Evaluation of Retinal Microvascular Change That May Develop in Patients After Open Globe İnjury With Optical Coherence Tomography (OCTA)

Sponsor

Akdeniz University (Other)

Overall Status

Completed

CT.gov ID

NCT05771467

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eye Injuries	Other: Optical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Retinal Microvascular Change That May Develop in Patients After Open Globe İnjury With Optical Coherence Tomography (OCTA)

Actual Study Start Date :

Mar 6, 2023

Actual Primary Completion Date :

Mar 6, 2023

Actual Study Completion Date :

Mar 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Trauma Group Non-Trauma Eye After Open-Globe Injury	Other: Optical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry 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)
Control Group Age-, sex-matched healthy volunteers	Other: Optical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry 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)

Arm

Intervention/Treatment

Trauma Group

Non-Trauma Eye After Open-Globe Injury

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

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)

Control Group

Age-, sex-matched healthy volunteers

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

Outcome Measures

Primary Outcome Measures

OCTA Vascular densities [32 weeks]
optical coherence tomography angiography (OCTA)
Anterior chamber depth [32 weeks]
Anterior chamber depth in mm
Tonometry [32 weeks]
İntraocular pressure measurement in mmHg
Best corrected visual acuity assessment [32 weeks]
Snellen and logMAR chart
Axial length [32 weeks]
Axial length in mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aslı Çentinkaya Yaprak	Antalya		Turkey	070059
2	Yusuf Samet Atlıhan	Antalya		Turkey	07070

Sponsors and Collaborators

Akdeniz University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aslı Çetinkaya Yaprak, Assistant professor, Akdeniz University

ClinicalTrials.gov Identifier:

NCT05771467

Other Study ID Numbers:

AKDENIZ-ATLIHAN-001

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 17, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aslı Çetinkaya Yaprak, Assistant professor, Akdeniz University

Eye Injuries, Optical Coherence Tomography Angiography

Additional relevant MeSH terms:

Eye Injuries

Wounds and Injuries

Study Results

No Results Posted as of Mar 17, 2023