ABSTRACT
In this pilot, sham controlled randomized control trial (RCT) in patients with ischemic central retinal vein occlusion (CRVO), we studied the safety and efficacy of intravitreal injection of autologous bone marrow derived mononuclear cells and found that both patients who received stem cell injections did not develop anterior segment neovascularization at 1 year follow up. Except for some sterile inflammatory reaction in the initial follow up, no long term injection related serious adverse events (SAEs) were observed. Based on our observations we recommend a larger, multicentric study to further establish the safety and efficacy of this treatment in patients with ischemic CRVO. Purpose: To study the safety and efficacy of autologous bone marrow derived mononuclear cells injected intravitreally in patients with ischemic CRVO. Study Design: Randomized sham controlled trial. Methods: 4 cases with ischemic CRVO were recruited into the study. 2 cases were randomized into intervention group and 2 into control group. Baseline investigations included best corrected visual acuity (BCVA), intra ocular pressure (IOP), fundus fluorescein angiography (FFA), gonioscopy and optical coherence tomography (OCT). Patients in the intervention group received intravitreal injection of autologous bone marrow derived mononuclear cells (MNCs) and those in control group received sham injection. Patients were followed up over a 12-month period. Main Outcome Measures: Development of anterior segment neovascularization. Results: Both patients in the intervention group did not develop anterior segment neovascularization over a follow up period of 12 months. 1 patient in control group developed neovascularization of iris and elevated intra ocular pressure over a follow up period of 6 weeks and required trabeculectomy for control of IOP. The other patient in control group was lost follow up after 2 weeks. Conclusions: Our initial observations suggest that intravitreal injection of mononuclear cells may reduce the risk of developing anterior segment neovascularization in patients with ischemic central retinal vein occlusion. A larger, multicentric study would be valuable to gain further evidence to our preliminary observations.
ABSTRACT
Background & objectives: This study was aimed to report the occurrence of ocular graft versus host disease (oGVHD) in allogeneic haematopoietic stem cell transplantation (allo-HSCT) patients in a tertiary care hospital setting. Methods: A cross-sectional study of ocular surface of allo-HSCT patients was done. Slit lamp biomicroscopy, symptom score, tear meniscus height, fluorescein tear break-up time, Schirmer’s test I, ocular surface staining, dry eye severity, ocular surface disease index score were done. Indications for allo-HSCT, human leukocyte antigen (HLA) matching, GVHD risk factor, systemic manifestation and treatment were also noted. Results: GVHD occurred in 44.4 per cent of 54 allo-HSCT patients (mean age 26.7 ± 12 yr) included in the study. GVHD risk factors identified included female gender, relapse, older age of donor, cytomagelo virus (CMV) reactivation, and multiparous female donors. oGVHD was noted in 31.5 per cent with mean time to occurrence being 17.8 ± 21.9 months after the allo-HSCT and was observed in 89.5 per cent of chronic GVHD cases. Acute GVHD (oral and dermatological) involvement showed a significant association with GVHD in our patients (P< 0.001, 0R 23.0, CI 6.4-82.1). Chronic GVHD was observed to be associated with the occurrence of oGVHD (dry eye) (P<0.001, OR = 24.0, CI 0.02 - 0.29). Of the 34 eyes with oGHVD, dry eye of level 3 severity was seen in 16, level 2 in six, level 1 in 12 eyes. Interpretation & conclusions: GVHD occurred in 44.4 per cent of the patients studied in the present study. Acute and chronic GVHD showed a strong association with oGVHD. Dry eye disease due to chronic oGVHD was observed in 17 (31.5%) of 54 allo-HSCT patient with chronic oGVHD occurring in 17 (89.4%) of chronic GVHD cases in allo-HSCT patients. Our study on oGVHD in post allo-HSCT patients in tertiary care centre points towards the fact that ocular morbidity due to dry eye disease as a result of oGVHD is a cause for concern in these patients.