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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05771467
Enrollment
100
Registered
2023-03-16
Start date
2024-03-02
Completion date
2024-09-02
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Injury Trauma

Keywords

Eye Injury Trauma, Open Globe Injury, Optical Coherence Tomography

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.

Interventions

DIAGNOSTIC_TESTComprehensive 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)

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Lens Power10 minutesin diopters
Steep Keratometry10 minutesin Diopters measured with pentacam
Tonometry10 minutesIntraocular pressure measurement in mmHg
Axial Length10 minutesAxial length in mm
Optic Nerve Head Vessel Density10 minutesOptic nerve head vessel density assessed with optical coherence tomography angiography
Choriocapillaris Flow Area10 minutesChoriocapillaris flow area assessed with optical coherence tomography angiography
Corneal Thickness10 minutesCorneal thickness in mikrometer value
Anterior Chamber Volume10 minutesAnterior chamber volume in mm3
Anterior Chamber Depth10 minutesAnterior chamber depth in mm
Anterior Chamber Angle10 minutesAnterior chamber angle in degree
Subfoveal Central Macular Thickness10 minutesSubfoveal central macular thickness assessed with optical coherence tomography

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Trauma Group
Non-Trauma Eye After Open-Globe Injury 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)
44
Control Group
Age-, sex-matched healthy volunteers 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)
47
Total91

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up63

Baseline characteristics

CharacteristicTotalControl GroupTrauma Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants11 Participants9 Participants
Age, Categorical
Between 18 and 65 years
71 Participants36 Participants35 Participants
Age, Continuous44 years
STANDARD_DEVIATION 19.4
43 years
STANDARD_DEVIATION 17.5
51 years
STANDARD_DEVIATION 20.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
91 Participants47 Participants44 Participants
Region of Enrollment
Turkey
91 participants47 participants44 participants
Sex: Female, Male
Female
39 Participants18 Participants21 Participants
Sex: Female, Male
Male
52 Participants29 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Anterior Chamber Angle

Anterior chamber angle in degree

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupAnterior Chamber Angle38.87 degreeStandard Deviation 6.42
Control GroupAnterior Chamber Angle37.8 degreeStandard Deviation 4.74
Primary

Anterior Chamber Depth

Anterior chamber depth in mm

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupAnterior Chamber Depth2.93 milimetersStandard Deviation 0.25
Control GroupAnterior Chamber Depth3.05 milimetersStandard Deviation 0.29
Primary

Anterior Chamber Volume

Anterior chamber volume in mm3

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupAnterior Chamber Volume177.97 Cubic micrometreStandard Deviation 28.46
Control GroupAnterior Chamber Volume165.9 Cubic micrometreStandard Deviation 26.73
Primary

Axial Length

Axial length in mm

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupAxial Length23.86 milimetersStandard Deviation 0.94
Control GroupAxial Length23.36 milimetersStandard Deviation 0.72
Primary

Choriocapillaris Flow Area

Choriocapillaris flow area assessed with optical coherence tomography angiography

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupChoriocapillaris Flow Area36.88 mm^2Standard Deviation 1.52
Control GroupChoriocapillaris Flow Area36.53 mm^2Standard Deviation 1.89
Primary

Corneal Thickness

Corneal thickness in mikrometer value

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupCorneal Thickness542.23 micronsStandard Deviation 27.47
Control GroupCorneal Thickness546.16 micronsStandard Deviation 46.03
Total GroupCorneal Thickness544.32 micronsStandard Deviation 35.3
Primary

Lens Power

in diopters

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupLens Power20.98 dioptersStandard Deviation 0.35
Control GroupLens Power20.26 dioptersStandard Deviation 0.44
Primary

Optic Nerve Head Vessel Density

Optic nerve head vessel density assessed with optical coherence tomography angiography

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupOptic Nerve Head Vessel Density23.22 vessels/mm^2Standard Deviation 5.2
Control GroupOptic Nerve Head Vessel Density25.2 vessels/mm^2Standard Deviation 4.4
Primary

Steep Keratometry

in Diopters measured with pentacam

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupSteep Keratometry44.22 dioptersStandard Deviation 1.64
Control GroupSteep Keratometry44.57 dioptersStandard Deviation 1.82
Primary

Subfoveal Central Macular Thickness

Subfoveal central macular thickness assessed with optical coherence tomography

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupSubfoveal Central Macular Thickness321.42 micronsStandard Deviation 24.52
Control GroupSubfoveal Central Macular Thickness311.57 micronsStandard Deviation 31.13
Primary

Tonometry

Intraocular pressure measurement in mmHg

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Trauma GroupTonometry14.74 milimeter mercuryStandard Deviation 0.49
Control GroupTonometry15.78 milimeter mercuryStandard Deviation 0.35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026