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Microaneurysm formation rate as a predictive marker for progression to clinically significant macular edema in
Christos Haritoglou1, Marcus Kernt, Aljoscha Neubauer
1*Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany; †Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany; and ‡Critical Health SA, Coimbra, Portugal.
Purpose:
To evaluate the predictive value of microaneurysm (MA) formation rate concerning the development of clinically significant macular edema (CSME) in patients with mild-to-moderate nonproliferative diabetic retinopathy as evaluated by an automated analysis of central field fundus 30° photographs.
Methods:
Two hundred and eighty-seven eyes were included in the study. Photographs obtained at Day 0, at 6, and 12 months were analyzed using the RetmarkerDR software (Critical Health SA) in a masked manner, and the MA formation rate was documented. A threshold of a calculated MA formation rate of 2 or more was chosen to consider a patient "positive." The ability to predict CSME development was then calculated for a period of up to 5 years. HbA1c values, blood pressure, or duration of diabetes were also evaluated.
Results:
The study population consisted of 89 male and 59 female patients with a mean age of 57.6 years, a mean HbA1c of 7.8, and a mean duration of diabetes of 12.3 years. Forty-seven of 287 eyes (16.4%) developed CSME during follow-up. An increased MA formation rate of >2 MA was clearly associated with development of CSME. Using the automated analysis and a threshold of 2 or more new MA, the authors were able to identify 70.2% of the eyes that developed CSME during follow-up ("true positive") and using a threshold of up to 2 new MA, 71.7% of the patients that did not develop CSME ("true negative"). No significant differences concerning baseline and 1-year HbA1c levels within patient eyes that developed CSME compared with patient eyes below or over the calculated threshold of 2 MA (P = 0.554 and P = 0.890, respectively) were seen. The positive and negative predictive value was calculated to be 33% versus 92.5%, sensitivity was 70%, and specificity was 72%.
Conclusion:
Using the RetmarkerDR software, the authors were able to identify patients with higher risk to develop CSME during follow-up using a threshold of 2 or more MA formation rate. Together with the high negative predictive value, the automated analysis may help to determine the individual risk of a patient to develop sight-threatening complications related to diabetic retinopathy and schedule individual screening intervals.
Insights
Automated analysis of microaneurysm (MA) formation rate can predict clinically significant macular edema (CSME) in diabetic retinopathy patients. A rate of 2 or more new MAs identifies high-risk individuals, aiding personalized screening for diabetic eye disease.
Area of Science:
- Ophthalmology
- Diabetic Retinopathy Research
- Medical Imaging Analysis
Background:
- Diabetic retinopathy (DR) is a leading cause of vision loss.
- Clinically significant macular edema (CSME) is a major complication of DR.
- Early detection and risk stratification are crucial for managing DR.
Purpose of the Study:
- To assess the predictive capability of microaneurysm (MA) formation rate for CSME development.
- To evaluate an automated fundus photograph analysis for this prediction.
- To correlate MA formation rate with CSME in mild-to-moderate nonproliferative diabetic retinopathy.
Main Methods:
- Retrospective analysis of 287 eyes with mild-to-moderate nonproliferative diabetic retinopathy.
- Automated analysis of central field fundus photographs (30°) using RetmarkerDR software.
- Calculation of MA formation rate over 12 months and prediction of CSME development up to 5 years.
Main Results:
- An MA formation rate of ≥2 MAs was significantly associated with CSME development.
- The automated analysis achieved 70.2% sensitivity and 71.7% specificity in predicting CSME.
- Positive predictive value was 33%, and negative predictive value was 92.5%.
Conclusions:
- Automated MA formation rate analysis using RetmarkerDR software can identify patients at higher risk for CSME.
- The high negative predictive value supports its use in risk stratification.
- This tool may enable personalized screening intervals for diabetic retinopathy complications.
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