Diabetes mellitus is a group of metabolic disorders characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both^[1]. Over time, chronic hyperglycemia leads to various complications, both macrovascular and microvascular^[1]. In India, diabetes has reached epidemic proportions, with an estimated 77 million adults diagnosed in 2019. This makes India the second-largest country in terms of diabetes prevalence, trailing only China^[2].

One of the most common and serious microvascular complications of diabetes is diabetic retinopathy (DR), a progressive condition that affects the blood vessels of the retina^[3]. High blood glucose levels can cause damage to the small blood vessels in the eye, leading to leakage, bleeding, and in severe cases, retinal detachment^[4]. The primary mechanism involves microangiopathy, which results from prolonged exposure to high blood glucose levels^[4]. This condition leads to the breakdown of the blood-retinal barrier, resulting in increased vascular permeability, capillary occlusion, and ischemia. Diabetic retinopathy is classified into two main stages: non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). In NPDR, small blood vessels in the retina are damaged but new abnormal blood vessels have not yet formed. This abnormal vessel growth is fragile and prone to leakage, resulting in vitreous hemorrhages and tractional retinal detachment, both of which can lead to severe vision loss if untreated^[5,6]. As the disease progresses to PDR, these abnormal blood vessels grow on the retina, increasing the risk of severe vision loss. The risk of developing diabetic retinopathy increases with the duration of diabetes and poor glycemic control^[7,8]. Early detection and appropriate management of diabetic retinopathy are crucial in preventing vision loss. Screening programs aimed at identifying DR in its early stages, particularly among high-risk populations, play a pivotal role in reducing the burden of this condition^[9].

Despite the high risk of visual impairment associated with DR, awareness levels among diabetic patients are consistently low, resulting in delayed diagnosis and treatment. Numerous studies indicate that many patients only seek ophthalmic care when their vision is significantly impaired, by which point the damage to the retina may be irreversible. This delay in diagnosis not only increases the burden on healthcare systems but also leads to preventable vision loss, particularly in economically disadvantaged populations. In India, where rural populations and underserved areas often have limited access to specialized eye care, the lack of awareness exacerbates the problem. Many patients are unaware that DR can develop without any noticeable symptoms in its early stages, reinforcing the need for regular retinal screening. Furthermore, the absence of widespread public health campaigns focused specifically on diabetic retinopathy contributes to the growing number of patients with undiagnosed or untreated DR. This study aims to address this major public health concern by investigating the prevalence of DR in known diabetic patients and assessing their level of awareness, which is essential for implementing more effective screening and prevention programs.

AIM:

To study the prevalence and awareness of diabetic retinopathy in patients with history of diabetes mellitus attending ophthalmology outpatient department.

• Study Design: A single center, hospital-based, observational cross-sectional study aimed at determining the prevalence and awareness of diabetic retinopathy among diabetic patients visiting the ophthalmology outpatient department.
• Study Settings: Department of Ophthalmology at Amaltas Institute of Medical Sciences, Dewas, MP. Patients attending the ophthalmology outpatient department who met the inclusion criteria were enrolled and assessed for diabetic retinopathy and their awareness of the condition.
• Ethical Clearance: The study protocol underwent a rigorous review process, including the assessment of the protocol, data collection forms, and informed consent forms, to ensure adherence to ethical guidelines.
• Study Duration: The total duration of the present study was 18 months,
• Primary Outcome: The prevalence of diabetic retinopathy among known diabetic patients, measured through fundus examination and categorized according to the Early Treatment Diabetic Retinopathy Study (ETDRS) scale.
• Study Participants: Participants for this study were diabetic patients attending the ophthalmology outpatient department. Eligible participants included adult diabetic patients who met the selection criteria and provided informed consent to participate in the study.
• Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients with a confirmed diagnosis of diabetes mellitus (Type 2).
3. HbA1c level of >6.5%.
4. Patients willing to provide informed consent and participate in the study.

Exclusion Criteria :

1. Pregnant women and children.
2. Patients with a history of hypertension, traumatic cataract, complicated cataract, or congenital eye diseases.
3. Patients whose fundus examination could not be performed due to media opacity.

• Sample Size: a total of 100 participants were enrolled.
• Sampling Methodology: The study employed a non-probability convenience sampling methodology, enrolling participants who met the inclusion criteria and consented to participate during their routine visit to the ophthalmology outpatient department. This approach allowed for ease of recruitment within the available timeframe. Participants were recruited from the ophthalmology outpatient department of the Amaltas Institute of Medical Sciences. The recruitment process involved initial screening by the research team to identify patients who met the eligibility criteria. Eligible participants were then approached by the Principal Investigator, who explained the study’s objectives, significance, and procedures. Patients willing to participate were then assessed further for inclusion in the study.
• Data Collection Procedure: The data collection process was systematically organized to ensure the accuracy, consistency, and completeness of data. Each participant underwent a detailed examination and assessment, covering both clinical and non-clinical aspects of the study objectives. The process included the following steps:

1. Obtaining Informed Consent: After initial eligibility screening, the Principal Investigator provided a comprehensive explanation of the study’s objectives, methodology, and participant rights to each eligible patient. Participants were given a bilingual consent form (in Hindi and English) to read, and ample time was allowed for questions.
2. Participant Interview and Questionnaire Administration: Once consent was obtained, participants were interviewed using a structured questionnaire designed to assess their knowledge and awareness of diabetic retinopathy, including its risk factors, symptoms, and potential consequences. Questions covered topics such as the frequency of eye check-ups, understanding of diabetic retinopathy’s impact on vision, and awareness of the importance of blood sugar control. The responses were recorded meticulously, and the questionnaire aimed to gauge both general awareness and specific knowledge related to diabetic retinopathy.
3. Clinical Examination:
4. Visual Acuity Testing: Each participant’s visual acuity was tested separately for the right and left eyes using Snellen’s chart. Participants were positioned at the appropriate testing distance, and visual acuity was recorded in a standardized format.
5. Slit-Lamp Biomicroscopy Examination: The anterior segment of the eye, including the cornea, iris, and lens, was examined using a slit-lamp biomicroscope. This step helped detect any anterior eye abnormalities that might affect fundus visibility or interfere with diabetic retinopathy assessment.
6. Pupil Dilation and Fundus Examination: Tropicamide drops were administered to dilate the pupils, ensuring an adequate view of the retina. After sufficient dilation, each participant underwent a comprehensive fundus examination using a direct and indirect ophthalmoscope and a +90D lens. The examination focused on identifying signs of diabetic retinopathy, including microaneurysms, hemorrhages, exudates, and neovascularization. Findings were graded based on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, classifying each case by severity, from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR).
7. Laboratory Testing for Glycemic Control: Blood samples were collected from each participant for analysis of fasting blood glucose and HbA1c levels to assess their glycemic control. HbA1c levels were recorded, with values above 6.5% indicating poor glycemic control. This laboratory data was cross-referenced with clinical findings to explore potential correlations between glycemic levels and retinopathy stages.

• Statistical Analysis: Descriptive analyses were performed to summarize demographic and clinical characteristics of the study population. Measures of central tendency (mean, median) and dispersion (standard deviation, interquartile range) were calculated for continuous variables such as age, HbA1c levels, and diabetes duration. Categorical variables, including gender and awareness levels, were summarized using frequencies and percentages. The prevalence of diabetic retinopathy was calculated as a proportion of all study participants. The various stages of diabetic retinopathy (e.g., mild, moderate, severe non-proliferative, and proliferative) were also quantified and expressed as percentages of the total sample.
• Funding: There was no external funding for this study.
• Conflict of Interest: The researchers declare no conflict of interest in the design, implementation, or interpretation of the findings of this study.

Table 1: Characteristics of Participants A total of 100 patients with Type 2 diabetes mellitus participated in the study. The majority were in the age groups of 51–60 years (35%) and 61–70 years (37%). Only 11% were aged 31–40 years, and 17% were in the 41–50 age group. Males made up 57% of the study population, while females accounted for 43%. Regarding the duration of diabetes, 31% of patients had diabetes for less than 5 years, 43% had diabetes for 5–10 years, and 26% had it for 10–15 years.

Table 2: Prevalence and Severity of Diabetic Retinopathy

Out of the 100 diabetic patients examined, 17% showed signs of diabetic retinopathy. Most patients (83%) had no retinopathy. Mild DR was present in 7% of participants, while 3% had moderate non-proliferative diabetic retinopathy (NPDR). Severe NPDR was seen in 6% of cases, and only 1% had proliferative diabetic retinopathy (PDR).

Table 3: Knowledge about Complications of Diabetes

When asked about general diabetes complications, 63% of patients had heard about them. However, only 54% were aware that diabetes can affect the eyes. Fewer patients (46%) knew about the relationship between diabetes and retinopathy.

Table 4: Knowledge about Diabetic Retinopathy and Its Complications

Awareness of diabetic retinopathy was low among participants. Only 42% of patients knew what diabetic retinopathy is. About 34% were aware of the factors that lead to this condition. Only 38% understood that high blood sugar levels can affect vision. Just 27% believed that diabetes can lead to blindness, and only 19% knew that diabetic retinopathy is a treatable condition.

Table 5: Knowledge about Prevention of Diabetic Retinopathy

There were several misconceptions regarding prevention. About 37% of participants believed that regular eye screening is not necessary if their eyes feel healthy. Only 34% agreed that good control of diabetes can help prevent diabetic retinopathy. Regarding the frequency of eye check-ups, 42% said they would only get their eyes checked when vision is affected. Only 8% had eye exams every 6 months, 22% once a year, and 28% every two years.

Most diabetic patients in this study were older adults, especially those aged above 50 years, suggesting that age may be a contributing factor in diabetic eye complications. Male patients were slightly more in number, but both genders were well represented in the sample. A significant portion of patients had diabetes for more than five years, which may increase their risk for developing diabetic retinopathy. Most patients were adherent to their medication, indicating awareness of treatment but not necessarily of complications. A large number of patients had reduced visual acuity, which may suggest early or undetected diabetic changes in the eye. The average HbA1c and blood sugar levels were above normal, indicating poor glycaemic control in the study group. Intraocular pressure readings were within normal range in most patients, suggesting that raised IOP was not a major concern in this group. Diabetic Retinopathy was present in 17% of patients, showing that a notable proportion had eye complications due to diabetes. Most cases with Diabetic Retinopathy were in early or non-proliferative stages, with only one case showing advanced proliferative changes. Awareness about general and eye-related complications of Diabetes was limited, with less than half of the participants knowing about diabetic retinopathy. Very few patients knew that Diabetic Retinopathy is treatable or that it can lead to blindness, showing poor awareness about the seriousness of the condition.

Many patients did not believe in regular eye screening unless symptoms appeared, indicating a lack of preventive approach. Patients with higher HbA1c and blood sugar levels were more likely to have Diabetic Retinopathy, suggesting poor glycaemic control as a major risk factor. Diabetic Retinopathy was more common in those with a longer duration of Diabetes, showing a clear link between disease duration and retinal damage. More severe grades of Retinopathy were seen in patients with longer Diabetes duration, indicating progression of disease over time without regular screening.

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