Knowledge and awareness of clinical trials among trial participants in India: A multicentric questionnaire-based cross-sectional study.

PURPOSE: The knowledge and attitude of participants toward clinical trials (CTs) are a key determinant in successful recruitment and retention. This study aimed to evaluate knowledge and awareness-attitude among the recruited CT participants about CTs. METHODS: This was a cross-sectional face-to-face survey comprising CT participants involved in the past or currently a part of a CT during this study within the Indian Ophthalmology Clinical Trial Network (IOCTN). A previously validated questionnaire was used, and data regarding demographics, knowledge, and awareness-attitude about CTs were collected. The total awareness-attitude score was used to determine the knowledge and awareness of the participants. RESULTS: A total of 121 subjects had participated in the study who were part of ongoing trials, of which only five participants had prior experience of CTs. The majority (90%) had knowledge about CTs, whereas only 7% had confirmed signing consent forms. The total awareness-attitude score significantly varied across locations (27% for the southern zone, 53% for the central zone, and 52% for the western zone), and this was negatively associated with education. The most negative attitude (38.6%) was observed regarding adequate information sharing among participants, whereas non-disruption of their routine family life (60.7%) and financial stability (67.6%) were the top most positive attitudes revealed during their participation. The participants' pre- and post-participation attitude toward CTs revealed a positive attitude. CONCLUSION: The factors influencing a participant's knowledge and attitudes toward CTs were revealed in the study. Furthermore, the need for awareness regarding benefits of CTs to the public, participant's rights, and their voluntary power were the major highlights.

Attitude and perception toward clinical trials in India among patients and patient bystanders visiting the Indian Ophthalmology Clinical Trial Network: A multi-centric, cross-sectional survey.

Purpose: Advances in patient treatment depend heavily on clinical trials (CTs). Patient volunteers for CT are tougher to recruit and retain. In order to administer CTs effectively, it is necessary to comprehend how the public views and perceives participating in them. The study assessed the perception and attitudes of patients and bystanders toward CTs in India. Methods: This was a multi-centric, cross-sectional study among patients and bystanders using a questionnaire that consisted of socio-demographic characteristics and questions on knowledge and attitude toward participation in CTs. The minimum sample size estimated for the survey was 750. Results: A total of 1260 respondents (patients and bystanders) had participated in the survey. 42% of total respondents were aware about CTs. Unawareness regarding (i) voluntary power of an individual to participate in a CT (only 47%), (ii) entitled benefits of free treatment and medical insurance during enrolment in a CT (only 47%), and (iii) only 16% of the respondents knew involvement of human subjects in CT were the major highlights among those who had prior knowledge about CTs. Education was the most pervasive factor in shaping positive perception among the respondents. Occupation was another ubiquitous factor in shaping their perception regarding CTs. Conclusion: The majority of respondents were not aware of CTs. The major concerns observed were time consumption and harmful nature of CTs that influenced their unwillingness to participate in CTs. Initiatives such as awareness campaigns and survey assessments that would result in scientifically effective health service policies would be strategic methods to enhance CT participation.

Knowledge and perception of health-care professionals on clinical trials in India: A pan-Indian cross-sectional survey.

Purpose: The purpose of the study was to evaluate the knowledge and perception of health-care professionals (HCPs), such as doctors/surgeons, pharmacists, nurses, optometrists, and lab technicians, on clinical trials (CTs) in India. Methods: The study was a pan-Indian cross-sectional survey initiated by the Indian Ophthalmology Clinical Trial Network (IOCTN) by using a previously validated questionnaire for three months of data collection. An online survey was used to record information regarding demographics, CT knowledge, and CT perception among HCPs. Results: A total of 630 responses were recorded from HCPs: 207 doctors and surgeons, 159 pharmacists, and 264 laboratory technicians, nurses, and optometrists across India. Over 90% of HCPs had a clear knowledge on the purpose of CTs, the informed consent (IC) process, ethical approval by the Drugs Controller General of India (DCGI). About 80% and 90% were aware of confidentiality of patients, voluntariness of participation, and good clinical practice. Surprisingly, less than 50% had lesser knowledge regarding monetary incentives of CT participants (CTPs). A slightly positive perception was observed regarding the potential benefits of CTPs, compensation related to injury, and importance of obtaining IC. Less than 50% had a negative perception that monetary compensation to CTPs led to bias and deprivation of standard treatments. However, no significant difference was observed between other aspects of demographics and perception regarding CTs. Conclusion: We observed doctors and surgeons to be having the highest regarding CTs, followed by pharmacists. The survey highlighted the necessity of scheduling awareness programs among the HCPs, which would improve their misconceptions and perception of CTs while interacting with patients for CT enrollment.

Clinicoepidemiological Profile and Treatment Outcomes in Children with Retinoblastoma: Experience from a Cancer Care Center in Northeast India.

Gaurav KumarBackground Retinoblastoma (RB) is the most common primary intraocular malignancy in children. We sought to provide a comprehensive assessment of epidemiological profile and treatment outcomes of children with RB. Methods In this retrospective study, we analyzed 189 children diagnosed with RB at our center between 2004 and 2017. Survival was analyzed with the Kaplan-Meier method and log-rank test. Results Median age at presentation was 14 months with male: female ratio 1.2:1. Mean duration between onset of symptoms and presentation was 49 days (standard deviation ± 79). Most common presenting symptom was white pupillary reflex in 60% of children. Family history of RB and other cancers was found in one (0.5%) and seven (4%) children, respectively. Primary mode of diagnosis and staging was ocular ultrasonography (bone scan) in 87% of patients. Computed tomographic scan and magnetic resonance imaging were done in 124 (66%) and 30 (16%) patients, respectively. International staging system grade E disease was found in 144 (76%), extraocular disease in 55 (29%), bilateral disease in 49 (26%), and trilateral disease in 3 (1.5%) children. Out of 189 children with RB, 33 (18%) refused treatment and 156 children received treatment (24 children [15%] abandoned treatment midway and 132 [85%] completed treatment). One hundred children (64%) received systemic therapy as neoadjuvant or adjuvant chemotherapy and 20 (13%) received local therapy. Eyeball and vision salvage rate with chemotherapy were 20 (13%) and 9 (6%), respectively. Cryotherapy was the most common modality of local treatment used in 11 (55%) children. Five-year survival for patients who received treatment was 76% (median survival not reached). In the treatment refusal group, median survival was 9 months. Conclusion In developing countries, RB is mostly detected in advanced stages resulting in poor outcomes. Increased awareness and accessibility to dedicated centers for treating childhood malignancy can lead to early diagnosis, better prognosis, and increased vision salvage.

Spectrum of Eye Disease in Diabetes (SPEED) in India: A prospective facility-based study. Report # 3. Retinal vascular occlusion in patients with type 2 diabetes mellitus.

Purpose: To determine the proportion of people with type 2 diabetes mellitus (T2DM) attending large eye care facilities across India who have retinal vascular occlusion (RVO). Methods: A 6-month descriptive, multicenter, observational hospital-based study of people was being presented to the 14 eye care facilities in India. The retina-specific component of comprehensive eye examination included stereoscopic biomicroscopy, binocular indirect ophthalmoscopy, and fundus fluorescein angiography, and optical coherence tomography was also available when needed. Data recording of the duration of diabetes, hypertension (HTN), stroke, and other variables was obtained from the medical history. The statistical analysis included frequencies, mean, and standard deviations for continuous variables. Odds ratio (OR) and multivariate analysis were undertaken to assess the associations between risk factors and RVO. Results: The study recruited 11,182 consecutive patients (22,364 eyes) with T2DM. About 59.0% (n = 6697) were male. The mean age was 58.2 ± 10.6 years. In this cohort, RVO was detected in 3.4% (n = 380) of patients; 67.6% (n = 257) of them had branch retinal vein occlusion (BRVO) and the remaining 32.4% (n = 123) had central retinal vein occlusion (CRVO). The frequency of unilateral BRVO (n = 220, 85.6%) and unilateral CRVO (n = 106, 86.18%) was much common. Unilateral RVO was more frequent (n = 326, 85.8%) than bilateral diseases (n = 54, 14.2%) (χ2 = 126.95, P < 0.001). Ischemic CRVO was more common (n = 103, 73.6%) than nonischemic CRVO (n = 37, 26.4%). Macula-involving BRVO was found in 58.5% (n = 172) of cases, suggesting more than 50% of cases in RVO carries a risk of severe vision loss. The duration of diabetes apparently had no influence on the occurrence of RVO. On the multivariate analysis, a history of HTN [OR: 1.7; 95% confidence interval (CI): 1.3-2.1; P = 0.001) and stroke (OR: 5.1; 95% CI: 2.1-12.4; P < 0.001) was associated with RVO. Conclusion: RVO is a frequent finding in people with T2DM. History of stroke carries the highest risk followed by HTN. The management of people with T2DM and RVO must also include comanagement of all associated systemic conditions.

Outbreak of Multidrug-resistant Pseudomonas Aeruginosa Endophthalmitis Due to Contaminated Trypan Blue Solution.

PURPOSE: To report the investigation of an outbreak of multidrug-resistant (MDR) Pseudomonas aeruginosa endophthalmitis in 13 patients after cataract surgery and to emphasize on the importance of clinical profile, risk factors, and treatment outcomes. METHODS: This was a hospital-based, retrospective case study with 13 consecutive patients who had man- ual small-incision cataract surgery with intraocular lens (IOL) implantation and developed acute postoperative Pseudomonas aeruginosa endophthalmitis. The anterior chamber taps, vitreous aspirates, and environ- mental surveillance specimens were inoculated for culturing. Antibiotic susceptibility testing was performed using the agar diffusion method. Pulsed-field gel electrophoresis (PFGE) was used to determine the relation- ship between bacterial isolates recovered from study patients and contaminated surveillance samples. RESULTS: Pseudomonas aeruginosa was isolated from all 13 eyes with acute postoperative endophthalmitis and the trypan blue solutions used during surgery. Sensitivity tests revealed that all isolates had an identical resistance to multiple drugs and were only susceptible to imipenem. Genomic DNA typing of Pseudomonas aeruginosa isolates recovered from patients and trypan blue solutions showed an identical banding pattern on the PFGE. Despite the prompt use of intravitreal antibiotics and early vitrectomy with IOL explantation in some patients, the outcome was poor in about 50% of patients. CONCLUSION: Positive microbiology and genomic DNA typing results proved that the contaminated trypan blue solutions were the source of infection in this outbreak. Postoperative endophthalmitis caused by Pseudomonas aeruginosa is often associated with a poor visual prognosis despite prompt treatment with intravitreal antibiotics.

Hyperacute spontaneous closure of a traumatic macular hole in a colobomatous eye.

A 12 year old boy presented to us with complaints of diminution of vision following blunt injury to his left eye. Examination revealed a grade 5 retina-choroidal coloboma in left eye with haemorrhage at its inferior border. A macular hole was seen clinically which was confirmed on ocular coherence tomography (OCT). Repeat fundus examination & OCT after 10 days revealed spontaneous closure of the macular hole with improvement in the visual acuity.

Surgical outcome in optic disc pit maculopathy.

The purpose of this study was to present the surgical outcome in optic disc pit associated maculopathy in a patient who was treated with vitrectomy, internal limiting membrane (ILM) peeling, barrage laser photocoagulation, and silicone oil tamponade. A 21-year-old Indian male was diagnosed with optic disc pit maculopathy in his left eye with a best-corrected visual acuity (BCVA) of 20/200. A 23-gauge pars plana vitrectomy with peeling of ILM was done using brilliant blue dye. After completion of vitrectomy, fluid-air exchange was performed and silicone oil was instilled into eye. Peripapillary endolaser barrage photocoagulation using two rows of low-intensity laser was performed temporally. Silicone oil was removed 4 months after surgery. During the next 24 months, the retina gradually flattened with gradual improvement of BCVA in the left eye. At 24 months, fundus examination showed retinal pigment epithelium atrophy temporal to optic disc not involving the fovea, and optical coherence tomography showed complete resolution of subretinal fluid, with a BCVA of 20/60. The patient maintained the same vision 4 years following the surgery. vitrectomy combined with posterior hyaloid and ILM peeling followed by silicone oil tamponade, with additional laser photocoagulation, was successful for the treatment of optic disc pit maculopathy in our patient. Further studies are warranted to explore the various treatment options and try to set a standard treatment protocol for this rare challenging condition.

Cyclophotocoagulation-induced sympathetic ophthalmia in a Coats' disease patient supported by histopathology and immunohistochemistry.

We describe a case of a 13-year-old male patient of Coats' disease who developed sympathetic ophthalmia (SO) following contact diode laser cyclophotocoagulation. There was no history of invasive surgery or any perforating injuries preceding cyclodestructive therapy. The eye had neovascular glaucoma secondary to Coats' disease, which was treated once with contact cyclophotocoagulation. Subsequently, the intraocular pressure slowly decreased, and the eye became phthisical. Intraocular inflammation developed in the fellow eye and SO was suspected, which was confirmed by characteristic findings seen on fluorescein angiography. The case was successfully managed with the help of topical and systemic immunosuppression. Enucleation with silicone ball implantation was performed in the right phthisical eye and specimen was sent for histopathological examination. Histopathology and immunostaining supported the diagnosis of SO.

Scleral patch grafts in the management of uveal and ocular surface tumors.

OBJECTIVE: To evaluate the outcome of scleral patch grafts in a series of patients undergoing management for uveal and ocular surface tumors. DESIGN: Case series. PARTICIPANTS: Ten patients underwent scleral patch grafting. Five patients had uveal melanoma with extrascleral extension, 2 patients had scleromalacia secondary to plaque radiotherapy for uveal melanoma, 2 patients had suspicious uveoscleral nevi, and 1 patient had invasive conjunctival squamous cell carcinoma with scleral necrosis. METHODS: Retrospective, interventional, noncomparative chart review of patients undergoing treatment for ocular tumors followed by scleral grafts in a tertiary eye care center in the United States between September 2003 and January 2011. Sclera was reconstructed with allogenic scleral grafts. Clinical observations were performed after grafting. MAIN OUTCOME MEASURES: Structural integrity, appearance, and stability of the grafts. RESULTS: Ten patients were reviewed. All melanoma cases received plaque radiotherapy with palladium 103. The cases with nevi and squamous cell carcinoma underwent local resection with cryotherapy as primary treatment. In 8 cases, scleral grafting was performed as part of the initial surgery. In all of these cases, satisfactory anatomic and functional outcomes were achieved. In 2 cases with scleromalacia secondary to radiotherapy for uveal melanoma, grafts were placed several years after the initial treatment. In these 2 cases, one showed signs of graft retraction, whereas another showed graft thinning. No patients experienced graft infection, rejection, or tumor recurrence. CONCLUSIONS: In this series, scleral grafts were well accepted when placed as part of the primary tumor management despite synchronous radiotherapy, scleral resection, or cryotherapy. Grafting was less successful when performed as a late procedure for radiation-induced scleromalacia. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.