Randomized Controlled Trial

Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration.

Authors: Pierre-Henry Gabrielle, Marie-Noëlle Delyfer, Agnès Glacet-Bernard...

PURPOSE

To compare the efficacy and the safety of submacular hemorrhage (SMH) management using either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD) with tissue plasminogen activator (tPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm.

DESIGN

Randomized, open-label, multicenter superiority study.

PARTICIPANTS

Ninety patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older with recent SMH (≤ 14 days) of more than 2 optic disc areas and predominantly overlying the retinal pigment epithelium.

METHODS

Patients were assigned randomly to surgery (PPV, subretinal tPA [maximum, 0.5 ml/50 μg], and 20% sulfur hexafluoride [SF] tamponade) or PD (0.05 ml intravitreal tPA [50 μg] and 0.3 ml intravitreal pure SF). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at months 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up.

MAIN OUTCOME MEASURES

The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at month 3. The secondary endpoints were mean VA change at month 6, 25-item National Eye Institute Visual Function Questionnaire composite score value at months 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up.

RESULTS

Of the 90 patients randomized, 78 patients (86.7%) completed the 3-month efficacy endpoint visit. The mean VA change from baseline to month 3 in the surgery group (+16.8 letters [95% confidence interval (CI), 8.7-24.9 letters]) was not significantly superior to that in the PD group (+16.4 letters [95% CI, 7.1-25.7 letters]; adjusted difference β, 1.9 [-11.0; 14.9]; P = 0.767). Both groups achieved similar secondary outcomes at month 6. No unexpected ocular safety concerns were observed in either group.

CONCLUSIONS

Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared with PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of VA without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments.

FINANCIAL DISCLOSURE(S)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Topics: Humans; Middle Aged; Infant, Newborn; Tissue Plasminogen Activator; Angiogenesis Inhibitors; Fibrinolytic Agents; Vascular Endothelial Growth Factor A; Ranibizumab; Retinal Hemorrhage; Macular Degeneration; Retinal Pigment Epithelium; Intravitreal Injections

PubMed: 37088447
DOI: 10.1016/j.ophtha.2023.04.014

Authors: Tingting Yang, Rongsheng Hu, Jiansu Chen...

Neonatal retinal hemorrhage (RH) is the most common ocular fundus disease among newborns. Early detection and timely intervention are vital for reducing the risk of visual impairment caused by RH. However, little is known about the prevalence, characteristics, and risk factors of RH in southern China. Full-term infants born in Qingyuan City during the first 10 days of each month in 2021 were included in this study. All infants underwent RetCam III retinal examinations. Detailed information on retinal hemorrhage, including involved eyes, bleeding severity, and affected area (extrafoveal macula, fovea, or optic disc), and clinical information on the neonates and their mothers was collected. The results showed that among the 1072 eligible neonates, 266 (24.8%) had neonatal retinal hemorrhage. Consistent bilateral retinal hemorrhage severity was observed in 83.2% of the cases. The prevalence of optic disc involved RH, extrafoveal macular involved RH and foveal involved RH were 23.7%, 81.2% and 2.63%, respectively. Multivariate logistic regression analysis showed that lower birth weight (OR, 0.63; 95% CI, 0.40-0.99; < 0.05) and vaginal delivery (OR, 20.6; 95% CI, 9.10-46.5; < 0.001) were risk factors of neonatal RH. The area under the ROC curve of vaginal delivery, combined with birth weight, as predictors of neonatal RH was 0.73, with 85.3% sensitivity and 23.9% specificity. The birth weight cutoff was 3460 g. Our results suggested that neonatal RH is common in full-term neonates in southern China. It usually has the same severity in both eyes and mostly involves the extrafoveal macular region. Vaginal delivery and low birth weight are risk factors for neonatal RH.

Topics: Infant; Female; Infant, Newborn; Humans; Retinal Hemorrhage; Birth Weight; Gestational Age; Prevalence; Risk Factors; Infant, Newborn, Diseases

PubMed: 36360805
DOI: 10.3390/ijerph192113927

Authors: Dhaivat Shah

BACKGROUND

: "Achoo" is the sound that is correlated with sneezing. A sneeze, in rare occasions, it can cause Valsalva retinopathy. Usually, small bleeding gets absorbed with time. But if the haemorrhage stays for a longer period of time, it can lead to de-hemoglobinization of blood which can cause damage to the photoreceptors. If such a damage occurs over the macula, it can cause irreversible visual loss. Hence, prompt and meticulous treatment is indicated in such cases. One such case is described here where a lady suffered from a sudden bout of sneezing and presented to us after a month later. A large sub-internal limiting membrane (ILM) bleed was noted over the macula. Hence a vitrectomy with ILM peeling with drainage of blood was advised. She recovered 20/40 visual acuity one month following surgery.

PURPOSE

This video emphasizes on diagnosis of sub-ILM hemorrhage and the technique in which the sub-ILM bleed can be drained in the modern era of microincision vitreoretinal surgeries.

SYNPOSIS

A key aspect in such cases is to distinguish sub-ILM from sub-hyaloid bleed. Subtle differentiating points on imaging are described in the video. In cases of sub-ILM hemorrhage, the most important surgical step after performing a core vitrectomy is a good posterior vitreous detachment (PVD) induction. After that, ILM peeling is carried out with the help of finesse loop and ILM peeling forceps. Using proportional vacuum and aspiration alternatively from the cutter, the hemorrhage is displaced and drained. This step can prevent damage to the underlying retinal tissue. After the macula hemorrhage is completely cleared, an air-fluid exchange is done.

HIGHLIGHTS

Teaching points include: 1. Diagnostic markers for sub-ILM hemorrhage; 2.The method of PVD induction in cases of Sub ILM hemorrhage; and 3.Technique of drainage of sub-ILM hemorrhage using proportional vacuum and aspiration function of the cutter.

VIDEO LINK

https://youtu.be/hBhfLDy9o-Y.

Topics: Basement Membrane; Epiretinal Membrane; Female; Humans; Macula Lutea; Retinal Hemorrhage; Retrospective Studies; Tomography, Optical Coherence; Visual Acuity; Vitrectomy

PubMed: 35086295
DOI: 10.4103/ijo.IJO_155_22

Authors: Hirawat Rajshri, Nagesha C Krishnappa, Unnatti Sharma...

Topics: Humans; Retina; Retinal Hemorrhage; Valsalva Maneuver

PubMed: 33674301
DOI: 10.1136/bcr-2020-240812

Authors: Astrid Meistad, Agata Frajdenberg

Topics: Fluorescein Angiography; Humans; Retinal Arterial Macroaneurysm; Retinal Diseases; Retinal Hemorrhage

PubMed: 33231403
DOI: 10.4045/tidsskr.20.0469

Authors: Shamik Dholakia, Yasmin Hashimi, Bhavneet Chawla...

Purtscher's retinopathy is a haemorrhagic and vaso-occlusive retinal vasculopathy, caused by microembolisation occluding retinal and choroidal arterioles. This leads to retinal haemorrhages and ischaemia. The usual cause is severe trauma. 1 However, a variety of conditions including acute pancreatitis, childbirth, long bone fracture, chest trauma and systemic inflammatory vasculitides may cause similar retinal presentations. 1-4 This highlights Purtscher's retinopathy as a clinically important differential diagnosis of visual loss. We present a case report of a 43-year-old man who was diagnosed with acute pancreatitis. While in hospital he developed sudden onset unilateral loss of vision. This case highlights the need to ensure prompt diagnosis and initiation of appropriate multidisciplinary management.

Topics: Adult; Alcoholism; Diagnosis, Differential; Diagnostic Imaging; Humans; Male; Pancreatitis; Retinal Hemorrhage

PubMed: 23470674
DOI: 10.1136/bcr-2013-008607

Authors: Sohan S Hayreh

PURPOSE

The aim of this experimental study was to investigate the pathogenesis of Terson syndrome (TS), which currently is controversial.

METHODS

The central retinal artery (in 39 orbits), posterior ciliary arteries (in 8 orbits), and central retinal vein (CRV in 21 orbits) were occluded in rhesus monkeys by exposing them to lateral orbitotomy. Fundus examination and fluorescein fundus angiography were performed before and immediately after cutting the vessels and serially thereafter during the follow-up period. The rationale of the experimental study design is discussed.

RESULTS

In eyes with central retinal artery occlusion, retinal hemorrhages were seen soon after the procedure in 7 eyes, and on follow-up in a total of 15 eyes. In posterior ciliary artery occlusion, retinal hemorrhages were seen soon after the procedure in one eye, and on follow-up in a total of three eyes. In eyes with CRV, all eyes had extensive scattered retinal hemorrhages.

CONCLUSION

The findings of this experimental study, and my basic, experimental, and comprehensive clinical studies on CRVO, suggest the following concept of the pathogenesis of TS: Compression of the CRV plays a crucial role in the development of TS. The CRV is compressed, as it lies in the subarachnoid space of the optic nerve sheath, by raised cerebrospinal fluid pressure and/or accumulated blood.

. THIS RESULTS IN RETINAL

venous stasis and raised venous pressure in the retinal veins, leading to venous engorgement, rupture of the retinal capillaries.

AND

retinal hemorrhages. The clinical importance of compression of the CRV and not occlusion of CRV in TS is that optic nerve sheath decompression by opening it and releasing the blood and raised cerebrospinal fluid (CSF) pressure, would result in immediate decompressing of the CRV in the subarachnoid space and restoration of normal circulation and prevent visual loss.

Topics: Humans; Retinal Hemorrhage; Retinal Vein; Retina; Retinal Artery; Ophthalmic Artery

PubMed: 36453300
DOI: 10.4103/ijo.IJO_1359_22

Review

Authors: John W Finnie, Peter C Blumbergs

BACKGROUND

Abusive head trauma (AHT), previously known as the shaken baby syndrome, is a severe and potentially fatal form of traumatic brain injury in infant children who have been shaken, and sometimes also sustained an additional head impact. The clinical and autopsy findings in AHT are not pathognomonic and, due to frequent obfuscation by perpetrators, the circumstances surrounding the alleged abuse are often unclear. The concept has evolved that the finding of the combination of subdural hemorrhage, brain injury, and retinal hemorrhages ("the triad") is the result of shaking of an infant ("shaken baby syndrome") and has led to the ongoing controversy whether shaking alone is able to generate sufficient force to produce these lesions.

OBJECTIVE

In an attempt to investigate whether shaking can engender this lesion triad, animal models have been developed in laboratory rodents and domestic animal species. This review assesses the utility of these animal models to reliably reproduce human AHT pathology and evaluate the effects of shaking on the immature brain.

RESULTS

Due largely to irreconcilable anatomic species differences between these animal brains and human infants, and a lack of resemblance of the experimental head shaking induced by mechanical devices to real-world human neurotrauma, no animal model has been able to reliably reproduce the full range of neuropathologic AHT changes.

CONCLUSION

Some animal models can simulate specific brain and ophthalmic lesions found in human AHT cases and provide useful information on their pathogenesis. Moreover, one animal model demonstrated that shaking of a freely mobile head, without an additional head impact, could be lethal, and produce significant brain pathology.

Topics: Infant; Humans; Child; Shaken Baby Syndrome; Craniocerebral Trauma; Child Abuse; Brain Injuries; Retinal Hemorrhage

PubMed: 35689145
DOI: 10.1007/s00381-022-05577-6

Authors: Su Hwan Park, Sang Yoon Kim, Sung Who Park...

PURPOSE

To evaluate the clinical patterns of retinopathy in patients who received cardiopulmonary resuscitation (CPR) using wide-field fundus photography and slit-lamp fundus examination.

METHODS

The medical records of patients aged ≥ 18 years who survived after receiving CPR and underwent wide-field fundus photography and slit-lamp fundus examination within 3 months were retrospectively analyzed. Fundus findings, including retinal hemorrhage and cotton wool spots, were investigated. The subjects were categorized into the retinopathy and non-retinopathy groups based on the presence of fundus findings. Systemic and CPR-related factors were analyzed to compare the two groups.

RESULTS

Twenty eyes (10 patients) and 28 eyes (14 patients) were included in the retinopathy and non-retinopathy groups, respectively. The retinopathy group had longer CPR time than the non-retinopathy group (15 ± 11 min vs. 6 ± 5 min, p = 0.027). In the retinopathy group, retinal nerve fiber layer hemorrhage was observed in all eyes, and intraretinal hemorrhage was observed in 55% of the eyes. 80% of hemorrhages were located in the peripapillary or posterior pole. There were no interval changes in visual acuity, intraocular pressure, and central retinal thickness for 6 months. The average remission periods of retinal hemorrhage and cotton wool spots were 6.8 ± 2.6 month and 5.6 ± 2.1 months, respectively. No retinopathy progression was observed.

CONCLUSION

The signs of retinopathy, such as retinal hemorrhages and cotton wool spots, which are found after CPR, mainly occur in patients who receive longer time of CPR and improve over time.

Topics: Humans; Retinal Hemorrhage; Retrospective Studies; Retinal Diseases; Retina; Cardiopulmonary Resuscitation

PubMed: 37735637
DOI: 10.1186/s12886-023-03137-3

Authors: Arpitha Ramesh, Rajesh Ramanjulu, Mahesh P Shanmugam...

Sub-macular hemorrhage poses a potential threat to vision if left untreated. The preferred surgical technique to clear sub-macular hemorrhage includes vitrectomy followed by retinotomy using a 41G needle with subsequent injection of recombinant tissue plasminogen activator (r-tPA) followed by air/SF6 injection into the sub-retinal space. A malleable nature, increased resistance, and the cost of the 41G needle limit its use. We evaluated the safety and efficacy of a 26G needle for retinotomy as a supplement for the 41G needle in a series of six subjects with sub-macular hemorrhage. A slight modification in the procedure was done by injecting air into the sub-retinal space prior to the r-tPA injection. We found that our technique of using the 26G needle for retinotomy is safe and effective due to its stable nature and self-sealing properties. An air injection prior to r-tPA allows for increased bioavailability of the drug by preventing efflux due to its tamponading effect.

Topics: Fibrinolytic Agents; Humans; Macular Degeneration; Minimally Invasive Surgical Procedures; Retinal Hemorrhage; Retrospective Studies; Tissue Plasminogen Activator; Visual Acuity; Vitrectomy

PubMed: 35086260
DOI: 10.4103/ijo.IJO_1726_21