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Intraoperative optical coherence tomographic findings in patients undergoing subretinal gene therapy surgery.

ABSTRACT: Background:To analyze intraoperative OCT (iOCT) findings during subretinal gene therapy. Methods:A single-center, retrospective, observational, case series study of twenty one eyes submitted to subretinal gene therapy. Intrasurgical high definition videos were included for analyzes. Cases with absence of iOCT video or unsuccessful bleb creation were excluded. Sharp needle tip (SNT) or blunted needle tip (BNT) and their interaction with neurosensory retina were evaluated. Presence of subretinal air bubbles, visible opened retinotomy, and medication reflux were also correlated and analyzed. Results:Nineteen of twenty-one eyes were included. Of the two excluded eyes, subretinal bleb creation was unsuccessful in one and technical issues prevented OCT image acquisition in the other. Immediately before subretinal injection, needle indention/penetration of the neurosensory retina with temporary indentation of the RPE/choroid was evident in 16 (84%) of the 19 eyes. Complete RPE/choroid indentation was needed with BNT use compared to SNT (p?=?0.0114). An open retinotomy was identified in 14 (74%) of 19 eyes at the conclusion of bleb injection and was more commonly associated with SNT (p?=?0.0108). Conclusions:iOCT provides valuable real-time feedback of cross-sectional retinal anatomy during subretinal gene therapy surgeries. The type of needle tip and its use during the gene therapy procedure seems to influence in the bleb creation and presence of visible open retinotomy. Further studies of iOCT findings during gene therapy delivery procedures are likely to help refine the surgical technique.

SUBMITTER: Vasconcelos HM

PROVIDER: S-EPMC7193395 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Intraoperative optical coherence tomographic findings in patients undergoing subretinal gene therapy surgery.

Vasconcelos Huber M HM Lujan Brandon J BJ Pennesi Mark E ME Yang Paul P Lauer Andreas K AK

International journal of retina and vitreous 20200501

<h4>Background</h4>To analyze intraoperative OCT (iOCT) findings during subretinal gene therapy.<h4>Methods</h4>A single-center, retrospective, observational, case series study of twenty one eyes submitted to subretinal gene therapy. Intrasurgical high definition videos were included for analyzes. Cases with absence of iOCT video or unsuccessful bleb creation were excluded. Sharp needle tip (SNT) or blunted needle tip (BNT) and their interaction with neurosensory retina were evaluated. Presence ...[more]

PMID: 32377379

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Project description:PurposeWe report a case of old submacular hemorrhage (SMH) due to polypoidal choroidal vasculopathy (PCV). Subretinal endoscopic surgery (SES) was performed, which improved visual function. In addition, we show the intraoperative findings of subretinal aberrant PCV vessels as seen under endoscopic observation, which cannot be observed by microscopic surgery.ObservationsA 71-year-old Japanese man presented with an old dehemoglobinized SMH due to PCV in his left eye. At the time of presentation, three weeks had already passed after the onset of the patient's symptoms, and the best-corrected visual acuity (BCVA) was 20/200. SES was performed to remove the SMH and treat the subretinal PCV lesions. After creating retinal detachment using a 38-gauge cannula, three subretinal 25-gauge trocars were inserted from the sclera to the subretinal space. Then, SES was performed under ophthalmic endoscopic observation with continued subretinal irrigation for maintaining the retinal detachment. After removal of the SMH, subretinal polyp-shaped nodular vascular lesions (polyps) and a branching vascular network, which is located inside the retinal pigmented epithelium, were identified. The sites that presumably originated from the aberrant vessels of the PCV and the associated polyps were coagulated using endodiathermy. After the subretinal procedure, the retina was flattened with fluid/air exchange, and silicone oil (SO) was injected into the vitreous cavity. The SMH completely disappeared after surgery. Although at one-month follow-up BCVA (20/250) was slightly worse than that before surgery, there was an improvement in postoperative retinal sensitivity in the macula compared to that before surgery. At the three-month follow-up, the SO was removed. The BCVA was 20/200 one month after SO removal. No postoperative complications occurred. Additional treatment was not required, including anti-vascular endothelial growth factor therapy, for PCV progression or SMH recurrence in the left eye till the final visit two years after surgery.Conclusion and importanceSES could effectively remove the old SMH, and the activity of PCV was suppressed by intraoperative subretinal coagulation. The retinal sensitivity of the macula improved after the SES. In addition, we observed subretinal polyps and a branching vascular network located internal to the retinal pigmented epithelium under intraoperative subretinal endoscopic observation. SES is a good surgical option for the removal of old SMH or treatment of subretinal lesions.

Project description:ImportanceBiomarker testing for asymptomatic, preclinical Alzheimer disease (AD) is invasive and expensive. Optical coherence tomographic angiography (OCTA) is a noninvasive technique that allows analysis of retinal and microvascular anatomy, which is altered in early-stage AD.ObjectiveTo determine whether OCTA can detect early retinal alterations in cognitively normal study participants with preclinical AD diagnosed by criterion standard biomarker testing.Design, setting, and participantsThis case-control study included 32 participants recruited from the Charles F. and Joanne Knight Alzheimer Disease Research Center, Washington University in St Louis, St Louis, Missouri. Results of extensive neuropsychometric testing determined that all participants were cognitively normal. Participants underwent positron emission tomography and/or cerebral spinal fluid testing to determine biomarker status. Individuals with prior ophthalmic disease, media opacity, diabetes, or uncontrolled hypertension were excluded. Data were collected from July 1, 2016, through September 30, 2017, and analyzed from July 30, 2016, through December 31, 2017.Main outcomes and measuresAutomated measurements of retinal nerve fiber layer thickness, ganglion cell layer thickness, inner and outer foveal thickness, vascular density, macular volume, and foveal avascular zone were collected using an OCTA system from both eyes of all participants. Separate model III analyses of covariance were used to analyze individual data outcome.ResultsFifty-eight eyes from 30 participants (53% female; mean [SD] age, 74.5 [5.6] years; age range, 62-92 years) were included in the analysis. One participant was African American and 29 were white. Fourteen participants had biomarkers positive for AD and thus a diagnosis of preclinical AD (mean [SD] age, 73.5 [4.7] years); 16 without biomarkers served as a control group (mean [SD] age, 75.4 [6.6] years). The foveal avascular zone was increased in the biomarker-positive group compared with controls (mean [SD], 0.364 [0.095] vs 0.275 [0.060] mm2; P = .002). Mean (SD) inner foveal thickness was decreased in the biomarker-positive group (66.0 [9.9] vs 75.4 [10.6] μm; P = .03).Conclusions and relevanceThis study suggests that cognitively healthy individuals with preclinical AD have retinal microvascular abnormalities in addition to architectural alterations and that these changes occur at earlier stages of AD than has previously been demonstrated. Longitudinal studies in larger cohorts are needed to determine whether this finding has value in identifying preclinical AD.

Project description:ImportanceArtifacts can affect optical coherence tomographic angiography (OCTA) images and may be associated with misinterpretation of OCT scans in both clinical trials and clinical settings.ObjectivesTo identify the prevalence and type of artifacts in OCTA images associated with quantitative output and to analyze the role of proprietary quality indices in establishing image reliability.Design, setting, and participantsThis cross-sectional study evaluated baseline OCTA images acquired in multicenter clinical trials and submitted to the Fundus Photograph Reading Center in Madison, Wisconsin, between January 1, 2016, and December 31, 2018. Images were captured using the 3 mm × 3 mm and/or 6 mm × 6 mm scan protocol with commercially available OCTA systems. Artifacts, including decentration, segmentation error, movement, blink, refraction shift, defocus, shadow, Z offset, tilt, and projection, were given a severity grade based on involvement of cross-sectional OCT and area of OCT grid affected.Main outcomes and measuresPrevalence and severity of OCTA artifacts and area under the receiver operating characteristic curve (AUC) of quality indices with image reliability.ResultsA total of 406 OCTA images from 234 eyes were included in this study, of which 221 (54.4%) were 6 mm × 6 mm scans and 185 (45.6%) were 3 mm × 3 mm scans. At least 1 artifact was documented in 395 images (97.3%). Severe artifacts associated with the reliability of quantitative outputs were found in 217 images (53.5%). Shadow (26.9% [109 images]), defocus (20.9% [85 images]), and movement (16.0% [65 images]) were the 3 most prevalent artifacts. Prevalence of artifacts did not vary with the imaging system used or with the scan protocol; however, the type of artifacts varied. Commercially recommended quality index thresholds had an AUC of 0.80 to 0.83, sensitivity of 97% to 99%, and specificity of 37% to 41% for reliable images.Conclusions and relevanceFindings from this study suggest that artifacts associated with quantitative outputs on commercially available OCTA devices are highly prevalent and that identifying common artifacts may require correlation with the angiogram and cross-sectional OCT scans. Knowledge of these artifacts and their implications for OCTA indices appears to be warranted for more accurate interpretation of OCTA images.

Project description:PurposeTranscorneal electrical stimulation (TES) is a novel treatment approach for patients with retinitis pigmentosa (RP). The aim of our study was to observe changes in optical coherence tomography angiography (OCTA) that would be attributed to TES treatment.MethodsA total of 73 eyes were included: 43 eyes of 22 subjects (11 ♀, 11 ♂) suffering from RP were examined at baseline (BL), after first stimulation (TS), 1 week (1W), and 6 months (6M) after treatment initiation and were compared with 30 control eyes of 15 subjects (8 ♀, 7 ♂). TES was performed simultaneously on both eyes for 30 min weekly. OCTA scans of 9 × 15 mm were recorded with a PLEX Elite 9000 swept-source OCTA device (Carl Zeiss Meditec AG, Jena). Vascular density metrics such as perfusion density (PD) and vessel density (VD) were calculated automatically for the macular area by using standardised extended early treatment diabetic retinopathy study (ETDRS) grids centred around the fovea. In addition, the capillary perfusion density (CPD) and the capillary flux index (CFI) of the peripapillary nerve fibre layer microvasculature in all four quadrants of an annulus centred at the optic disc were measured. All parameters were determined over all retinal layers and separately for the superficial (SCP) and deep capillary plexus (DCP). ANOVA-based linear mixed-effects models were calculated with SPSS®.ResultsThroughout the course of TES treatment, the macular VD and PD of all retinal layers in all subsections showed a slight decrement without reaching statistical significance, also when analysed separately in the SCP and DCP (p > 0.08). In analogy, the average CPD and CFI also presented with a slight decrement (p > 0.20). However, when compared with controls, most OCTA parameters showed a significant decrement (p < 0.05). When analysed systematically in all subsections of the extended ETDRS grid, the temporal macular subsections within the outer ring (radius 1.5-3 mm) and also of the peripheral C1, C2, and C3 rings (radius 3-7.5 mm) showed lower VD and PD values when compared with the other subsections (p < 0.05).ConclusionVascular density metrics in the macular region and the peripapillary microvasculature appear to remain unaffected by continuous TES treatment within a period of 6 months.

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Intraoperative optical coherence tomographic findings in patients undergoing subretinal gene therapy surgery.

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Intraoperative optical coherence tomographic findings in patients undergoing subretinal gene therapy surgery.

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