Evaluation of the Relationship Between Periodontal Disease Severity and Retinal Layer Thickness in Patients With Diabetic Retinopathy Using Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Optical Coherence Tomography (OCT) Measurement
研究概览
简要总结
The aim of this observational study is to investigate the relationship between periodontal disease severity and retinal layer thickness in patients diagnosed with diabetic retinopathy (DR), using optical coherence tomography (OCT) for assessment.
The main question this study seeks to answer is:
Do measurable changes in retinal layer thickness occur as periodontal disease severity increases in patients with diabetic retinopathy?
Participants will include adult individuals with a confirmed clinical diagnosis of DR. Periodontal status will be assessed through standard clinical parameters, including plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Retinal layer thickness will be measured using high-resolution OCT and OCT angiography (OCTA) devices. The study aims to analyze potential associations between periodontal disease severity and morphological as well as vascular changes in the retina.
详细描述
This observational study will aim to evaluate the possible relationship between periodontal disease severity and retinal layer thickness in patients with diabetic retinopathy (DR). Adult individuals with a confirmed clinical diagnosis of DR will be included in the study. Periodontal health status will be assessed using standard clinical parameters such as plaque index, probing pocket depth, clinical attachment loss, and bleeding on probing. Retinal layer thickness will be measured using high-resolution imaging with optical coherence tomography (OCT). Optical coherence tomography angiography (OCTA) will be used to evaluate vascular changes. The collected data will be analyzed to determine whether periodontal disease severity is associated with possible changes in retinal morphology and vascularity. This study is expected to provide new scientific evidence on the interaction between systemic diabetic complications and oral health, as well as to highlight the importance of multidisciplinary approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 60 and over
- •Those without systemic disease (control group)
- •Patients diagnosed with diabetic retinopathy
- •Patients diagnosed with diabetes mellitus (HbA1c>6)
排除标准
- •Patients with any autoimmune disease, osteoporosis, or cancer
- •Patients taking immunosuppressive medications, oral contraceptives, or bisphosphonates
- •Pregnancy
- •Patients with acute or chronic eye diseases such as vitreoretinal, optic nerve, or choroidal vascular diseases, cataracts, glaucoma, retinal degeneration, uveitis, Behçet's disease, or scleritis
- •Patients undergoing refractive or intraocular surgery
- •Presence of active infectious disease (acute hepatitis, tuberculosis, AIDS)
- •Chronic use of medications affecting periodontal tissues (cyclosporine A, phenytoin)
- •Patients taking antioxidant supplements
结局指标
主要结局
Optical Coherence Tomography (OCT) Measurement
时间窗: Day 1
A macular thickness map (ETDRS = Early Treatment Diabetic Retinopathy Study) is examined using OCT, with the center at the fovea centralis. According to the ETDRS map, the central 1 mm represents the fovea, the surrounding 3 mm area represents the inner retinal layers, and the outermost 6 mm area represents the outer retinal layers.
Optical Coherence Tomography Angiography (OCTA) Measurement
时间窗: Day 1
OCTA is a non-invasive technique that allows the evaluation of microvascular changes at the capillary level and imaging of the retinal plexuses layer by layer.
Retinal Layer Thickness
时间窗: Day 1
Definition: Retinal thickness is the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured by optical coherence tomography (OCT). ETDRS Mapping: The macular region is divided into nine sectors based on the ETDRS grid: Central subfield: A 1 mm diameter circle centered on the fovea. Inner ring (parafoveal region): 1-3 mm diameter, divided into superior, inferior, nasal, and temporal quadrants. Outer ring (perifoveal region): 3-6 mm diameter, also divided into four quadrants.
Choroidal Thickness (CSI Reference)
时间窗: Day 1
Definition: The choroid is the vascular layer beneath the RPE. Choroidal thickness is the perpendicular distance from Bruch's membrane to the choroid-sclera interface (CSI). Measurement: Typically obtained with enhanced depth imaging OCT (EDI-OCT), mapped according to the ETDRS grid.
Ganglion Cell Layer (GCL) Thickness
时间窗: Day 1
Definition: The GCL is composed of the cell bodies of retinal ganglion cells, located between the inner plexiform layer and the retinal nerve fiber layer. Measurement: OCT can quantify GCL alone or GCL + inner plexiform layer (GCL+IPL), usually reported using the ETDRS 9-sector mapping.
Retinal Nerve Fiber Layer (RNFL) Thickness
时间窗: Day 1
Definition: The RNFL consists of the unmyelinated axons of ganglion cells, located at the innermost surface of the retina. Measurement: Often assessed in the peripapillary region or in the macular area using ETDRS mapping.
Choroid-Sclera Interface (CSI)
时间窗: Day 1
Definition: The CSI is the outer anatomical boundary of the choroid where it transitions into the sclera. Role in Thickness Measurement: Serves as the lower reference point for choroidal thickness measurements (Bruch's membrane to CSI), which can be mapped according to the ETDRS grid.
Superficial Retinal Layers
时间窗: Day 1
Definition: The inner portion of the retina, located closer to the vitreous side. Typically associated with the superficial capillary plexus. These layers are among the first affected in diseases such as glaucoma, optic neuropathies, and ischemic retinopathies.
Deep Retinal Layers
时间窗: Day 1
Definition: The middle and outer portions of the retina, located closer to the photoreceptors. Associated with the deep capillary plexus. Clinical relevance: Important changes are observed here in conditions such as macular edema, diabetic retinopathy, and age-related macular degeneration.
Foveal Avascular Zone (FAZ)
时间窗: Day 1
Definition: A circular area at the center of the fovea devoid of retinal capillary vessels. Location: In the central fovea, approximately 500-600 micrometers in diameter. Characteristics: Contains the highest density of photoreceptors (especially cones). Avascular nature means nutrition is supplied via diffusion from the choroid. Responsible for the highest visual acuity. Clinical relevance: FAZ size, measurable by OCT angiography (OCTA), is an important biomarker in diabetic retinopathy, retinal vein occlusion, and macular ischemia.
次要结局
- Clinical Periodontal Parameters (Plaque Index)(Day 1)
- Clinical Periodontal Parameters (Gingival Index)(Day 1)
- Periodontal Clinical Parametres (Bleeding on Probing Index)(Day 1)
- Periodontal Clinical Parametres (Probing Pocket Depth)(Day 1)
- Periodontal Clinical Parametres (Clinical Attachment Loss)(Day 1)
研究者
Dilek KARADOĞAN
Assoc. Prof. Dr.
Recep Tayyip Erdogan University Training and Research Hospital
