Dataset Information

SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design.

ABSTRACT:

Purpose

To evaluate the incidence of intravitreal silicone oil (SO) droplets associated with intravitreal injections using a staked-on vs luer cone syringe design in the SCORE (Standard Care vs COrticosteroid in REtinal Vein Occlusion) Study.

Design

Prospective, randomized, phase III clinical trial.

Methods

The incidence of intravitreal SO was compared among participants exposed to the staked-on syringe design, the luer cone syringe design, or both of the syringe designs in the SCORE Study, which evaluated intravitreal triamcinolone acetonide injection(s) for vision loss secondary to macular edema associated with central or branch retinal vein occlusion. Injections were given at baseline and 4-month intervals, based on treatment assignment and study-defined retreatment criteria. Because intravitreal SO was observed following injections in some participants, investigators were instructed, on September 22, 2006, to look for intravitreal SO at all study visits. On November 1, 2007, the luer cone syringe design replaced the staked-on syringe design.

Results

A total of 464 participants received a total of 1,205 injections between November 4, 2004 and February 28, 2009. Intravitreal SO was noted in 141 of 319 participants (44%) exposed only to staked-on syringes, 11 of 87 (13%) exposed to both syringe designs, and 0 of 58 exposed only to luer cone syringes (P < .0001). Among participants with first injections after September 22, 2006, intravitreal SO was noted in 65 of 114 (57%) injected only with staked-on syringes compared with 0 of 58 injected only with luer cone syringes. Differential follow-up is unlikely to explain these results.

Conclusion

In the SCORE Study, luer cone syringe design is associated with a lower frequency of intravitreal SO droplet occurrence compared with the staked-on syringe design, likely attributable to increased residual space in the needle hub with the luer cone design.

SUBMITTER: Scott IU

PROVIDER: S-EPMC2780008 | biostudies-literature | 2009 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design.

Scott Ingrid U IU Oden Neal L NL VanVeldhuisen Paul C PC Ip Michael S MS Blodi Barbara A BA Antoszyk Andrew N AN

American journal of ophthalmology 20090811 5

<h4>Purpose</h4>To evaluate the incidence of intravitreal silicone oil (SO) droplets associated with intravitreal injections using a staked-on vs luer cone syringe design in the SCORE (Standard Care vs COrticosteroid in REtinal Vein Occlusion) Study.<h4>Design</h4>Prospective, randomized, phase III clinical trial.<h4>Methods</h4>The incidence of intravitreal SO was compared among participants exposed to the staked-on syringe design, the luer cone syringe design, or both of the syringe designs in ...[more]

PMID: 19674727

Similar Datasets

Project description:ImportanceThe Standard of Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study showed that intravitreal triamcinolone acetonide (IVTA) is effective at reducing macular edema and improving visual acuity in participants with retinal vein occlusion. Secondary analysis of the incidence, risk factors, and timing of intraocular pressure (IOP) elevation occurring after IVTA provides guidance for clinical decision making and management of patients treated with IVTA.ObjectiveTo investigate the incidence, risk factors, and time course of IOP elevation in participants in the SCORE Study.Design, setting, and participantsSecondary analysis conducted from August through December 2014 of a prospective, randomized clinical trial featuring an evaluable population conducted at 75 clinical sites. Six hundred eighty-two patients with macular edema secondary to retinal vein occlusion were enrolled in the study. The SCORE Study enrollment period ran from November 4, 2004, to February 29, 2008, with participant follow-up ending February 28, 2009.InterventionsStudy participants were randomized to standard of care, 1 mg of IVTA, or 4 mg of IVTA therapy and followed up for a mean (SD) of 24.7 (10.3) months.Main outcomes and measuresIntraocular pressure elevation greater than 10 mm Hg from baseline.ResultsKaplan-Meier incidences of IOP elevation greater than 10 mm Hg from baseline at 36 months were 0.02 (95% CI, 0.01-0.06), 0.09 (95% CI, 0.05-0.14), and 0.45 (95% CI, 0.38-0.53) in the standard of care, 1-mg IVTA, and 4-mg IVTA groups, respectively. The rates of IOP-related events were higher for the 4-mg IVTA group compared with the other groups (P ≤ .001 for main outcome measure). Younger age, 4-mg IVTA vs 1-mg IVTA treatment, and higher baseline IOP were found to confer greater risk for IOP-related events (P < .05 for all). The median number of days from time of first injection to IOP elevation greater than 10 mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively.Conclusions and relevanceIntravitreal triamcinolone acetonide injection therapy, in particular the 4-mg dose, is associated with an increased risk for IOP elevation. The risk factors for an IOP-related event include higher treatment dose, younger age, and higher baseline IOP. Intraocular pressure-related events may take several months from the time of first IVTA injection to occur. Clinicians should be mindful of these risk factors when assessing the risks and benefits of IVTA therapy and also of the need for long-term follow-up of participants at risk for this complication.Trial registrationclinicaltrials.gov Identifier: NCT00105027.

Project description:PURPOSE:To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI). DESIGN:Multicenter, randomized clinical trial. PARTICIPANTS:Patients with uveitic ME. METHODS:Patients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes. MAIN OUTCOME MEASURES:The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ?20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks. RESULTS:All treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ?24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups. CONCLUSIONS:Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

Project description:Wetting plays a major role in the close interactions between liquids and solid surfaces, which can be tailored by modifying the chemistry as well as the structures of the surfaces' outermost layer. Several methodologies, such as chemical vapor deposition, physical vapor deposition, electroplating, and chemical reactions, among others, have been adopted for the alteration/modification of such interactions suitable for various applications. However, the fabrication of low-contact line-pinning hydrophobic surfaces via simple and easy methods remains an open challenge. In this work, we exploit one-step and multiple-step silicone oil (5-100 cSt) grafting on smooth silicon substrates (although the technique is suitable for other substrates), looking closely at the effect of viscosity as well as the volume and layers (one to five) of oil grafted as a function of the deposition method. Remarkably, the optimization of grafting of silicone oil fabrication results in non-wetting surfaces with extremely low contact angle hysteresis (CAH) below 1° and high contact angles (CAs) of ∼108° after a single grafting step, which is an order of magnitude smaller than the reported values of previous works on silicone oil-grafted surfaces. Moreover, the different droplet-surface interactions and pinning behavior can additionally be tailored to the specific application with CAH ranging from 1 to 20° and sliding angles between 1.5 and 60° (for droplet volumes of 3 μL), depending on the fabrication parameters adopted. In terms of roughness, all the samples (independent of the grafting parameters) showed small changes in the root-mean-square roughness below 20 nm. Lastly, stability analysis of the grafting method reported here under various conditions shows that the coating is quite stable under mechanical vibrations (bath ultrasonication) and in a chemical environment (ultrasonication in a bath of ethanol) but loses its low-pinning characteristics when exposed to saturated steam at T ∼ 99 °C. The findings presented here provide a basis for selecting the most appropriate and suitable method and parameters for silicone oil grafting aimed at low pinning and low hysteresis surfaces for specific applications.

Project description:Purpose:To investigate the characteristics of silicone oil (SO) emulsification after vitrectomy for rhegmatogenous retinal detachment and their possible correlations with clinical factors. Methods:The first 2?mL of washing out fluid after SO removal was collected, and used for the measurement of the size and number of SO droplets using a Multisizer® 3 Coulter counter (Beckman Coulter, USA). The correlations between SO droplets and clinical factors were analyzed. Results:A total of 38 patients (23 males, 15 females) who underwent primary PPV with SO injection for RRD and whose retina stayed attached for ?3 months after SO removal were included in the study. The average number of oil droplets was 1.96?×?106?±?3.95?×?106/mL (range 0.17?×?106 to 21.71?×?106/ml), and 80.8% (range 64.23%-99.07%) of the droplets were 1-2??m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all P > 0.05). When the emulsified SO droplets were divided into groups by their diameter, multiple linear regression revealed that age was negatively correlated with the numbers of 5-7-?m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all ?m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all P > 0.05). When the emulsified SO droplets were divided into groups by their diameter, multiple linear regression revealed that age was negatively correlated with the numbers of 5-7-?m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all ?m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all P > 0.05). When the emulsified SO droplets were divided into groups by their diameter, multiple linear regression revealed that age was negatively correlated with the numbers of 5-7. Conclusion:Using a Multisizer® Coulter counter, we successfully determined the number and size of SO droplets after emulsification. We found that the number of 5-12-?m-diameter droplets was higher in younger-age patients and was higher in patients using antiglaucoma eyedrops.?m in diameter. The total number of emulsified SO droplets was not correlated with any clinical factor (all.

Dataset Information

SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design.

Purpose

Design

Methods

Results

Conclusion

Publications

SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets