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OpenTrials
Completed

NCT Number: NCT05771467

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aslı Çentinkaya Yaprak, Antalya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive ophthalmologic examination

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)

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

Primary outcomes

  1. Corneal Thickness

    Time frame: 10 minutes

    Corneal thickness in mikrometer value

  2. Anterior Chamber Volume

    Time frame: 10 minutes

    Anterior chamber volume in mm3

  3. Anterior Chamber Depth

    Time frame: 10 minutes

    Anterior chamber depth in mm

  4. Anterior Chamber Angle

    Time frame: 10 minutes

    Anterior chamber angle in degree

  5. Lens Power

    Time frame: 10 minutes

    in diopters

  6. Steep Keratometry

    Time frame: 10 minutes

    in Diopters measured with pentacam

  7. Tonometry

    Time frame: 10 minutes

    Intraocular pressure measurement in mmHg

  8. Axial Length

    Time frame: 10 minutes

    Axial length in mm

  9. Optic Nerve Head Vessel Density

    Time frame: 10 minutes

    Optic nerve head vessel density assessed with optical coherence tomography angiography

  10. Choriocapillaris Flow Area

    Time frame: 10 minutes

    Choriocapillaris flow area assessed with optical coherence tomography angiography

  11. Subfoveal Central Macular Thickness

    Time frame: 10 minutes

    Subfoveal central macular thickness assessed with optical coherence tomography

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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