Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma Group | Non-trauma eye after open globe injury determine retinal microvascular changes |
| |
| Control Group | Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Thickness | Corneal thickness in mikrometer value | 10 minutes |
| Anterior Chamber Volume | Anterior chamber volume in mm3 | 10 minutes |
| Anterior Chamber Depth | Anterior chamber depth in mm | 10 minutes |
| Anterior Chamber Angle | Anterior chamber angle in degree | 10 minutes |
| Lens Power | in diopters | 10 minutes |
| Steep Keratometry | in Diopters measured with pentacam | 10 minutes |
| Tonometry | Intraocular pressure measurement in mmHg | 10 minutes |
| Axial Length | Axial length in mm | 10 minutes |
| Optic Nerve Head Vessel Density | Optic nerve head vessel density assessed with optical coherence tomography angiography | 10 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Middle age, predominantly male
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yusuf Samet Atlıhan, MD, 1 | Akdeniz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aslı Çentinkaya Yaprak | Antalya | 070059 | Turkey (Türkiye) | |||
| Yusuf Samet Atlıhan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
older 18 years
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Thickness | Corneal thickness in mikrometer value | Posted | Mean | Standard Deviation | microns | 10 minutes |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aslı Cetinkaya Yaprak | AkdenizU | +0905069228431 | ysf20smt@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2023 | Nov 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2023 | Nov 27, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
|
|
| Choriocapillaris Flow Area | Choriocapillaris flow area assessed with optical coherence tomography angiography | 10 minutes |
| Subfoveal Central Macular Thickness | Subfoveal central macular thickness assessed with optical coherence tomography | 10 minutes |
| Antalya |
| 07070 |
| Turkey (Türkiye) |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Total Group | Total number of cases |
|
|
| Primary | Anterior Chamber Volume | Anterior chamber volume in mm3 | Posted | Mean | Standard Deviation | Cubic micrometre | 10 minutes |
|
|
|
| Primary | Anterior Chamber Depth | Anterior chamber depth in mm | Posted | Mean | Standard Deviation | milimeters | 10 minutes |
|
|
|
| Primary | Anterior Chamber Angle | Anterior chamber angle in degree | Posted | Mean | Standard Deviation | degree | 10 minutes |
|
|
|
| Primary | Lens Power | in diopters | Posted | Mean | Standard Deviation | diopters | 10 minutes |
|
|
|
| Primary | Steep Keratometry | in Diopters measured with pentacam | Posted | Mean | Standard Deviation | diopters | 10 minutes |
|
|
|
| Primary | Tonometry | Intraocular pressure measurement in mmHg | Posted | Mean | Standard Deviation | milimeter mercury | 10 minutes |
|
|
|
| Primary | Axial Length | Axial length in mm | Posted | Mean | Standard Deviation | milimeters | 10 minutes |
|
|
|
| Primary | Optic Nerve Head Vessel Density | Optic nerve head vessel density assessed with optical coherence tomography angiography | Posted | Mean | Standard Deviation | vessels/mm^2 | 10 minutes |
|
|
|
| Primary | Choriocapillaris Flow Area | Choriocapillaris flow area assessed with optical coherence tomography angiography | Posted | Mean | Standard Deviation | mm^2 | 10 minutes |
|
|
|
| Primary | Subfoveal Central Macular Thickness | Subfoveal central macular thickness assessed with optical coherence tomography | Posted | Mean | Standard Deviation | microns | 10 minutes |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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) | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided