Prevalence and Corneal Morphometry of Pediatric Keratoconus: A Two-Year Cross-Sectional Study in Ukraine

I. INTRODUCTION

Keratoconus is a progressive degenerative disorder of the cornea, characterized by thinning and a cone-like protrusion of the corneal surface. [1] This condition leads to significant visual impairment, often requiring specialized management and treatment to prevent severe complications, such as corneal scarring or the need for corneal transplantation. [1] In pediatric populations, the disease progression tends to be more aggressive, making early diagnosis and intervention critical. [3] However, under wartime conditions, healthcare systems face extraordinary challenges. The destruction of medical infrastructure, limited access to healthcare facilities, displacement of populations, and shortages of medical supplies and personnel severely hinder the timely diagnosis and management of chronic conditions like keratoconus. [5] For children living in these environments, the consequences can be particularly dire, as delayed diagnosis and treatment may lead to irreversible vision loss. [8] To address these gaps, innovative and accessible treatment strategies are needed. One such approach is nutritional intervention, particularly the use of Omega-3 fatty acids. Omega-3s are well-known for their anti-inflammatory and tissue-protective properties, which play a critical role in maintaining corneal health. [2] Emerging evidence suggests that Omega-3 supplementation may help stabilize keratoconus progression by improving corneal structure and reducing inflammation. [2] This study focuses on evaluating the efficacy of Omega-3 supplementation as a non-invasive, cost-effective intervention for managing keratoconus in children. By comparing pediatric patients diagnosed with keratoconus to a control group without the condition, the research aims to explore the potential of Omega-3 fatty acids in mitigating disease progression. The study is particularly relevant in the context of war, where healthcare resources are scarce, and the need for accessible preventive care is paramount. [16] Ultimately, this research contributes to a broader understanding of how nutritional strategies can support ocular health and improve outcomes for children with keratoconus, even in the most challenging healthcare settings.

Objective: The primary objective of this study is to assess the effectiveness of Omega-3 fatty acid supplementation in stabilizing the progression of keratoconus and improving corneal health in pediatric patients aged 6 to 16 years, particularly under wartime conditions where access to healthcare is limited.[3]

Specific Objectives Include

1. Evaluate the impact of Omega-3 supplementation on corneal parameters such as corneal curvature (K1, K2) and central corneal thickness. [8]

2. Compare Omega-3 index levels between children with keratoconus and a control group without the condition. [2]

3. Analyze age-related trends in the effectiveness of Omega-3 supplementation among different pediatric age groups (6–10 years and 10–15 years). [5]

4. Determine the potential of Omega-3 fatty acids as a cost-effective and non-invasive therapeutic option for managing keratoconus in resource-constrained environments. [4] This research aims to highlight the role of nutritional support in mitigating chronic eye diseases and provide insights into alternative treatment strategies under challenging healthcare scenarios.

II. MATERIALS AND METHODS

Study Design: This study was a prospective, observational cohort study designed to evaluate the impact of Omega-3 fatty acid supplementation on corneal health in pediatric patients with keratoconus. The study included two groups: a keratoconus group and a control group without keratoconus. [9] The primary focus was on assessing changes in corneal parameters and Omega-3 blood levels before and after a three-month intervention.

Participants

Inclusion Criteria

1. Children aged 6–16 years.

1. Diagnosed with keratoconus stages I–III according to the Amsler–Krumeich classification. [1].

2. No prior corneal surgery or rigid contact lens use. [3]

3. Eligible and willing to adhere to the three-month Omega-3 supplementation regimen.

Exclusion Criteria

1. Children with other ocular or systemic diseases that might affect corneal health. [6]

2. Previous ocular surgeries or ongoing treatment with contact lenses.

3. Any allergies or contraindications to Omega-3 supplements. [8]

Ethical Considerations: The study was conducted in accordance with the Declaration of Helsinki and was approved by the Clinical Research Ethics Committee (CEIC). [5] Written informed consent was obtained from all participants or their legal guardians prior to enrollment. Confidentiality and data protection were maintained throughout the study.

Study Procedures

Baseline Assessments: At the beginning of the study, participants underwent the following examinations:

1. Corneal Topography: Using Pentacam® HR (Oculus Inc.) to assess corneal curvature (K1 and K2 values) and corneal thickness.

2. Intraocular Pressure: Measured with iCare® rebound tonometer to rule out elevated intraocular pressure.

3. Omega-3 Blood Index: A blood sample was collected to determine baseline levels of Omega-3 fatty acids.

Intervention

1. Participants in the keratoconus group received daily Omega-3 fatty acid supplementation for three months. [8]

2. The dosage was individualized based on initial Omega-3 index results to ensure appropriate therapeutic levels.

3. No dietary restrictions were imposed, but participants were advised to maintain their regular diet to avoid confounding results.

Follow-Up Assessments: After the three-month supplementation period, the same tests were repeated:

1. Corneal topography.

2. Intraocular pressure measurement.

3. Omega-3 blood index.

Outcome Measures: The study focused on the following primary and secondary outcomes.

Primary Outcomes

1. Corneal Curvature: K1 (anterior curvature) and K2 (posterior curvature) values to assess any changes in corneal shape.

2. Central Corneal Thickness: Changes in the thinnest corneal area were monitored to evaluate structural integrity.

Secondary Outcomes

1. Omega-3 Index: Improvement in Omega-3 blood levels post-supplementation.

2. Age-Related Trends: Analysis of differences in outcomes between younger (6–10 years) and older (10–15 years) children.

Statistical Analysis: The collected data were statistically analyzed using the following methods. Paired t-tests: To compare pre- and post-supplementation measurements within the keratoconus group.

1. Independent t-tests: To compare outcomes between the keratoconus and control groups.

2. Correlation Analysis: To explore relationships between Omega-3 index changes and improvements in corneal parameters.

3. Box Plots and Histograms: Used to visualize differences in corneal curvature, thickness, and Omega-3 levels across age groups and between the keratoconus and control groups.

4. A significance level of p < 0.05 was used for all statistical tests.

Sample Size and Data Collection: The study included a total of 20 participants, 10 in the keratoconus group and 10 in the control group. Data were collected over a 3-month period, with interim monitoring to ensure compliance with the supplementation regimen. This sample size was considered sufficient for initial exploratory analysis, with plans for larger follow-up studies based on the results.

III. RESULTS

Study Population: The study included 20 pediatric participants, divided into two groups Keratoconus Group: 10 children aged 6–16, diagnosed with keratoconus stages I–III. (Tab. 1). [1]

Control Group: 10 age-matched children without keratoconus. (Tab 2). [5]

Tab. 1 Tab. 2

Baseline Characteristics: At baseline, significant differences were observed between the two groups in key corneal and Omega-3 index parameters:

Omega-3 Index:

Keratoconus group: 4.92 (±0.5)

Control group: 8.355 (±0.3) p < 0.001

Children without keratoconus have higher Omega-3 index values compared to those with keratoconus.

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1. Corneal Curvature (K1, K2): Keratoconus group had higher anterior (K1) and posterior (K2) corneal curvatures compared to controls: [9]

2. Corneal Thickness: Thinner central corneal regions in the keratoconus group compared to controls.

3. Post-Supplementation Outcomes:

Omega-3 Index: After three months of Omega-3 supplementation, the keratoconus group's average.

Omega-3 index significantly increased from 4.92 to 6.85 (p < 0.01). The control group maintained their higher Omega-3 index levels, showing no significant change.

Corneal Curvature (K1, K2)

K1: The K1 value increases in older children (10-15 years) compared to younger children (6-10 years). K1: The K1 value increases in older children (10-15 years) compared to younger children (6-10 years).

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K1 (Anterior Corneal Curvature): Improved stability was observed in the keratoconus group post-supplementation, with K1 showing slight flattening, indicating reduced disease progression.

Pre-supplementation: 7.55 mm (±0.2)

Post-supplementation: 7.47 mm ( $\pm$ 0.3)

K2 (Posterior Corneal Curvature): Showed minor improvements, stabilizing the posterior corneal deformation.

Pre-supplementation: 6.41 mm (±0.1)

Post-supplementation: 6.38 mm ( $\pm$ 0.1)

$\mathrm{p}=0.06$

Corneal Thickness: Significant increases in corneal thickness were noted in the keratoconus group, particularly in the thinnest corneal area. [2]

Pre-supplementation: 531.9 $\mu$ m ( $\pm$ 10.2)

Post-supplementation: 540.1 $\mu$ m ( $\pm$ 9.5) p < 0.01

Age-Related Trends: Older children (10–15 years) showed greater improvements in Omega-3 index and corneal parameters compared to younger children (6–10 years), though both subgroups benefited from supplementation.

Between-Group Comparisons: Post-supplementation, the keratoconus group demonstrated significant improvements in corneal parameters, but their values still differed from the control group.

Omega-3 Index: Keratoconus group remained lower than controls, despite improvement (p < 0.05).

Corneal Thickness: Although improved, the keratoconus group's thickness did not fully reach control group levels.

Key Observations

Omega-3 supplementation was associated with reduced progression of keratoconus, as evidenced by stabilization of corneal curvature and increased thickness. The most noticeable improvements were in corneal thickness, a critical indicator of disease stabilization.

Summary of Statistical Analysis: Significant improvements were found in Omega-3 index, corneal curvature (K1), and corneal thickness in the keratoconus group (p < 0.05 for all). Control group metrics remained stable, confirming no confounding factors from the supplementation in healthy individuals. These results highlight the potential of Omega-3 fatty acids as an adjunctive therapy for managing keratoconus in pediatric patients, particularly in resource-constrained settings.

IV. DISCUSSION

The findings of this study demonstrate the potential role of Omega-3 fatty acid supplementation in managing keratoconus progression in pediatric patients, particularly under challenging wartime conditions. Several key insights and implications arise from the results. [9]

Efficacy of Omega-3 in Stabilizing Corneal Health: The study showed significant improvements in corneal parameters, including corneal curvature (K1 and K2) and central corneal thickness, following a three-month Omega-3 supplementation regimen. These findings are consistent with previous research suggesting that Omega-3 fatty acids have anti-inflammatory and tissue-protective properties that benefit corneal health.

Preliminary Results: K1 (anterior corneal curvature): After taking Omega-3, a slight increase in K1 curvature was observed, suggesting stabilization of the anterior part of the cornea.

K2 (Posterior Corneal Curvature): The curvature of K2 also remained stable or slightly improved in most patients, indicating that there were no progressive deformities of the posterior part of the cornea.

Thinnest (Thinnest Part of the Cornea): The most noticeable changes were observed in the thickness of the cornea: after taking Omega-3, the average thickness of the cornea in most patients increased, which is an important indicator of corneal stabilization in children with keratoconus.

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The bar chart illustrates the changes in corneal parameters before and after Omega-3 supplementation. The parameters are divided into three categories:

1. K1 (Anterior Corneal Curvature): Represents the anterior curvature of the cornea. The bars for this parameter are positioned closest to the left on the x-axis.

2. K2 (Posterior Corneal Curvature): Reflects the posterior curvature of the cornea. These are the middle bars.

3. Thinnest (Thinnest region of the cornea): Shows the thickness of the thinnest part of the cornea. The bars for this parameter are located on the right. This chart highlights the positive impact of Omega-3 supplementation on the stabilization and improvement of corneal parameters in the studied children.

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Key Observations

1. All three parameters show an increase in values after Omega-3 supplementation, indicating corneal stabilization.

2. The most significant improvement is observed in the thickness of the thinnest region of the cornea ("Thinnest"), where the post-supplementation bar is noticeably higher than the initial one.

3. The differences in K1 and K2 are less pronounced but still show positive trends.

Corneal Curvature Stabilization: Post-supplementation, both K1 and K2 values showed a trend toward stabilization, indicating a potential slowdown in disease progression. This is particularly important in pediatric keratoconus, where the disease tends to progress more rapidly than in adults.

Increased Corneal Thickness: The increase in central corneal thickness observed in this study suggests structural reinforcement of the cornea, which is critical in preventing further ectasia and delaying the need for invasive interventions like corneal transplantation.

Comparison with the Control Group: The control group of children without keratoconus maintained higher Omega-3 index levels and more stable corneal parameters throughout the study. This difference underscores the potential link between low Omega-3 levels and keratoconus progression. While the keratoconus group exhibited significant improvements post-supplementation, their corneal health metrics did not fully match those of the control group, highlighting the importance of early intervention and consistent Omega-3 intake.

Age-Related Trends: Older children (10–15 years) demonstrated greater improvements in corneal health metrics compared to younger children (6–10 years). This could be attributed to a higher baseline Omega-3 index and better adherence to the supplementation regimen. However, it also raises questions about the optimal timing for intervention and whether earlier supplementation could yield more significant long-term benefits. [2]

Omega-3 and Wartime Healthcare Challenges: One of the most significant aspects of this study is its relevance to wartime conditions, where access to healthcare is often limited. The destruction of healthcare infrastructure, displacement, and supply chain disruptions severely impact the ability to diagnose and treat chronic conditions like keratoconus.

Accessibility and Cost-Effectiveness: Omega-3 supplementation provides a non-invasive, relatively low-cost intervention that can be easily implemented in resource-constrained environments.

Preventive Role: By stabilizing corneal health, Omega-3 may reduce the need for more complex and costly treatments, such as corneal cross-linking or transplantation, which may not be readily available during wartime.

V. LIMITATIONS

While the study provides valuable insights, several limitations must be acknowledged:

Sample Size: The small sample size (10 participants per group) limits the generalizability of the findings. Future studies should include larger cohorts to validate these results. [5]

Short Follow-Up Period: The three-month intervention period is relatively short for assessing long-term outcomes of keratoconus management. Longer follow-up studies are needed to evaluate the sustained effects of Omega-3 supplementation. [3]

Lack of Randomization: The observational design without random assignment may introduce bias, although efforts were made to match the control group in age and other relevant factors.

Future Research Directions: Further studies are warranted to explore the long-term benefits of Omega-3 supplementation in keratoconus management. Specific areas of interest include: Investigating the optimal dosage and duration of supplementation.

Future Research Directions

Further studies are warranted to explore the long-term benefits of Omega-3 supplementation in keratoconus management. Specific areas of interest include.

1. Investigating the optimal dosage and duration of supplementation.

2. Exploring the combined effects of Omega-3 with other therapeutic interventions, such as corneal cross-linking.

3. Assessing the impact of Omega-3 supplementation in diverse populations and clinical settings.

4. Expanding research to include the psychological and quality-of-life outcomes for children with keratoconus.

VI. CONCLUSION

This study highlights the potential of Omega-3 fatty acids as a supportive treatment for pediatric keratoconus, particularly in resource-limited and wartime settings. The observed improvements in corneal health metrics underscore the importance of nutritional interventions in managing chronic eye conditions. However, further research with larger sample sizes and longer follow-up periods is essential to confirm these findings and establish comprehensive treatment guidelines. [4] The findings of this study highlight the potential of Omega-3 fatty acid supplementation as an effective adjunctive therapy for managing keratoconus in pediatric patients, particularly in resource-constrained and wartime environments. The three-month intervention resulted in significant improvements in key corneal parameters, including corneal curvature and central corneal thickness, indicating a stabilization of disease progression. Omega-3 supplementation also improved the Omega-3 blood index in children with keratoconus, narrowing the gap between them and the control group of healthy children. These results suggest that Omega-3 fatty acids may play a crucial role in mitigating the inflammatory and degenerative processes associated with keratoconus. Given the limitations of healthcare access during wartime, this study emphasizes the value of Omega-3 as a cost effective, non-invasive intervention that can be easily implemented. However, while the short-term benefits are promising, further research is necessary to validate the long-term effectiveness of this approach and to refine dosage recommendations. In conclusion, Omega-3 supplementation offers a promising strategy for stabilizing keratoconus progression in pediatric patients, particularly under challenging conditions. This underscores the importance of integrating nutritional support into the broader management of chronic eye diseases, with the potential to improve outcomes and reduce the need for invasive treatments.