As the number of clinical trials conducted are rising in the emerging markets, there is a need to understand and implement a robust PV system, where electronically globalized, evidence based, public health oriented and regulatory compliant PV system is established. This would also improve transparency in system and ensure enhancement in safety data reporting ensuring premature and trouble-free detection of ADRs. It might result in implementing various PV boosting activities, which could yield robust patient safety data from India and emerging markets.

BACKGROUND Ocular involvement in HIV/AIDS includes various clinical presentations including both anterior and posterior segment, most of the manifestations are those of the posterior segment. The severity of these posterior segment changes increases with decreased CD4 count. Aim of the study is to look for severity of ocular manifestations in correlation with CD4 count. MATERIALS AND METHODS A cross sectional study of ocular changes in 360 cases of HIV/AIDS patients between October 2016-May 2018. All patients underwent thorough ophthalmic evaluation including BCVA, Anterior segment examination with slit lamp biomicroscopy and posterior segment examination with Indirect ophthalmoscopy, CD4 count was noted and patients were categorised based on CD4 count and correlation of severity of ocular manifestations with CD4 count done with statistical software SPSS. RESULTS Out of 360 patients, 267 were on HAART. 54.4 % were males and 45.6% females. Maximum number of patients were in the age group of 31-40 years. Ocular manifestations were present in 252(70%) patients. Most common manifestation was HIV retinopathy (18.8%) followed by dry eye (6.9%), cataract (5.5%), CMV retinitis (5.2%), choroiditis (3.6%). CMV retinitis, choroiditis and orbital cellulitis were common in patients with CD4+count<50. Severity of ocular manifestations involving posterior segment and orbital cellulitis increased with decrease in CD4 count. There was statistically significant association between severity of ocular manifestations with CD4 count (P<0.001), and vision with CD4 count (P<0.001). CONCLUSION Patients with low CD4 count are at increased risk of acquiring severe manifestations such as posterior segment changes and orbital cellulitis. Complete ocular evaluation is must in all patients with HIV/AIDS for early diagnosis and treatment of sight threatening complications.

BACKGROUND Diabetes mellitus (DM) is a global epidemic with significant morbidity. Diabetic retinopathy (DR) is a specific microvascular complication of DM which affects around 1 in 3 persons with DM. Epidemiological studies and clinical trials have shown that optimal control of blood glucose can reduce the risk of developing retinopathy and slow its progression. Diabetic Macular Oedema (DME) is a major cause for visual impairment. The aim of the study is to evaluate correlation between glycaemic indices and central foveal thickness in patients with diabetic retinopathy with macular oedema. METHODS Fifty eyes of fifty patients with moderate non-proliferative diabetic retinopathy (NPDR) were enrolled in the study. All patients underwent complete ophthalmic examinations including OCT measurements of central macular thickness (CMT). Patients also underwent FBS, PPBS and glycosylated haemoglobin level tests. The correlation between the CMT and glycaemic indices was noted and evaluated. RESULTS Out of the fifty patients, males accounted for 32 and females 18. The mean age of patients with DME was 57.31 ± 6.32 and patients without DME was 60.60 ± 4.32 (range, 40-70 years). The duration of the study was 8 months. The mean value of HbA1c was 9.07 ± 2.01 in patients with DME and without DME it was 5.58 ± 0.34 (range, 5.2-14.8). The mean central retinal thickness was 409.66 ± 127.18 μm in patients with DME and 205.13 ± 7.94 in patients without DME (range, 186-812 μm). Univariate Analysis revealed that the DME diagnosed by OCT in diabetes was not statistically significant with age (p value-0.073). Whereas it was statistically significant with HbA1c (p value-0.0001), Fasting blood sugar (p value-0.0001), post prandial blood sugar (p value-0.0001). The HbA1c level (>7%) showed a significant (p value-0.001) and positive association with macular thickness in OCT. CONCLUSIONS In patients with HbA1c of above 7% had an increased chance of macular thickness (DME) as measured by OCT, is statistically significant and in patients with poor metabolic control (FBS, PPBS) is associated with macular oedema. Good sugar control decreased the risk of diabetic macular oedema.

To study the effect of topical nepafenac in patients with diabetic retinopathy following PRP in terms of Central foveal thickness (CFT) and Best corrected visual acuity(BCVA). Materials and Methods: This is a hospital based randomized control study conducted in Minto ophthalmic hospital, Regional institute of ophthalmology and Bowring and Lady Curzon hospital, from November 2018 to May 2020. Patients with proliferative diabetic retinopathy (PDR) without macular edema were subjected to PRP after detailed clinical evaluation and were divided into test and control groups. All the patients in two groups were matched based on: age, gender, type of diabetes, HBA1C levels and duration of type II diabetes. All patients underwent three sittings of PRP with a gap of one week interval between the sittings. Nepafenac eye drops (Nevanac, Alcon Laboratories Inc, Texas, USA) were used three time a day for a month followed by two time a day for three months in the test group and moxifloxacin eye drops (placebo)(moxicip, Cipla Ltd, India) three time a day for a month followed by two times for 3 months were used in the control group following PRP. Results: The patients in both test and control group were followed up at 1,2 and 4 months after PRP completion and the changes in CFT and BCVA were recorded. There was increase in CFT on each follow up visit in both test and control group. However increase in CFT in test group was less compared to control group which is statistically significant.(p=0.0001) There was worsening of BCVA in the test group was less compared to control group which is clinically significant but statisticially insignificant. Conclusion: Using topical Nepafenac eye drops following PRP for PDR is effective in reducing central foveal thickness and preventing the corresponding worsening of BCVA.