRBC:FFP was 1:0.47 before PC transfusion, and the ratio of PRBC:FFP:platelets was 1:0.35:0.39 after initiation of PC transfusion.ConclusionThe ratio of transfused blood component did not differ between the intraoperative bleeding and traumatic bleeding scenarios.
| S-EPMC7724118 | biostudies-literature
Project description:PurposeTo describe a modified technique of haptic externalization for trocar-based sutureless scleral fixation of intraocular lenses, in order to avoid working with forceps in the iris plane in a manner that may be unfamiliar to the vitreoretinal surgeon.MethodsThis prospective, interventional case series included four eyes of four patients with dislocated intraocular lens (IOL). The modified haptic externalization technique avoids the pitfalls of iris-plane maneuvers by intentionally dropping the IOL onto the retina and using the forceps to grasp the tips of the haptics prior to direct externalization from the same grab.ResultsFour patients underwent scleral fixation of IOL using modified haptic externalization technique. One patient was lost to follow up after postoperative day 1. At the last follow up, all eyes demonstrated stability and good centration of scleral fixated IOL. All three patients achieved a best corrected visual acuity same or better compared to before the operation. One patient developed vitreous hemorrhage which later spontaneously resolved.ConclusionsThe modified haptic externalization technique is a simple and quick modification using maneuvers familiar to vitreoretinal surgeons. It has demonstrated safety among a small pilot group of patients.
| S-EPMC8233194 | biostudies-literature
Project description:We describe a modified scleral fixation method to facilitate the good centration and adequate tension of sutures at both ends with addition of an internal fixation knot that reduces decentering of the IOL in a patient with postsurgical aphakia. Using an ab externo suture technique to fixate the haptics to the scleral wall, an additional loop knot is tied 1 mm next to the fixation knot at the haptic. In the technique, an internalized suture and an additional suture knot is tied while holding it close to the fixation knot at the haptic using a needle holder or McPherson forceps. The externalized sutures are secured by taking a bite of transclera and tying the suture to itself. This technique is simple and easy, and adds an internal check valve to prevent excessive pull and decentering of the intraocular lens at one side. The internal check valve also serves as a criterion for the point of fixation at each end.
| S-EPMC6056155 | biostudies-literature
Project description:Importance:Novel oral anticoagulation and antiplatelet therapies have become a mainstay of treatment for thromboembolic disease. However, the safety profile of these medications has not been completely characterized. Objective:To determine the risk of developing intraocular hemorrhages with novel oral antithrombotic therapy compared with that of traditional antithrombotic agents. Design, Setting, and Participants:In this retrospective cohort study, a large national insurance claims database was used to generate 2 parallel analyses. All patients with incident use of dabigatran etexilate or rivaroxaban between January 1, 2010, and September 30, 2015, were compared with patients with incident use of warfarin sodium. Similarly, patients with new use of prasugrel hydrochloride were compared with those with new use of clopidogrel bisulfate. Both analyses required the patient to be in the insurance plan for at least 24 months prior to initiation of therapy and excluded patients with any previous diagnosis of intraocular hemorrhages or any prescription for the comparator medications. Furthermore, the antiplatelet analysis required a diagnosis of acute coronary syndrome or a myocardial infarction within 60 days of initiation of pharmacologic therapy. The anticoagulant analysis excluded patients with end-stage renal disease, renal transplants, and those with heart valve disease. Main Outcomes and Measures:Incident intraocular hemorrhages at 90 and 365 days. Multivariate Cox proportional hazards regression models were used to compare the hazard ratio (HR) of developing an intraocular hemorrhage in individuals taking novel agents compared with those taking traditional medications. Results:A total of 146 137 patients taking warfarin (76 714 women and 69 423 men; mean [SD] age, 69.8 [11.8] years) were compared with 64 291 patients taking dabigatran or rivaroxaban (31 576 women and 32 715 men; mean [SD] age, 67.6 [11.7] years). Cox proportional hazards regression revealed a decreased hazard for developing an intraocular hemorrhage with dabigatran or rivaroxaban at 365 days (HR, 0.75; 95% CI, 0.58-0.97; P = .03), but not at 90 days (HR, 0.73; 95% CI, 0.22-2.63; P = .13). A total of 103 796 patients taking clopidogrel (37 578 women and 66 218 men; mean [SD] age, 68.0 [11.3] years) were compared with 8386 patients taking prasugrel (1988 women and 6380 men; mean [SD] age, 61.0 [9.6] years) and no increased hazard for developing an intraocular hemorrhage with prasugrel was seen at 90 days (HR, 0.75; 95% CI, 0.29-1.92; P = .55) or 365 days (HR, 1.19; 95% CI, 0.69-2.04; P = .53). Conclusions and Relevance:These results suggest a decreased risk of intraocular hemorrhage associated with novel direct thrombin inhibitors and direct factor Xa inhibitors, but no difference for P2Y12 inhibitors compared with traditional vitamin K anticoagulation and antiplatelet therapy, respectively.
| S-EPMC5838600 | biostudies-literature