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

Completed

• Conditions: Eye Injury Trauma
• Interventions: Other: Optical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry

• Registration Number: NCT05771467
• Lead Sponsor: Akdeniz University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Results First Submitted: 2023-12-01
• Study Start: 2024-03-02
• Primary Completion: 2024-09-02
• Study Completion: 2024-09-02
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Results First Posted: 2025-01-16
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Yusuf Samet Atlıhan; 🇹🇷 Antalya, Turkey

Aslı Çentinkaya Yaprak; 🇹🇷 Antalya, Turkey