The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) ...for the management of primary RRD.
Prospective, randomized controlled trial.
Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina.
Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively.
The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success.
One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001).
Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfilling Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.
IMPORTANCE: Variability in response to anti–vascular endothelial growth factor (VEGF) treatment in diabetic macular edema (DME) remains a significant clinical challenge. Biomarkers could help ...anticipate responses to anti-VEGF therapy. OBJECTIVES: To investigate aqueous humor cytokine level changes in response to intravitreal ranibizumab therapy for the management of DME, and to determine the association between baseline aqueous levels and anatomic response. DESIGN, SETTING, AND PARTICIPANTS: In this prospective multicenter cohort study, 49 participants with diabetes mellitus complicated by center-involving DME, with a central subfield thickness of 310 μm or greater on spectral-domain optical coherence tomography (SD-OCT), were recruited from December 22, 2011, to June 13, 2013 and statistical analysis were performed from March 1, 2017, to June 1, 2017. A total of 48 participants proceeded to follow-up. INTERVENTIONS: Participants received monthly injections of ranibizumab, 0.5 mg, for 3 months. Aqueous fluid for cytokine analysis was obtained at baseline and repeated at the 2-month visit. Multiplex immunoassay was carried out in duplicate for VEGF, placental growth factor, transforming growth factor beta 2, intercellular adhesion molecule 1 (ICAM-1), interleukin 6 (IL-6), IL-8, IL-10, vascular intercellular adhesion molecule, and monocyte chemoattractant protein 1. MAIN OUTCOMES AND MEASURES: Baseline and 2-month change in aqueous cytokine levels, 3-month change in SD-OCT central subfield thickness and macular volume (MV), and the statistical association between baseline aqueous cytokine levels and these measures of anatomic response to ranibizumab in center-involving DME. RESULTS: Among the 48 participants, the mean (SD) age was 61.9 (7.1) years and 36 participants (75.0%) were men. The following cytokines were lower at month 2 vs baseline: ICAM-1 (median change, −190.88; interquartile range IQR, −634.20 to −26.54; P < .001), VEGF (median change, −639.45; IQR, −1040.61 to −502.61; P < .001), placental growth factor (median change, −1.31; IQR, −5.99 to −0.01; P < .001), IL-6 (median change, −38.61; IQR, −166.72 to −2.80; P < .001), and monocyte chemoattractant protein 1 (median change, −90.13; IQR, −382.74 to 109.47; P = .01). When controlling for age, foveal avascular zone size, and severity of retinopathy, multiple linear regression determined that increasing baseline aqueous ICAM-1 was associated with a favorable anatomic response, in terms of reduced SD-OCT MV at 3 months (every additional 100 pg/mL of baseline ICAM-1 was associated with a reduction of 0.0379 mm3; P = .01). Conversely, increasing baseline aqueous VEGF was associated with a less favorable SD-OCT MV response at 3 months (every additional 100 pg/mL of baseline VEGF was associated with an increase of 0.0731 mm3; P = .02) and was associated with lower odds of being a central subfield thickness responder (odds ratio, 0.868; 95% CI, 0.755-0.998). CONCLUSIONS AND RELEVANCE: Elevated aqueous ICAM-1 and reduced VEGF levels at baseline are associated with a favorable anatomic response to ranibizumab in DME, although there is not always direct correlation between anatomic and visual acuity response.
The management of rhegmatogenous retinal detachment has rapidly evolved over recent decades. A range of surgical techniques exist, all of which can achieve retinal reattachment in most cases. In ...recent years there have also been vast technical advances in retinal imaging that have introduced novel ways of visualizing and studying the retinal macro and microstructural anatomy following retinal detachment repair.
Recent clinical trial data demonstrates that functional and patient-reported outcomes of retinal reattachment differ with surgical technique, accompanied by differences in anatomic biomarkers of retinal recovery or ‘integrity’. We discuss recent insights into the physiology of retinal reattachment gleaned from multimodal imaging, which shed light on the pathophysiology of various post-operative anatomic abnormalities. The ideal scenario is to achieve retinal reattachment as soon as possible, without retinal displacement, outer retinal folds or discontinuity of the external limiting membrane, ellipsoid zone and interdigitation zone, with an intact foveal bulge. To this end, we present an in-depth contemporary account of current concepts and mechanisms involved during retinal reattachment surgery, supported by clinical data and mathematical modelling, awareness of which can help the vitreoretinal surgeon achieve better post-operative outcomes.
In this review we substantiate the case for a paradigm shift in rhegmatogenous retinal detachment repair; beyond the emphasis on single-operation reattachment rates, and instead striving to maximize functional outcomes using minimally invasive techniques. This can only be achieved if vitreoretinal surgeons embrace all of the available techniques, with individualized selection of surgical approach and the resolute goal of optimizing the ‘integrity’ of retinal reattachment.
•Functional outcomes vary with surgical technique for retinal detachment repair.•Advances in imaging have enabled assessment of the integrity of retinal reattachment.•Structural recovery of photoreceptors differs with variations in surgical technique.•Risk of retinal displacement and outer retinal folds vary with surgical technique.•Retinal pigment epithelium pump based procedures offer the best outcomes.
Retinal displacement following rhegmatogenous retinal detachment (RRD) repair is an important consideration when assessing the integrity of reattachment, with potential implications on functional ...outcomes. There are limited data comparing various surgical techniques. We conducted a review of retinal displacement following RRD repair through October 2021, finding 21 studies encompassing 1,258 unique eyes. Outcome measures included the frequency of retinal displacement, visual acuity, metamorphopsia, and displacement direction. A meta-analysis was performed with data reported as risk ratios (RR) or mean difference and 95% confidence intervals. Retinal displacement was found in 35 ± 20% of RRD repairs. Scleral buckle (SB) without tamponade had the lowest rate of retinal displacement, followed by pneumatic retinopexy (PnR) and finally pars plana vitrectomy (PPV) (RR in PPV vs SB: 9.60 2.01–45.95, P = 0.005). Silicone oil may reduce risk of displacement following PPV compared to gas (RR in gas vs SO: 2.16 1.22–3.83, P = 0.009), as may immediate face-down positioning for 2 hours. Retinal displacement following PPV occurred in the downward direction in 92 ± 14% of cases and does not appear to significantly impact visual acuity (0.05 -0.21 to 0.31, P = 0.70), although it may increase distortion. SB, PnR, PPV with silicone oil, and immediate face-down positioning are likely associated with less retinal displacement. Additional prospective studies are required to increase the certainty of these findings.
IMPORTANCE: Retinal displacement following rhegmatogenous retinal detachment repair may have consequences for visual function. It is important to know whether surgical technique is associated with ...risk of displacement. OBJECTIVE: To compare retinal displacement following rhegmatogenous retinal detachment repair with pneumatic retinopexy (PR) vs pars plana vitrectomy (PPV). INTERVENTIONS OR EXPOSURES: Fundus autofluorescence images were assessed by graders masked to surgical technique. DESIGN, SETTING, AND PARTICIPANTS: A multicenter retrospective consecutive case series in Canada and the UK. A total of 238 patients (238 eyes) with rhegmatogenous retinal detachments treated with PR or PPV who underwent fundus autofluorescence imaging from November 11, 2017, to March 22, 2019, were included. MAIN OUTCOMES AND MEASURES: Proportion of patients with retinal displacement detected by retinal vessel printings on fundus autofluorescence imaging in PR vs PPV. RESULTS: Of the 238 patients included in the study, 144 were men (60.5%) and 94 were women (39.5%); mean (SD) age was 62.0 (11.0) years. Of the 238 eyes included in this study, 114 underwent PR (47.9%) and 124 underwent PPV (52.1%) as the final procedure to achieve reattachment. Median time from surgical procedure to fundus autofluorescence imaging was 3 months (interquartile range, 1-5 months). Baseline characteristics in both groups were similar. The proportion of eyes with retinal vessel printing on fundus autofluorescence was 7.0% for PR (8 of 114) and 44.4% for PPV (55 of 124) (37.4% difference; 95% CI, 27.4%-47.3%; P < .001). Analysis based on the initial procedure found that 42.4% (42 of 99) of the eyes in the PPV group vs 15.1% (21 of 139) of the eyes in the PR group (including 13 PR failures with subsequent PPV) had displacement (27.3% difference; 95% CI, 15.9%-38.7%; P < .001). Among eyes with displacement in the macula, the mean (SD) displacement was 0.137 (0.086) mm (n = 6) for PR vs 0.297 (0.283) mm (n = 52) for PPV (0.160-mm difference; 95% CI, 0.057-0.263 mm; P = .006). Mean postoperative logMAR visual acuity was 0.31 (0.32) (n = 134) (Snellen equivalent 20/40) in eyes that initially underwent PR and 0.56 (0.42) (n = 84) (Snellen equivalent 20/72) in eyes that had PPV (−0.25 difference; 95% CI, −0.14 to −0.35; P < .001). Among eyes with displacement, mean postoperative logMAR visual acuity was 0.42 (0.42) (n = 20) (Snellen equivalent 20/52) in those that initially underwent PR and 0.66 (0.47) (n = 33) (Snellen equivalent 20/91) in those that initially underwent PPV (−0.24 difference; 95% CI, −0.48 to 0.01; P = .07). CONCLUSIONS AND RELEVANCE: These findings suggest that retinal displacement occurs more frequently and is more severe with PPV vs PR when considering the initial and final procedure used to achieve retinal reattachment. Recognizing the importance of anatomic integrity by assessing retinal displacement following reattachment may lead to refinements in vitreoretinal surgery techniques.
Pneumatic retinopexy (PnR) is associated with superior visual acuity and reduced vertical metamorphopsia compared with pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD). ...It is important to determine postoperative photoreceptor integrity with both surgical techniques.
To compare photoreceptor integrity on spectral domain-optical coherence tomography (SD-OCT) between PnR and PPV at 12 months postoperatively.
Post hoc analysis of the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada. Primary RRDs with specific criteria were included. Data were analyzed between April and August 2020.
Randomization to PnR vs PPV stratified by macular status.
Difference in proportion of patients with discontinuity of the ellipsoid zone (EZ) and external limiting membrane (ELM) between groups assessed independently by 2 masked graders at an external masked image reading center.
A total of 150 participants completed the 12-month follow-up visit. A total of 145 patients (72 PPV and 73 PnR) had gradable spectral-domain optical coherence tomography at 12 months. Analysis of the central 3-mm (foveal) scans found that 24% (n = 17 of 72) vs 7% (n = 5 of 73) displayed EZ discontinuity (difference, 17%; odds ratio OR, 4.204; 95% CI, 1.458-12.116; P = .005) and 20% (n = 14 of 71) vs 6% (n = 4 of 73) displayed ELM discontinuity (difference, 14%; OR, 4.237; 95% CI, 1.321-13.587; P = .01) in the PPV and PnR groups, respectively. Analysis of the 6-mm (foveal and nonfoveal) scans revealed that EZ and ELM discontinuity was greater in the PPV vs PnR groups (EZ, 32% n = 23 of 72 vs 11% n = 8 of 73; difference, 21%; OR, 3.814; 95% CI, 1.573-9.249; P = .002; ELM, 32% n = 23 of 71 vs 18% n = 13 of 73; difference, 14%; OR, 2.211; 95% CI, 1.015-4.819; P = .04).
Discontinuity of the EZ and ELM was more common at 12 months postoperatively following PPV vs PnR for RRD repair. The findings of this post hoc analysis suggest that less discontinuity of the EZ and ELM may provide an anatomic basis for the previously reported superior functional outcomes with PnR, although the analysis does not prove a cause-and-effect relationship.
ClinicalTrials.gov Identifier: NCT01639209.
IMPORTANCE: Pneumatic retinopexy (PnR) is associated with superior visual acuity and reduced vertical metamorphopsia compared with pars plana vitrectomy (PPV) for primary rhegmatogenous retinal ...detachment (RRD). It is important to determine postoperative photoreceptor integrity with both surgical techniques. OBJECTIVE: To compare photoreceptor integrity on spectral domain-optical coherence tomography (SD-OCT) between PnR and PPV at 12 months postoperatively. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) conducted between August 2012 and May 2017 at St Michael’s Hospital, Toronto, Ontario, Canada. Primary RRDs with specific criteria were included. Data were analyzed between April and August 2020. INTERVENTION: Randomization to PnR vs PPV stratified by macular status. MAIN OUTCOMES AND MEASURES: Difference in proportion of patients with discontinuity of the ellipsoid zone (EZ) and external limiting membrane (ELM) between groups assessed independently by 2 masked graders at an external masked image reading center. RESULTS: A total of 150 participants completed the 12-month follow-up visit. A total of 145 patients (72 PPV and 73 PnR) had gradable spectral-domain optical coherence tomography at 12 months. Analysis of the central 3-mm (foveal) scans found that 24% (n = 17 of 72) vs 7% (n = 5 of 73) displayed EZ discontinuity (difference, 17%; odds ratio OR, 4.204; 95% CI, 1.458-12.116; P = .005) and 20% (n = 14 of 71) vs 6% (n = 4 of 73) displayed ELM discontinuity (difference, 14%; OR, 4.237; 95% CI, 1.321-13.587; P = .01) in the PPV and PnR groups, respectively. Analysis of the 6-mm (foveal and nonfoveal) scans revealed that EZ and ELM discontinuity was greater in the PPV vs PnR groups (EZ, 32% n = 23 of 72 vs 11% n = 8 of 73; difference, 21%; OR, 3.814; 95% CI, 1.573-9.249; P = .002; ELM, 32% n = 23 of 71 vs 18% n = 13 of 73; difference, 14%; OR, 2.211; 95% CI, 1.015-4.819; P = .04). CONCLUSIONS AND RELEVANCE: Discontinuity of the EZ and ELM was more common at 12 months postoperatively following PPV vs PnR for RRD repair. The findings of this post hoc analysis suggest that less discontinuity of the EZ and ELM may provide an anatomic basis for the previously reported superior functional outcomes with PnR, although the analysis does not prove a cause-and-effect relationship. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01639209
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