Eye Injury TraumaNCT05771467
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
An observational study of Eye Injury Trauma, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Injury Trauma
- What is being tested?
- Comprehensive Ophthalmologic Examination
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Mar 2024to 2 Sep 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Middle age, predominantly male
Who may be able to join
- Be over 18 years old
- Unilateral eye injury
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aslı Çentinkaya Yaprak
Antalya, 070059
Yusuf Samet Atlıhan
Antalya, 07070
About this study
Official title: Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography
The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.
Read the 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.
- Conditions
- Eye Injury Trauma
- Being tested
- Comprehensive Ophthalmologic Examination
- Keywords
- Eye Injury Trauma, Open Globe Injury, Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Ophthalmologic ExaminationDiagnostic test
Also called Optical Coherence Tomography Angiography (OCTA), Biometry, Auto refractometry, Non contact tonometry
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)
| Study group | Role | What they receive |
|---|---|---|
| Trauma Group | Non-trauma eye after open globe injury determine retinal microvascular changes Receives: Diagnostic Test: Comprehensive Ophthalmologic Examination | |
| Control Group | Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers Receives: Diagnostic Test: Comprehensive Ophthalmologic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Thickness
Corneal thickness in mikrometer value
Measured: 10 minutes
Anterior Chamber Volume
Anterior chamber volume in mm3
Measured: 10 minutes
Anterior Chamber Depth
Anterior chamber depth in mm
Measured: 10 minutes
Anterior Chamber Angle
Anterior chamber angle in degree
Measured: 10 minutes
Lens Power
in diopters
Measured: 10 minutes
Steep Keratometry
in Diopters measured with pentacam
Measured: 10 minutes
Tonometry
Intraocular pressure measurement in mmHg
Measured: 10 minutes
Axial Length
Axial length in mm
Measured: 10 minutes
Optic Nerve Head Vessel Density
Optic nerve head vessel density assessed with optical coherence tomography angiography
Measured: 10 minutes
Choriocapillaris Flow Area
Choriocapillaris flow area assessed with optical coherence tomography angiography
Measured: 10 minutes
Subfoveal Central Macular Thickness
Subfoveal central macular thickness assessed with optical coherence tomography
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start2 Mar 2024
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eye Injury TraumaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Çetinkaya Yaprak, Akdeniz University
- Investigators
- Yusuf Samet Atlıhan, MD, 1, Principal investigator, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771467
- Sponsor's protocol ID
- AKDENIZ-GOZ-001
- Status last verified
- Nov 2024
- First submitted
- 6 Mar 2023
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05771467
- Acronym / sponsor ID
- AKDENIZ-GOZ-001
- Conditions
- Eye Injury Trauma
- Keywords
- Eye Injury Trauma, Open Globe Injury, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Group | – | Diagnostic Test: Comprehensive Ophthalmologic ExaminationNon-trauma eye after open globe injury determine retinal microvascular changes |
| Control Group | – | Diagnostic Test: Comprehensive Ophthalmologic ExaminationInvestigation of retinal microvascular circulation in age- and sex-matched healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Middle age, predominantly male
Key inclusion criteria (2 listed)
- Be over 18 years old
- Unilateral eye injury
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Ophthalmologic ExaminationAlso: Optical Coherence Tomography Angiography (OCTA), Biometry, Auto refractometry, Non contact tonometryMeasurements 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) | Diagnostic test | Control Group, Trauma Group |
Primary outcome
Corneal Thickness
Time frame: 10 minutes
Corneal thickness in mikrometer value
Anterior Chamber Volume
Time frame: 10 minutes
Anterior chamber volume in mm3
Anterior Chamber Depth
Time frame: 10 minutes
Anterior chamber depth in mm
Anterior Chamber Angle
Time frame: 10 minutes
Anterior chamber angle in degree
Lens Power
Time frame: 10 minutes
in diopters
Steep Keratometry
Time frame: 10 minutes
in Diopters measured with pentacam
Tonometry
Time frame: 10 minutes
Intraocular pressure measurement in mmHg
Axial Length
Time frame: 10 minutes
Axial length in mm
Optic Nerve Head Vessel Density
Time frame: 10 minutes
Optic nerve head vessel density assessed with optical coherence tomography angiography
Choriocapillaris Flow Area
Time frame: 10 minutes
Choriocapillaris flow area assessed with optical coherence tomography angiography
Subfoveal Central Macular Thickness
Time frame: 10 minutes
Subfoveal central macular thickness assessed with optical coherence tomography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Samet Atlıhan, MD, 1 principal investigator
Akdeniz University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Injury Trauma, run by Akdeniz University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Thickness (time frame: 10 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.