Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury

Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography

The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.

Study Overview

• Status: Completed
• Conditions: Eye Injury Trauma
• Intervention / Treatment: Diagnostic test: Comprehensive Ophthalmologic Examination

Detailed Description

Globe injuries can be classified as either closed- or open-globe injuries, based on the integrity of the sclera and cornea. Open-globe injury (OGI) is characterized by a full-thickness wound of the ocular wall.

As one of the most severe forms of ocular trauma, open-globe injury (OGI) causes significant vision loss. Timely and meticulous repair of these injuries can improve patient outcomes.

OGI by rupture often occurs at the weakest point of the eye wall, which may or may not be at the actual injury site. The rupture site is most commonly found in the sclera concentric to the limbus, just posterior to the insertion of the extraocular muscles.

After trauma, changes may occur in the non-trauma eye. Retinal and choroidal circulation may change as a result of adaptation mechanisms. In this study, we evaluated the vascular densities of the control group and post-traumatic non-trauma eye.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 070059
    • Aslı Çentinkaya Yaprak
  • Antalya, Turkey, 07070
    • Yusuf Samet Atlıhan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Middle age, predominantly male

Description

Inclusion Criteria:

• Be over 18 years old
• Unilateral eye injury

Exclusion Criteria:

• Be under the age of 18
• Usage of systemic drugs or topical ocular drops
• Bilateral eye injury
• Having systemic disease, having ocular pathology that may decrease visual acuity

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trauma Group; Non-trauma eye after open globe injury determine retinal microvascular changes	Diagnostic test: Comprehensive Ophthalmologic Examination; Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA); Other Names: Biometry; Auto refractometry; Non contact tonometry; Optical Coherence Tomography Angiography (OCTA)
Control Group; Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers	Diagnostic test: Comprehensive Ophthalmologic Examination; Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA); Other Names: Biometry; Auto refractometry; Non contact tonometry; Optical Coherence Tomography Angiography (OCTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Thickness	Corneal thickness in mikrometer value	10 minutes
Anterior Chamber Volume	Anterior chamber volume in mm3	10 minutes
Anterior Chamber Depth	Anterior chamber depth in mm	10 minutes
Anterior Chamber Angle	Anterior chamber angle in degree	10 minutes
Lens Power	in diopters	10 minutes
Steep Keratometry	in Diopters measured with pentacam	10 minutes
Tonometry	Intraocular pressure measurement in mmHg	10 minutes
Axial Length	Axial length in mm	10 minutes
Optic Nerve Head Vessel Density	Optic nerve head vessel density assessed with optical coherence tomography angiography	10 minutes
Choriocapillaris Flow Area	Choriocapillaris flow area assessed with optical coherence tomography angiography	10 minutes
Subfoveal Central Macular Thickness	Subfoveal central macular thickness assessed with optical coherence tomography	10 minutes

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Yusuf Samet Atlıhan, MD, 1, Akdeniz University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2024
• Primary Completion (Actual): September 2, 2024
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Eye Injury Trauma; Open Globe Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Wounds and Injuries; Eye Injuries
• Other Study ID Numbers: AKDENIZ-GOZ-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No