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Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.

ABSTRACT: Purpose:This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. Methods:Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (needle length), and demographics, and ocular characteristics. Results:In the user survey, 84% (31/37) of physician-investigators did not perceive the SC injections to be meaningfully more challenging than other ocular injections. For the correlation analysis, the 900 µm needle was used for 71% (412/581) of baseline injections, and switching to the longer needle occured in the remaining 29% of baseline injections. No statistical correlations were found between needle lengths and age, race, disorder, refraction, visual acuity, intraocular pressure, retinal central subfield thickness, or lens status. Patient gender and needle length were statistically associated, with 76% (210/275) versus 66% (202/306) of injections administered with 900 µm needles for female and male gender, respectively. Injection quadrant correlated to needle length with 78% (214/275) of superotemporal quadrant injections administered with 900 µm needles, compared with 65% (73/113) of inferotemporal quadrant injections. Conclusions:Both the user survey and the correlation analysis demonstrated that SC injection is well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. Translational Relevance:These results, along with the presented ex-vivo endoscopic imaging, suggest that SC injection could be readily adopted in clinical practice for targeted compartmentalized delivery of ocular therapeutics.

SUBMITTER: Wan CR

PROVIDER: S-EPMC7585395 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.

Wan Chen-Rei CR Kapik Barry B Wykoff Charles C CC Henry Christopher R CR Barakat Mark R MR Shah Milan M Andino Rafael V RV Ciulla Thomas A TA

Translational vision science & technology 20201022 11

<h4>Purpose</h4>This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space.<h4>Methods</h4>Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (need ...[more]

PMID: 33150052

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Project description:ImportanceIn-office suprachoroidal viscopexy (SCVEXY) is a minimally invasive technique for rhegmatogenous retinal detachment (RRD) repair that can be performed with no incision, no tamponade agent, and no positioning requirements. This technique has the potential to be a step forward in the armamentarium to treat RRDs.ObjectiveTo describe in-office SCVEXY for RRD repair.Design, setting, and participantIn this single-case report with short follow-up, a man in his 50s with pseudophakia and recent visual loss presented to St Michael's Hospital, Unity Health Toronto, with a fovea-off RRD in the right eye, extending from 6 to 10 o'clock, with no visible causative retinal break.ExposureInjection of suprachoroidal sodium hyaluronate, 1%, in the region of the suspected break, using a 30-gauge needle with a custom-made guard that exposed only 1 mm of the needle.Main outcome and measuresAbility to perform in-office SCVEXY and to obtain a visible choroidal indentation.ResultsAfter the procedure, a dome-shaped choroidal convexity was present in the superior temporal area. The patient achieved macular reattachment in less than 24 hours with no postoperative abnormalities, such as outer retinal folds, residual subfoveal fluid, or retinal displacement, with rapid recovery of the outer retinal bands on optical coherence tomography. The optical coherence tomography scans acquired in the area of the choroidal convexity demonstrated the location of the viscoelastic material in the suprachoroidal space. Laser retinopexy was applied in the suspected region of the retinal tear, and the patient was able to resume normal activity immediately after the procedure with no restrictions.Conclusions and relevanceSuprachoroidal viscopexy is feasible as an in-office technique to create a temporary choroidal buckle for RRD repair. It is a minimally invasive procedure with the potential to maximize anatomical outcomes of integrity and postoperative functional outcomes in RRD because its mechanism of action does not require drainage of subretinal fluid or intraocular gas tamponade. Nevertheless, this was a single-case report with short follow-up, which limits the ability to determine the procedure's benefits, potential adverse events, failure rates, and best-case selection. Further work is required to refine the procedure and assess its efficacy and safety.

Dataset Information

Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.

Publications

Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.

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