Optical Coherence Tomography Findings Associated With the Glaucoma-periodontitis Stage

NCT07853469 | Completed

• 1 other identifier: glaucoma2025/381
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the relationship between the stage of periodontal disease and retinal layer thicknesses in glaucoma patients using optical coherence tomography (OCT). The primary question the study seeks to answer is: Is there a relationship between the stage of periodontal disease and retinal layer thicknesses in glaucoma patients? Participants-with and without glaucoma and at various stages of periodontal disease-will undergo periodontal examinations and optical coherence tomography (OCT) assessments to evaluate retinal layer thicknesses.

Conditions

Glaucoma; GLAUCOMA 1, OPEN ANGLE, D (Disorder); Periodontitis

Keywords

periodontitis; glaucoma; optical coherence tomography; retina

Outcome Measures

Primary Outcomes (6)

• Optical Coherence Tomography (OCT) Measurement

  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.

  Day 1

• Retinal Layer Thickness

  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.

  Day 1

• Choroidal Thickness (CSI)

  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.

  Day 1

• Ganglion Cell Layer (GCL) Thickness

  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.

  Day 1

• Retinal Nerve Fiber Layer (RNFL) Thickness

  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.

  Day 1

• Choroid-Sclera Interface (CSI)

  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.

  Day 1

Secondary Outcomes (5)

• 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

Study Arms (3)

Control

Systemically healthy individuals without glaucoma

Normotensive glaucoma

Systemically healthy individuals with primary open-angle glaucoma who have normal intraocular pressure (9-21 mmHg)

Hypertensive glaucoma

Systemically healthy individuals with primary open-angle glaucoma who have high intraocular pressure (≥21 mmHg)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals over the age of 60 who apply to the Department of Ophthalmology at Recep Tayyip Erdoğan University Faculty of Medicine

You may qualify if:

• Men and women aged 60 years and older
• Systemically healthy individuals
• Patients diagnosed with primary open-angle glaucoma (POAG) according to the European Glaucoma Society (EGS) 2017 classification

You may not qualify if:

• Presence of autoimmune, osteoporotic, or malignant disease
• Chronic use of immunosuppressive drugs, oral contraceptives, or bisphosphonate therapy
• Pregnancy
• Retinal, optic nerve, or choroidal vascular diseases; cataracts, age-related macular degeneration, uveitis, Behçet's disease, or scleritis
• Previous refractive or intraocular surgery
• Active infectious diseases (e.g., tuberculosis, hepatitis, HIV/AIDS)
• Chronic use of medications that may affect periodontal tissues (e.g., cyclosporine A, phenytoin)

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Department of Ophthalmology of the Faculty of Medicine of Recep Tayyip Erdogan University

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Glaucoma; Periodontitis

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: October 6, 2025
• Primary Completion: April 6, 2026
• Study Completion: May 11, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)