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

Eye Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771467
• Other study ID #: AKDENIZ-ATLIHAN-001
• Status: Completed
• Start date: March 6, 2023
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Injuries
• Wounds and Injuries

Intervention

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)

Locations

Country	Name	City	State
Turkey	Asli Çentinkaya Yaprak	Antalya
Turkey	Yusuf Samet Atlihan	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCTA Vascular densities	optical coherence tomography angiography (OCTA)	32 weeks
Primary	Anterior chamber depth	Anterior chamber depth in mm	32 weeks
Primary	Tonometry	Intraocular pressure measurement in mmHg	32 weeks
Primary	Best corrected visual acuity assessment	Snellen and logMAR chart	32 weeks
Primary	Axial length	Axial length in mm	32 weeks