Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.
ObjectiveTo observe the clinical effect of subretinal injection and intravitreal injection of conbercept in the treatment of polypoid choroidal vasculopathy (PCV). MethodsA prospective, randomized double-blind controlled study. From June 2022 to January 2023, 35 patients of 35 eyes with PCV diagnosed at Affiliated Eye Hospital of Nanchang University were included in the study. All patients were first-time recipients of treatment. Best corrected visual acuity (BCVA), optical coherence tomography (OCT), and indocyanine green angiography (ICGA) were performed in all affected eyes. BCVA was performed using an international standard visual acuity chart and converted to logarithmic minimum resolved angle (logMAR) visual acuity for statistical purposes. Enhanced depth imaging with OCT instrument was used to measure the macular retinal thickness (MRT), subfoveal choroidal thickness (SFCT), and pigment epithelium detachment (PED) height. Randomized numerical table method was used to divide the patients into subretinal injection group (group A) and vitreous cavity injection group (Group B), 18 cases with 18 eyes and 17 cases with 17 eyes, respectively. Comparison of age (t=0.090), disease duration (t=−0.370), logMAR BCVA (t=−0.190), MRT (t=0.860), SFCT (t=0.247), and PED height (t=−0.520) between the two groups showed no statistically significant difference (P＞0.05). The eyes of group A were given one subretinal injection of 10 mg/ml conbercept 0.05 ml (containing conbercept 0.5 mg), and subsequently administered on demand (PRN); eyes in group B were given intravitreal injection of 10 mg/ml conbercept 0.05 ml (containing conbercept 0.5 mg). The treatment regimen was 3+PRN. Lesions were categorized into active and quiescent according to the results of post-treatment OCT and BCVA. Active lesions were treated with intravitreal injection of conbercept at the same dose as before; stationary lesions were followed up for observation. BCVA and OCT were performed at 1, 2, 3, 6 and 9 months after treatment; ICGA was performed at 3, 6 and 9 months. BCVA, MRT, SFCT, and PED height changes before and after treatment were compared and observed in the affected eyes of the two groups. Independent sample t-test was used to compare between the two groups. ResultsWith the prolongation of time after treatment, the BCVA of the affected eyes in groups A and B gradually increased, and the MRT, SFCT, and PED height gradually decreased. Compared with group B, at 2, 3, 6, and 9 months after treatment, the BCVA of group A was significantly improved, and the difference was statistically significant (t=−2.215, −2.820, −2.559, −4.051; P＜0.05); at 1, 2, 3, 6, and 9 months after treatment, the MRT of the affected eyes in group A (t=−2.439, −3.091, −3.099, −3.665, −5.494), SFCT (t=−3.370, −3.058, −3.268, −4.220, −4.121), and PED height (t=−3.460, −4.678, −4.956, −5.368, −6.396) were significantly reduced, and the differences were statistically significant (P＜0.05). No complications such as intraocular inflammation, high intraocular pressure, or vitreous hemorrhage occurred in any of the affected eyes during or after treatment. ConclusionCompared with the intravitreal injection of conbercept, the subretinal injection of conbercept can more effectively reduce the height of MRT, SFCT, PED height, and improve the visual acuity of the affected eyes with PCV.
Corticosteroids, anti-vascular endothelial growth factor, antibiotics and antiviral were the main 4 classes of drugs for intravitreal injection. Depending on the class and volume of medication, age and gender of patients, ocular axial lengths or vitreous humour reflux, intraocular pressure (IOP) can be elevated transiently or persistently after intravitreal injection. Transient IOP elevation occurred in 2 weeks after intravitreal injection, and can be reduced to normal level for most patients. Only a small portion of such patients have very high IOP and need intervention measures such as anterior chamber puncture or lowering intraocular pressure by drugs. Long term IOP elevation is refers to persistent IOP increase after 2 weeks after intravitreal injection, and cause optic nerve irreversible damage and decline in the visual function of patients. Thus drug or surgical intervention need to be considered for those patients with high and long period of elevated IOP. Large-scale multicenter clinical trials need to be performed to evaluate the roles of the drug and patients factors for IOP of post-intravitreal injection, and to determine if it is necessary and how to use methods reducing IOP before intravitreal injection.
Diabetic macular edema (DME) is the most threatening complication of diabetic retinopathy that affects visual function, which is characterized by intractability and recurrent attacks. Currently, the clinical routine treatments for DME mainly include intravitreal injection, grid laser photocoagulation in the macular area, subthreshold micropulse laser, periocular corticosteroid injection, and vitrectomy. Although conventional treatments are effective for some patients, persistent, refractory, and recurrent DME remains a clinical challenge that needs to be urgently addressed. In recent years, clinical studies have found that certain combination therapies are superior to monotherapy, which can not only restore the anatomical structure of the macular area and effectively reduce macular edema but also improve visual function to some extent while reducing the number of treatments and the overall cost. This makes up for the shortcomings of single treatment modalities and is highly anticipated in the clinical setting. However, the application of combination therapy in clinical practice is relatively short, and its safety and long-term effectiveness need further exploration. Currently, new drugs, new formulations, and new therapeutic targets are still under research and development to address different mechanisms of DME occurrence and development, such as anti-vascular endothelial growth factor agents designed to anchor repetitive sequence proteins with stronger inhibition of vascular leakage, multiple growth factor inhibitors, anti-inflammatory agents, and stem cell therapy. With the continuous improvement of the combination application of existing drugs and treatments and the development of new drugs and treatment technologies, personalized treatment for DME will become possible.
ObjectiveTo observe the ocular clinical features and efficacy of young infants with incontinentia pigmenti (IP). MethodsA retrospective study. Clinical data of 18 young infants with IP aged 0-3 months in the Department of Ophthalmology of Henan Children's Hospital from October 2017 to February 2019 were collected in this study. All patients were underwent fundus examination under topical anesthesia or general anesthesia. Among them, 9 cases were underwent genetic testing. Patients were determined whether to treated with retinal laser photocoagulation (LIO) or intravitreal conbercept (IVC, 0.25 mg/0.025 ml) according to the condition of eyes. The followed-up time ranged from 4months to 43 months. The ocular clinical features and treatment were observed. ResultsThere were 1 male and 17 females of the 18 patients. The age of first visit were 1.2±1.0 months (2 d-3 months). All cases had typical skin lesions, 4 cases had neurological symptoms, 10 cases had tooth abnormalities, and 4 cases had cicatricial alopecia. Among the 9 cases that were underwent genetic testing, 5 cases were deleted in exons 4-10 of the IKBKG gene and 1case were a heterozygous mutation c.1124delT in exon 9 of the IKBKG gene. Among the 36 eyes, 21 eyes of 13 cases with incontinentia pigmenti-associated ocular diseases were all retinopathy (58.3%,21/36). Retinopathy of 9 cases were asymmetrical (69.2%,9/13). Among the 21 eyes, 3 eyes were simple retinal pigment abnormalities (14.3%,3/21) and 18 cases had retinal vascular lesion (85.7%, 18/21). Among the 36 eyes, 8 eyes were treated; 4 eyes were underwent LIO; 3 eyes were treated with IVC; 1 eye was treated with LIO combined with IVC. They were all improved significantly after the operation without serious complications. 1 eye with retinal detachment did not undergo surgical treatment due to guardian reasons. Perceptual exotropia and eyeball atrophy was found during the follow-up. ConclusionsThe onset of IP-related ocular anomalies is early. The early anomalies were mainly retinal vascular abnormalities. Treatment in early time is effective.
Objective To evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) for treatment of macular edema associated with retinal vein occlusion (RVO). Methods This study was a six-month, randomized, double-masked, sham-controlled, multicenter, phase 3 clinical trial with a 2-month open-label study extension. Patients with branch or central RVO received DEX (n=129) or sham procedure (n=130) in the study eye at baseline; all patients who met re-treatment criteria received DEX at month 6. Efficacy measures included Early Treatment Diabetic Retinopathy Study (ETDRS), best-corrected visual acuity (BCVA), and central retinal thickness (CRT) on optical coherence tomography. Results Time to ≥15-letter BCVA improvement from baseline during the first 6 months (primary endpoint) was earlier with DEX than sham (P＜0.001). At month 2 (peak effect), the percentage of patients with ≥15-letter BCVA improvement from baseline was DEX: 34.9%, sham: 11.5%; mean BCVA change from baseline was DEX: 10.6±10.4 letters, sham: 1.7±12.3 letters; and mean CRT change from baseline was DEX: −407±212 μm, sham: −62±224 μm (all P＜0.001). Outcomes were better with DEX than sham in both branch and central RVO. The most common treatment-emergent adverse event was in-creased intraocular pressure (IOP). Increase sin IOP generally were controlled with topical medication. Mean IOP normalized by month 4, and no patient required incisional glaucoma surgery. Conclusions DEX had a favorable safety profile and provided clinically significant benefit in a Chinese patient population with RVO. Visual and anatomic outcomes were improved with DEX relative to sham for 3 - 4 months after a single implant.
ObjectiveTo observe the efficacy of parsplana vitrectomy (PPV) combined with 0.7 mg dexamethasone sustained-release Ozurdex intravitreal implantation in the treatment of children with ocular toxocariasis (OT). MethodsA retrospective clinical study. Fifty-three pediatric patients (53 eyes) diagnosed with OT and underwent PPV in Beijing Tongren Eye Center of Beijing Tongren hospital from March 2015 to December 2021 were included. There were 30 males and 23 females, with an average age of 7.07±3.45 (4-14) years; all were unilateral. Color Doppler imaging, fundus color photography, optical coherence tomography examinations were performed for patients who can cooperated with the examiners. Forty-three eyes were examined by best corrected visual acuity (BCVA); 47 eyes were examined by intraocular pressure; 29 eyes were examined by ultrasound biomicroscopy. According to the location of granuloma, OT was divided into posterior pole granulomatous type (posterior type), peripheral granulomatous type (peripheral type), and chronic endophthalmitis type. According to whether Ozurdex was implanted into the vitreous cavity after PPV, the children were divided into the oral glucocorticoid group after PPV (group A) and the PPV combined with vitreous cavity implantation of Ozurdex group (group B), 37 cases with 37 eyes and 16 cases with 16 eyes, respectively. There was no significant difference in age (t=0.432), sex composition ratio (χ2=0.117), BCVA (χ2=0.239), and clinical type (χ2=0.312) between the two groups (P＞0.05). The follow-up time after surgery was ≥5 months. The intraocular pressure at 1 week and 1, 3, and 6 months after surgery, the changes of BCVA and the occurrence of complications such as concurrent cataract and epimacular membrane were observed at the last follow-up, and the incidence of obesity in the children during the follow-up period was recorded. The measurement data between groups was compared by independent sample t test; the enumeration data was compared by χ2 test. ResultsOne month after the operation, the intraocular pressure of group A and group B were 15.17±6.21 and 25.28±10.38 mm Hg (1 mm Hg=0.133 kPa) respectively; the intraocular pressure of group B was significantly higher than that of group A, the difference was statistically significant (t=0.141, P=0.043). At the last follow-up, there was no significant difference in the percentage of visual acuity improvement between the two groups (χ2=0.315, P=0.053); there was no significant difference in the incidence of concurrent cataract and epimacular membrane (χ2=0.621, P＞0.05). Among the 37 cases in group A, 32 cases (86.5%, 32/37) developed obesity symptoms during the follow-up period. ConclusionPPV combined with intravitreal implantation of Ozurdex and oral glucocorticoid after PPV can effectively improve the visual acuity of the affected eye; the incidence of complications is similar, however, the incidence of obesity after oral glucocorticoid is higher.
ObjectiveTo evaluate the safety and efficacy of the intravitreal methotrexate treatment in patients with primary vitreoretinal lymphoma (PVRL). MethodsRetrospective non-comparative interventional case series. Fourteen patients (26 eyes) with biopsy-proven PVRL were included in the study. All patients received examination of Snellen chart visual acuity, fundus color photography and optical coherence tomography (OCT). Among the 24 eyes with recordable visual acuity, 17 eyes has initial visual acuity≥0.1 (0.45±0.20) and 7 eyes with initial visual acuity ranged from light perception to hand movement. The vitreous opacities and (or) subretinal yellowish-white lesions and retinal pigment epitheliumuplift were observed in all eyes. All eyes were treated with intravitreal methotrexate (4000 μg/ml, 0.1 ml) injections according to a induction-consolidation-maintenance regimen. For 26 treated eyes, each received an average of (11.5±6.3) injections. Twenty eyes had finished theintraocular chemotherapy, while 6 eyes had not. Eight of 20 eyes were clinically confirmed free of tumor cells by diagnostic vitrectomy, 12 eyes were still with tumor cell involvement.The follow-up was ranged from 2 to 48 months, the mean time was 18 months. The examination of BCVA, fundus color photography and OCT were performed. No tumor cell was defined as clinical remission. Visual acuity was scored as improved or declined obviously (improved or declined 2 lines) or mild improved or declined (changed within 2 lines). ResultsTwenty eyes achieved clinical remission after (3.5±3.6) injections, 12 eyes of 20 eyes with tumor cell involvement before chemotherapy achieved clinical remission after (5.8±3.0) injections. The mean visual acuity of seventeen eyes with initial visual acuity 0.1 in induction phase and at the end of treatment were 0.36±0.23 and 0.56±0.20, respectively. Compared with before treatment, the visual acuity was mild declined in induction phase (t=1.541, P>0.05), but mild improved at the end of treatment (t=2.639, P<0.05). The visual acuity at the end of treatment in 7 eyes with initial visual acuity<0.1 was ranged from no light perception to 0.1. Of 14 patients, 2 patients have been fatal because of brain lesions progression at 42 and 48 months after diagnosis of primary central nervous system lymphoma. No ocular recurrence was noted during the follow-up in 20 eyes who finished intraocular chemotherapy. ConclusionsPVRL patients can achieve clinical remission after (3.5±3.6) injections by intravitreal chemotherapy of methotrexate, and the visual acuity improved mildly. No ocular recurrence was found during follow-up.
ObjectiveTo compare and analyze the application of anti-vascular endothelial growth factor (VEGF) drugs for intravitreal injection in the real world before and after the establishment of one-stop intravitreal injection center, as well as the advantages and disadvantages of different management modes. MethodsA retrospective clinical study. A total of 4 015 patients (4 659 eyes) who received anti-VEGF drugs for ocular fundus diseases at the Tianjin Medical University Eye Hospital from July, 2018 to June, 2022 were included in the study. There were 2 146 males and 1 869 females. The ocular fundus diseases in this study were as follows: 1 090 eyes of 968 patients with wet age-related macular degeneration (wAMD); 855 eyes of 654 patients with diabetic macular edema (DME); 1 158 eyes of 980 patients with diabetic retinopathy (DR); 930 eyes of 916 patients with macular edema secondary to retinal vein occlusion (RVO-ME). A total of 294 eyes of 275 patients with choroidal neovascularization secondary to pathological myopia (PM-CNV); 332 eyes of 222 patients with other fundus diseases. A total of 13 796 anti-VEGF needles were injected. A total of 1 252 patients (1 403 eyes) from July 2018 to June 2020 were regarded as the control group. From July 2020 to June 2022, 2 763 patients (3 256 eyes) who received anti-VEGF treatment in the intravitreal injection center were regarded as the observation group. The total number of intravitreal injection needles, the distribution of anti-VEGF therapy in each disease according to disease classification, the proportion of patients who chose the 3+ on-demand treatment (PRN) regimen and the distribution of clinical application of different anti-VEGF drugs were compared between the control group and the observation group. The waiting time and medical experience of patients were investigated by questionnaire. χ2 test was used to compare the count data between the two groups, and t test was used to compare the measurement data. ResultsAmong the 13 796 anti-VEGF injections in 4 659 eyes, the total number of anti-VEGF drugs used in the control and observation groups were 4 762 and 9 034, respectively, with an average of (3.39±3.78) and (2.78±2.27) injections per eye (t=6.900, P＜0.001), respectively. In the control and observation groups, a total of 1 728 and 2 705 injections of anti-VEGF drugs were used for wAMD with an average of (5.14±4.56) and (3.59±2.45) injections per eye, respectively; a total of 982 and 2 038 injections of anti-VEGF drugs were used for DME with an average of (4.36±4.91) and (3.24±2.77) needles per eye, respectively. Additionally, a total of 942 and 2 179 injections of anti-VEGF drugs were injected for RVO-ME with an average of (3.98±3.71) and (3.14±2.15) injections per eye, respectively; a total of 291 and 615 injections of anti-VEGF drugs were injected for PM-CNV with an average of (3.31±2.63) and (2.99±1.69) injections per eye, respectively. A total of 683 and 1 029 injections of anti-VEGF drugs were injected for DR with an average of (1.60±1.26) and (1.41±1.05) injections per eye, respectively. The clinical application and implementation of "3+PRN" treatment were as follows: 223 (66.4%, 223/336) and 431 eyes (57.2%, 431/754) in the wAMD (χ2=8.210, P=0.004), 75 (33.3%, 75/225) and 236 (37.5%, 236/630) eyes in the DME (χ2=1.220, P＞0.05), and 97 (40.9%, 97/237) and 355 eyes (51.2%, 355/693) in the RVO-ME (χ2=7.498, P=0.006), 39 (44.3%, 39/88) and 111 eyes (53.9%, 111/206) in the PM-CNV ( χ2=2.258, P＞0.05), respectively. In addition, the results of the questionnaire survey showed that there were significant differences between the control and observation groups regarding the time of appointment waiting for surgery (t=1.340), time from admission to entering the operating room on the day of injection (t=2.780), time from completing preoperative treatment preparation to waiting for entering the operating room (t=8.390), and time from admission to discharge (t=6.060) (P＜0.05). ConclusionsThe establishment of a one-stop intravitreal injection mode greatly improved work efficiency and increased the number of injections. At the same time, the compliance, waiting time, and overall medical experience of patients significantly improved under centralized management.
Nowadays, one of the most challenging aspects of retinoblastoma (RB) therapy is how to control the resistant or recurrent viable vitreous seeds, for which intravenous chemotherapy appears to be ineffective. Recently, intravitreal chemotherapy offers another option to control advanced stage and vitreous seeds of RB, and may be a promising new approach to RB therapy. However, intravitreal injection for RB patients raises considerable controversy due to concerns of possible extraocular extension along the injection route, and should not replace the primary standard of care for bilateral RB or group E eyes of RB. Close follow-up and further studies are needed to determine appropriate indications, to determine the effective drugs and concentrations, to optimize RB therapy protocols and to investigate the relationship between long-term efficacy and toxicities.