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.
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.
ObjectiveTo explore safe dosage of single intravitreal injection of ganciclovir (IVG) in healthy rabit eyes, and to explore retinal toxicity of different dosage of ganciclovir after continues intravitreal injection into the vitreous cavity of healthy albino rabbit eyes. MethodsTen healthy New Zealand albino rabbits were divided into 5 groups with 2 rabbits in each group. Each group was injected with 1 mg/0.025 ml, 2 mg/0.025 ml, 5 mg/0.025 ml, 10 mg/0.025 ml ganciclovir or 0.025 ml saline (control group). After 1 week of intervention, rabbits were examined by ultra-wide-angle fundus photography, optical coherence tomography (OCT) and full field electroretinogram (ERG). The maximum mixed response of rod and cone cells (Max-R) was measured under dark adaption conditions, cone response (Cone-R) and 30 Hz flicker response (30 Hz-R) were measured under light adaption conditions. Twenty-four healthy New Zealand albino rabbits were randomly divided into a low-dose experimental group, a low-dose control group, a high-dose experimental group, and a high-dose control group, with 6 rabbits in each group, with the right eye as the experimental eye. The rabbits in the high-dose experimental group were continuously injected with ganciclovir 2 mg/0.025 ml, once a week, for a total of 4 times. The rabbits in the low-dose experimental group were injected with 1 mg/0.025 ml ganciclovir, the induction period was 2 times/week, a total of 4 times; the maintenance period was 1 time/week, a total of 2 times. The rabbits in the high-dose control group and the low-dose control group were injected with 0.025 ml normal saline into the vitreous cavity respectively. Full-field ERG examination was performed 1 day before each injection and 1 week after the last injection. Max-R was measured under dark-adapted conditions, and Cone-R and 30 Hz-R were measured under light-adapted conditions. OCT was recorded before the first injection and one week after the last injection. One week after the last injection, the experimental rabbits in each group were sacrificed for hematoxylin-eosin staining, and the retinal structure was observed under a light microscope. The comparison of a-wave and b-wave amplitude of Max-R, Cone-R and 30 Hz-R amplitude at different time was performed by two independent sample nonparametric test. ResultsThere were no abnormal results of fundus photography, OCT and ERG after single intravitral injection of 1 mg or 2 mg ganciclovir. One week after single 5 mg IVG, fundus photography of rabbits showed vascular occlusion and preretinal hemorrhage and ERG showed slight decrease of amplitude of Max-R, Cone-R and 30 Hz-R. One week after single 10 mg IVG, retinal necrosis and exudative changes were also observed. OCT showed edema and unclear retinal structure in the necrotic area. ERG showed significant decrease of amplitude of Max-R, Cone-R and 30 Hz-R. After continuous IVG in high dose and low-dose experimental group, the amplitude of Max-R a wave (Z=-0.160, 0.000) and b wave (Z=-0.321, 0.000), Cone-R a wave (Z=-0.641,-0.641) and b wave (Z=-0.321, -0.160), and 30 Hz-R (Z=-0.321,-0.160) showed no difference compared to control group. No histologic evidences of retinal microstructure abnormalities were found in both groups. OCT and fundus photography before and after the intervention did not show any difference, either. ConclusionThere was no retinal toxicity of continuous 1 mg or 2 mg IVG recorded in albino rabbits.
Primary vitreoretinal lymphoma (PVRL) is a rare type of non-Hodgkin's lymphoma with poor prognosis and the optimal treatment has yet to be determined. Its treatment has evolved from enucleation to ocular radiotherapy, systemic chemotherapy and intravitreal chemotherapy. Radiotherapy can effectively eradicate tumor cells but ocular recurrences are common. Systemic chemotherapy has become the mainstream option but there are problems with only-partial response of PVRL and high rate of recurrence. Intravitreal chemotherapy, primarily used as adjunctive to systemic chemotherapy, has achieved high remission rate and low rate of recurrence as well as with limited ocular complications. The tumor cells were cleared and the visual function preserved. However, issues about the drug applied, treatment protocols and goals of intravitreal chemotherapy, whether for visual preservation or survival improvement, are worthy for further study.
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.
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 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.
ObjectiveTo evaluate the efficacy of intravitreal injection (IVI) of expansile gas alone to treat idiopathic full-thickness macular hole (FTMH).MethodsThis is a prospective interventional case series. Twenty FTMH patients (26 eyes) who underwent IVI with expansile gas alone were enrolled in this study. There were 5 males (5 eyes) and 21 females (21 eyes), with the mean age of (59±12) years. All patients received the best corrected visual acuity (BCVA), slit lamp microscope, indirect ophthalmoscopy, fundus color photography and three-dimensional optical coherence tomography (OCT) examinations. The BCVA was measured using the international standard visual acuity chart, and the results were converted to the logarithm of the minimum angle of resolution visual acuity. The diameters of macular holes and the interface between vitreous and macular were observed by OCT (Topcon, OCT-2000). Based on the diameter, the holes were classified as small FTMH (equal or lesser than 250 μm), medium FTMH (more than 250 μm but equal or lesser than 400 μm) and large FTMH (more than 400 μm). The mean BCVA was 0.85±0.29. There were 7, 10 and 9 eyes with small, medium and large FTMH. There were 10 eyes with vitreous- macular traction (VMT). All the eyes received IVI of 0.2 ml C3F8 followed facedown positioning for 7-14 days. The follow-up ranged from 1 to 23 months. The BCVA, FTMH closure and complications were observed. If holes failed to close at 1 month after IVI, vitrectomy combined with internal limiting membrane (ILM) peeling and C3F8 tamponade would be performed for these eyes.ResultsFTMHs was able to close in 17/26 eyes (65.4%) had hole closure, failed to close in 9 /26 eyes (34.6%). All 10 eyes with VMT achieved vitreous-macula separation after IVI of gas. The eyes failed in the closure initially with IVI of gas alone, all succeed with hole closure after vitrectomy combined with ILM peeling and C3F8 tamponade. The closure rate of small (6 eyes), medium (8 eyes) and large FTMH (3 eyes) was 85.7%, 80.0% and 33.3% respectively. The diameter of FTMHs in holes-closure eyes and failed-closure eyes was (307.8±122.8), (431.6±128.4) μm respectively, the difference was significant (t=?2.407, P=0.024). VMT was found in 6 eyes and 4 eyes in holes-closure group and failed-closure group, respectively, the difference was significant (t=?2.196, P=0.038). The mean preoperative BCVA was 0.51±0.36. There was a significant difference between pre-and postoperative BCVA (t=4.758, P<0.05). Two eyes developed local retinal detachment, which achieved hole closure and retinal reattachment after vitrectomy.ConclusionIVI of expansile gas alone is an effective way in treating FTMH with a diameter smaller than 400 μm and with VMT before surgery.
ObjectiveTo compare the efficacy of pars plana vitrectomy (PPV) combined with subretinal or intravitreal injection of Conbercept for the treatment of refractory diabetic macular edema (DME). MethodsA retrospective case control study. From June 2022 to March 2024, 32 eyes of 32 patients with refractory DME diagnosed at The Affiliated Eye Hospital of Nanchang University were included in the study. There were 17 male cases with 17 eyes and 15 female cases with 15 eyes. Age was (57.44±8.99) years old; The duration of diabetes was (12.72±6.11) years. All patients had received regular treatment with anti-vascular endothelial growth factor (VEGF) drugs or corticosteroid drugs for at least 5 times, and had undergone focal retinal laser photocoagulation or panretinal laser photocoagulation, the central macular thickness (CMT) persisted or decreased by less than 50 μm. All affected eyes underwent best-corrected visual acuity (BCVA), intraocular pressure, optical coherence tomography (OCT), microperimetry, and laboratory glycated hemoglobin (HbA1c) testing. BCVA was measured using a standard logarithmic visual acuity chart, and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis. CMT was measured using an OCT device. Microperimetry was performed using an MP-3 microperimeter, recording the mean sensitivity (MS) of the retina within a 12° range of the fovea. The affected eyes were treated with 23G PPV combined with internal limiting membrane peeling and either macular subretinal or intravitreal injection of Conbercept, and were divided into subretinal injection group and the intravitreal injection group, each consisting of 16 cases and 16 eyes. The same equipment and methods as before surgery were used for related examinations at 1, 3, and 6 months post-surgery. Changes in BCVA, CMT, and MS were observed and compared, as well as the number of additional anti-VEGF treatments required within 6 months after surgery. Intergroup comparisons were made using independent samples t tests, and repeated measures data were analyzed using repeated measures analysis of variance. ResultsThe age (t=-0.271), gender composition (χ2=0.001), duration of diabetes (Z=-0.868), HbA1c (t=-0.789), intraocular pressure (t=1.689), logMAR BCVA (t=1.393), CMT (t=-0.613), MS (Z=-0.132), and the number of anti-VEGF injections (t=-0.752) between the subretinal injection group and the intravitreal injection group showed no statistically significant differences (P>0.05). The within-subject effects comparison of BCVA, CMT, and MS at 1, 3, and 6 months post-surgery compared to pre-surgery for all affected eyes showed statistically significant differences (F=8.060, 125.722, 39.054; P<0.05). The overall comparison of logMAR BCVA between the subretinal and intravitreal injection groups post-surgery showed no statistically significant difference (F=0.662, P=0.422), however, comparisons of CMT (F=4.540) and MS (F=6.066) showed statistically significant differences (P<0.05). At 1, 3, and 6 months post-surgery, comparisons of logMAR BCVA between the two groups showed no statistically significant differences (t=-0.123, 0.239, 1.087; P>0.05), comparisons of CMT showed statistically significant differences (t=-3.474, -4.832, -2.482; P<0.05), comparisons of MS showed statistically significant differences at 1 and 3 months (t=-2.940, -2.545; P<0.05), but not at 6 months (t=-1.527, P>0.05). At 6 months post-surgery, the number of additional intravitreal anti-VEGF injections required in the subretinal and intravitreal injection groups showed a statistically significant difference (Z=-2.033, P=0.042). During the follow-up period and at the final follow-up, no complications such as injection site bleeding, retinal detachment, vitreous hemorrhage, macular hole, or retinal pigment epithelial tear or atrophy occurred in all affected eyes. ConclusionCompared with intravitreal injection, subretinal injection of Conbercept for the treatment of refractory DME has more advantages in reducing macular edema and improving visual function in the macular area, and also reduces the number of postoperative anti-VEGF drug treatments.
Noninfectious uveitic macular edema (NIU-ME) is a major cause of visual impairment in patients with uveitis. Intravitreal route can control inflammation rapidly, reduce macular edema, and improve vision with relatively lower doses of the drug. Currently, several intravitreal injection drugs have been used for the treatment of NIU-ME. Cataract and elevated intraocular pressure are the major complications. Due to its efficacy and safety, intravitreal drugs have gradually become an effective alternative to systemic treatment, especially in patients with unilateral disease. However, more studies are needed on drug selection, timing of injection and combination therapy in clinical practice. There are various treatments for NIU-ME, and the ultimate treatment should be individualized based on the severity of the disease, the risk/benefit ratio of each therapy, and the patient's tolerance.