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

NCT ID: NCT05771467

Last Updated: 2025-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-02

Study Completion Date

2024-09-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Eye Injury Trauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Trauma Group

Non-trauma eye after open globe injury determine retinal microvascular changes

Comprehensive Ophthalmologic Examination

Intervention Type DIAGNOSTIC_TEST

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)

Control Group

Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers

Comprehensive Ophthalmologic Examination

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Optical Coherence Tomography Angiography (OCTA) Biometry Auto refractometry Non contact tonometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Aslı Çetinkaya Yaprak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yusuf Samet Atlıhan, MD, 1

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Hospital

Locations

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Aslı Çentinkaya Yaprak

Antalya, , Turkey (Türkiye)

Site Status

Yusuf Samet Atlıhan

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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AKDENIZ-GOZ-001

Identifier Type: -

Identifier Source: org_study_id

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