Objective To compare the clinic therapeutic effect of intravitreal ranibizumab injection versus photodynamic therapy (PDT) combined with intravitreal ranibizumab injection for idiopathic choroidal neovascularizatio (ICNV), and to investigate the clinical effect and safety of treatment. Methods A randomized controlled clinical prospective study was performed for 27 patients (27 eyes) diagnosed as ICNV. Fourteen patients were assigned to receive PDT and intravitreal ranibizumab injection (combination roup.n=14); the control group was treated with only intravitreal ranibizumab injection (single group, n=13).The combination group was treated with an intravitreal injection of ranibizumab (0.5 mg/0.05 ml) 1 week after PDT. The bestcorrected visual acuity (BCVA) (logMAR), examination of the ocular fundus, fluorescence fundus angiography (FFA), indocyanine green angiography (ICGA) and optical coherence tomography (OCT) were performed respectively at 1, 2, 3, 6 and 12 months after treatment. If choroidal neovascularization (CNV) was only partially regressed or the leakage went on during follow-up, those patients were re-injected with ranibizumab. Results After 12 months, the average vision is 0.22plusmn;0.11 in single group, and 0.21plusmn;0.12 in combination group, and the differences were not significant (t=0.187, P=0.853). In single group FFA and ICGA showed completely closed CNV in 10 eyes (77.92%), and almost closed CNV in 3 eyes (23.08%) with obvious reduction of fluorescence leakage. In combination group FFA and ICGA showed completely closed CNV in 12 eyes (85.71%), and almost closed CNV in 2 eyes (14.29%) with obvious reduction of fluorescence leakage; OCT showed the subretinal fluid absorption and reduction of CNV. The average macular retinal thickness (MRT) in single groups is （167.96plusmn;10.69） m, and in combination groups is （171.64plusmn;11.30）m. In single and combination groups MRT decreased significantly at the final follow-up, but no significant differences in both groups (t=-0.887.P=0.389). The average number of intravitreal injection was （1.5plusmn;0.7） in combination group and （2.4plusmn;1.0） in single group (t=2.821，P=0.009). There were no ocular or systemic adverse events observed except for one patient with subconjunctival hemorrhage in the single group.Conclusions Intravitreal ranibizumab injection and PDT combined with intravitreal bevacizumab injection are both effective and safe for the patients with ICNV. The combined therapy can induce CNV regression, fundus hemorrhage and exudation absorption more effectively, and have less recurred CNV and side effects.
The core idea of comparative effectiveness research (CER) refers to "study in the real-world" which can be considered as the extension of evidence-based medicine. So far CER has arouse wide concern. CER includes many intervention trials and observational studies, including systematic reviews/meta-analyses, effectiveness randomized controlled trials, and registry trials. Database is an important platform for CER. CER has better feasibility and can provide useful evidence for "real-world" decision-making. However, it also has limitations such as difficult control of confounding factors. It still needs to be further studied due to its immature methodological base. CER has been already applied in some neurological fields, with internationally-recommended research priorities for CER in neurology.
ObjectiveTo compare the visual outcomes of treatment with intravitreal ranibizumab alone or in combination with photodynamic therapy (PDT) in patients with polypoidal choroidal vasculopathy (PCV). MethodsIn this retrospective and comparative study, 36 eyes of 36 patients with PCV were enrolled. Eighteen eyes received 0.5 mg (0.05 ml) ranibizumab injection only (simple injection group) and the other 18 eyes underwent combination therapy of ranibizumab injection and PDT (combination treatment group). Intravitreal ranibizumab was given at the third day after PDT. Re-treatment was considered in clinic examination. The minimum re-treatment interval was 3 months for combination therapy and 1 month for ranibizumab. Best corrected visual acuity (BCVA) of logarithm of the minimum angle of resolution (logMAR) at baseline and each follow-up visit at 1, 3, 6, 12 month was measured as a primary outcome, and complications also observed in every follow-up. ResultsNo complications occurred in these 36 patients during the treatment or follow-up, such as retinal detachment, sustained high intraocular pressure, retinal holes, intraocular inflammation, and systemic adverse reactions. The average times of ranibizumab injections of simple injection group and combined treatment group were (3.00±0.84) and (1.89±0.68) times respective, and the difference was significant (t=4.370, P=0.000). The logMAR BCVA of the first and third month after initial treatment between two groups were significant different (t=0.668, 0.940; P>0.05). However, there was no significant difference between them at the 6th and 12th month (t=2.188, 2.547; P<0.05). In the last follow-up, the logMAR BCVA were improved in simple injection group and combination treatment group compared to the pre-treatment values (t=3.351, 9.408; P=0.012, 0.000). In simple injection group, visual acuity was improved in 3 eyes (16.7%), stable in 13 eyes (72.2%) and decreased in 2 eyes (11.1%). In combination treatment group, visual acuity was improved in 4 eyes (22.2%), stable in 13 eyes (72.2%) and decreased in 1 eyes (5.6%). ConclusionsIntravitreal ranibizumab injection and combined with PDT are both effective to improve vision in patients with PCV. Visual acuity was the same between the two treatments in 3 months after initial treatment; however 6 to 12 months after first treatment, patients received PDT combined with intravitreal ranibizumab injection had better visual acuity than those received the intravitreal ranibizumab injection only.
ObjectiveTo compare the results of internal limiting membrane (ILM) peeling with and without ILM transplantation to treat idiopathic macular hole (IMH) with hole form factor (HFF)<0.6. MethodsForty patients (40 eyes) of IMH with HFF<0.6 who underwent pars plana vitrectomy (PPV) were enrolled in this study. 20 eyes was performed PPV combined with ILM peeling (ILM peeling group), the other 20 eyes was performed PPV combined with ILM peeling and ILM transplant (ILM transplant group). The follow-up was ranged from 3 to 6 months with an average of 4 months. The changes of closing rate of hole, best corrected visual acuity (BCVA), photoreceptor inner segment/outer segment (IS/OS) junction defect diameter and amplitude of wave P1 of ring 1 and ring 2 by multifocal electroretinogram (mfERG) were comparatively analyzed for the two groups. ResultsIn 3 months after surgery, the IMH closing rate was 70% (14/20) in the ILM peeling group, and 100% (20/20) in the ILM transplant group, the difference between these two groups was significant (χ2=7.059, P<0.05). Postoperative BCVA was improved obviously in the two groups compared to preoperative BCVA, the difference was significant (t=4.017, 4.430; P<0.05). The rate of BCVA improvement in the ILM peeling group and ILM transplant group were 80% and 85%, the difference was not significant (χ2=0.173, P>0.05). The rate of significantly BCVA improvement in the ILM peeling group and ILM transplant group were 35% and 70%, the difference was significant (χ2=4.912, P<0.05). IS/OS junction defect (t=6.368, 6.635; P<0.05) and amplitude of wave P1 of ring 1 (t=2.833, 4.235) and ring 2 (t=2.459, 4.270) by mfERG in the two groups were improved after operation. The differences of postoperative IS/OS junction defect (t=2.261, P<0.05) and amplitude of wave P1 of ring 2 between the two groups were significant (t=2.282, P<0.05), but the differences of postoperative amplitude of wave P1 of ring 1 between two groups was not different (t=1.800, P>0.05). ConclusionPPV combined with ILM peeling and ILM transplantation can significantly improve the closure rate and vision of IMH with HFF<0.6.
ObjectiveTo compare the efficacy of photodynamic therapy (PDT) alone or in combined with ranibizumab versus ranibizumab monotherapy (intravitreal injection, IVR) in patients with polypoidal choroidal vasculopathy (PCV). Methods80 eyes of 72 patients with PCV were enrolled into this retrospective and comparative study according to their therapeutic plan. 30 eyes of 28 patients, 28 eyes of 30 patients and 22 eyes of 21 patients were divided into PDT group, ranibizumab 0.5 mg group (IVR group) or the combination group, respectively. The patients with PCV were diagnosed according to clinical symptoms, optical coherence tomography (OCT) and fluorescent indocyanine green angiography (ICGA). The baseline best-corrected visual acuity (BCVA) before treatment was more than 0.05, and there was no retinal fibrosis and scar for all patients. There was no statistical difference of age (F=0.187), gender (χ2=0.423), average BCVA (F=1.120) and central retinal thickness (CRT) (F=0.431) among three groups (P > 0.05). They had not received any treatment before. Patients received verteporfin PDT in PDT group, 3 consecutive monthly IVRs starting day 1 in IVR group, and 3 IVRs after 3 days, 1 month, 2 months of PDT starting day 1 in combination group. Re-treatment was considered 3 months later if the follow up shown no changes in fundus photography, OCT and ICGA. The average follow-up time was 19 months. BCVA at baseline and follow-up visit at 1, 3, 6, 12 months was measured, and the proportion of patients with ICGA-assessed complete regression of polyps at month 6 was recorded as primary outcome. The CRT was measured at baseline and 6 months as secondary outcome. ResultsThere were significant difference of BCVA at 1, 3, 6 and 12 months among three groups(F=5.480, 5.249, 3.222, 4.711; P < 0.05). The average BCVA was significantly better at 1, 3, 6, 12 month than that at baseline(t=-6.632, -4.127, -3.904, -4.494; P < 0.05) in combination group, and was significantly better at 3, 6, 12 months than that at baseline (t=-5.636, -3.039, -3.833; P < 0.05) in IVR group. However there was no significant difference of the average BCVA in PDT group between follow-up at 1, 3, 6, l 2 months and baseline (t=1.973, 0.102, -0.100, -0.761; P > 0.05). The proportion of patients with complete regression of polyps at 6 months was higher in PDT (76.7%) or combination group (68.2%) than IVR group (35.7%) (χ2=0.003, 0.025; P < 0.05). There was no significant difference of CRT among 3 groups at baseline (P=0.651). The mean CRT decreased in all 3 treatment groups over 6 months (t=5.120, 3.635, 5.253; P < 0.05), but there was no significant difference of CRT among 3 groups (F=1.293, P > 0.05). ConclusionsThree therapies could effectively decrease CRT. IVR or IVR combined with PDT are both more effective than PDT therapy to improve vision of PCV patients. PDT or PDT combined with IVR was superior to IVR pnly in achieving complete regression of polyps in 6 months in PCV patients.
Objective To evaluate the effect of 27G pars plana vitrectomy (PPV) and 25G PPV on idiopathic epiretinal membrane (IMEM). Methods Thirty-eight eyes of 38 patients with IMEM were enrolled into this retrospective and comparative study. Eighteen eyes were treated with 27G PPV (group A), 20 eyes underwent 25G PPV (group B) voluntarily. The best corrected visual acuity (BCVA), intraocular pressure (IOP), slit-lamp microscope, indirect ophthalmoscopy, fundus color photograph, ocular coherence tomography (OCT) and counting of corneal endothelial cells (CEC) were examined before the surgery. BCVA results were converted to the logarithm of the minimum angle of resolution (logMAR) visual acuity. There was no statistically significant difference between two groups in terms of BCVA, IOP, foveal macular thickness (FMT), the counting of CEC and CEC hexagon rate before the surgery (t=1.627, 0.860, 0.293, 1.238, 0.697;P＞0.05). All operations were performed by the same doctor. Operation time for vitrectomy and peeling membrane was recorded. BCVA, IOP, OCT, FMT, counting of CEC and the improvement of metamorphopsia were observed on 1, 7 days and 1, 3 months after PPV. Results The mean operation time for vitrectomy in group A and B were (6.7±2.8), (10.5±3.3) min, respectively. The mean operation time for vitrectomy in group A was significantly longer than that in group B (t=3.084,P＜0.05). The mean operation time for peeling membrane in group A and B were (10.2±5.2), (11.0±5.9) min, respectively. There was no statistically significant difference between two groups in terms of the time for peeling membrane (t=1.970,P=0.187). On 1, 7 days and 1, 3 months after PPV, the difference of BCVA (t=1.463, 0.683, 0.961, 1.226;P=0.833, 0.509, 0.699, 0.744) and IOP (t=1.314, 1.262, 0.699, 1.116;P=0.763, 0.721, 0.534, 0.712) between two groups were not statistically significant. On 1 day after PPV, there were 2 eyes and 5 eyes with ＜9 mmHg (1 mmHg=0.133 kPa) IOP in group A and B. On 7 days and 1, 3 months after PPV, the difference of FMT between two groups were not statistically significant (t=1.257, 1.368, 1.437;P=0.735, 0.745, 0.869). On 3 months after PPV, the difference of CEC between two groups were statistically significant (t=2.276,P＜0.05); the difference of hexagon rate between two groups were not statistically significant (t=1.473,P=0.889). Conclusion The efficacy of 27G PPV for IMEM appears similar to 25G PPV. But 27G PPV has a shorter operating time for vitrectomy, a more stable IOP and a minimal damage to CEC.
The rapid advancement of causal inference is driving a paradigm shift across various disciplines. "Target trial emulation" has emerged as an exceptionally promising framework for observational real-world studies, attracting substantial attention from medical scholars and regulatory agencies worldwide. This article aims to provide an introduction to CERBOT, an online tool that assists in implementing target trial emulation studies, while highlighting the advancements in this domain. Additionally, the article provides an illustrative example to elucidate the operational process of CERBOT. The objectives are to support domestic researchers in conducting target trial emulation studies and enhance the quality of real-world studies in the domestic medical field, as well as improve the medical service level in clinical practice.