Trial Outcomes & Findings for Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury (NCT NCT05771467)
NCT ID: NCT05771467
Last Updated: 2025-01-16
Results Overview
Corneal thickness in mikrometer value
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
10 minutes
Results posted on
2025-01-16
Participant Flow
Participant milestones
| Measure |
Trauma Group
Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.
|
Control Group
Age-, sex-matched healthy volunteers
All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Trauma Group
Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.
|
Control Group
Age-, sex-matched healthy volunteers
All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
Baseline characteristics by cohort
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 20.6 • n=5 Participants
|
43 years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
44 years
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
44 participants
n=5 Participants
|
47 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesCorneal thickness in mikrometer value
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
n=91 Participants
Total number of cases
|
|---|---|---|---|
|
Corneal Thickness
|
542.23 microns
Standard Deviation 27.47
|
546.16 microns
Standard Deviation 46.03
|
544.32 microns
Standard Deviation 35.3
|
PRIMARY outcome
Timeframe: 10 minutesAnterior chamber volume in mm3
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Anterior Chamber Volume
|
177.97 Cubic micrometre
Standard Deviation 28.46
|
165.9 Cubic micrometre
Standard Deviation 26.73
|
—
|
PRIMARY outcome
Timeframe: 10 minutesAnterior chamber depth in mm
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Anterior Chamber Depth
|
2.93 milimeters
Standard Deviation 0.25
|
3.05 milimeters
Standard Deviation 0.29
|
—
|
PRIMARY outcome
Timeframe: 10 minutesAnterior chamber angle in degree
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Anterior Chamber Angle
|
38.87 degree
Standard Deviation 6.42
|
37.8 degree
Standard Deviation 4.74
|
—
|
PRIMARY outcome
Timeframe: 10 minutesin diopters
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Lens Power
|
20.98 diopters
Standard Deviation 0.35
|
20.26 diopters
Standard Deviation 0.44
|
—
|
PRIMARY outcome
Timeframe: 10 minutesin Diopters measured with pentacam
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Steep Keratometry
|
44.22 diopters
Standard Deviation 1.64
|
44.57 diopters
Standard Deviation 1.82
|
—
|
PRIMARY outcome
Timeframe: 10 minutesIntraocular pressure measurement in mmHg
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Tonometry
|
14.74 milimeter mercury
Standard Deviation 0.49
|
15.78 milimeter mercury
Standard Deviation 0.35
|
—
|
PRIMARY outcome
Timeframe: 10 minutesAxial length in mm
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Axial Length
|
23.86 milimeters
Standard Deviation 0.94
|
23.36 milimeters
Standard Deviation 0.72
|
—
|
PRIMARY outcome
Timeframe: 10 minutesOptic nerve head vessel density assessed with optical coherence tomography angiography
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Optic Nerve Head Vessel Density
|
23.22 vessels/mm^2
Standard Deviation 5.2
|
25.2 vessels/mm^2
Standard Deviation 4.4
|
—
|
PRIMARY outcome
Timeframe: 10 minutesChoriocapillaris flow area assessed with optical coherence tomography angiography
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Choriocapillaris Flow Area
|
36.88 mm^2
Standard Deviation 1.52
|
36.53 mm^2
Standard Deviation 1.89
|
—
|
PRIMARY outcome
Timeframe: 10 minutesSubfoveal central macular thickness assessed with optical coherence tomography
Outcome measures
| Measure |
Trauma Group
n=44 Participants
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)
|
Control Group
n=47 Participants
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)
|
Total Group
Total number of cases
|
|---|---|---|---|
|
Subfoveal Central Macular Thickness
|
321.42 microns
Standard Deviation 24.52
|
311.57 microns
Standard Deviation 31.13
|
—
|
Adverse Events
Trauma Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place