Open Globe InjuryNCT05663814
Factors Affecting Prognosis of Open Globe Injuries
An observational study of Open Globe Injury, run by Assiut University.
Trial summary
: Detailed history should be taken from the patients ( age ,sex ,location of accident (rural or civil) , time of injury , mode of trauma, exact mechanism of injury ) Examination at baseline to determine location and extent of injury. Associated injuries e.g. cataract ,hyphema . Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Open Globe Injury
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Any patient more than 6 years presented with open globe injury
Who may be able to join
- Age + 6
- Laceration, incised injury ,Penetrating and perforating injuries
- Rupture globe
Who cannot join
- age less than 6
- patients unwilling to participate in study
- patients with disorganized globes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Factors Affecting Prognosis of Open Globe Injuries in Assiut University Hospitals
: Detailed history should be taken from the patients ( age ,sex ,location of accident (rural or civil) , time of injury , mode of trauma, exact mechanism of injury ) Examination at baseline to determine location and extent of injury. Associated injuries e.g. cataract ,hyphema . Assessment for other life threatening injuries. Exclusion of IOFB. The presenting visual acuity should be recorded in injuried and uninjuried eye. Fundus examination if possible. The pupils should be examined for RAPD (in blunt trauma searching post traumatic optic neuropathy) Slit lamp examination at presentation to detect extent of damage. {type of wound ( corneal ,scleral ,or corneoscleral ) , prolapsed uveal tissue presence of hyphema ,sublaxated or dislocated lens ,prolapsed vitreous } Investigations done before repair (e.g. CT orbit ) Time of primary repair should be recorded. Follow up visits at 1 day, 1 week, 1 month, 3 months for :-
- For healing.
- Suture status.
- Detailed slit lamp and fundus examination.
- UCVA
- BCVA
- Investigations including:- B scan if hazy media OCT if clear media
- Refraction if possible Post operative complications and 2ry interventions
Read more
Aim of study :
predict the final visual outcome of open globe injuries. Assess most common modes of trauma in open globe injuries. Assess postoperative complications and secondary intervention
Read the detailed description
Open globe injury (OGI) is defined as a full-thickness wound of the eyewall. Its global incidence rate is 3.5 per 100,000 persons per year , but the rates vary between countries and populations depending on the socio-economic status, education, and lifestyle. These injuries result in poor visual outcome and cause severe ocular morbidity and blindness. Unexpected and sudden occurrence of the injury may cause a psychosocial problem, permanent changes in quality of life, career and plans of the sufferers. These problems also affect not only the patients, but also all their family members.
Despite the improvement in instrumentation and ocular surgery techniques, and increased awareness of occupational safety, OGI patients still exhibit poor visual prognosis. And sometimes, they can not perceive the seriousness of the injury. Therefore, the estimation of visual prognosis is very beneficial in managing the expectation of patients and establishing a treatment strategy. Many factors, such as the type of injury, mechanism of injury, the location of the wound, and posterior segment involvement, have been suggested to influence the visual prognosis in OGI.
Ocular penetrating and perforating injuries (commonly referred to as open globe injuries) can result in severe vision loss or loss of the eye. Penetrating injuries by definition penetrate into the eye but not through and through--there is no exit wound. Perforating injuries have both entrance and exit wounds. Typically, to constitute one of these injuries, a full-thickness rupture of the cornea and/or sclera must be present. Open globe rupture, in contrast, refers to blunt injury of the eye causing globe collapse. This typically occurs at the limbus and near the equator behind the recti muscles insertions, where the sclera is thinnest.
- Conditions
- Open Globe Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting prognosis of open globe injuries in Assiut university hospitals
Final visual acuity in Snellen chart
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Dec 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Globe InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Natag Riad, Assiut University
- Investigators
- Kamel Soliman, Prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663814
- Sponsor's protocol ID
- Open globe injuries
- Status last verified
- Dec 2022
- First submitted
- 19 Nov 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Chang P, Abdelmalik B, Mayer Z, Shah A, Steigleman WA. Prognosis of Open Globe Injuries at a Tertiary Referral Center: The Modified Florida Ocular Trauma Score. Am J Ophthalmol. 2022 Dec;244:152-165. doi: 10.1016/j.ajo.2022.08.015. Epub 2022 Aug 23.
PubMed 36007553
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Prognosis of Open Globe Injuries in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05663814
- Acronym / sponsor ID
- Open globe injuries
- Conditions
- Open Globe Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: Detailed history should be taken from the patients ( age ,sex ,location of accident (rural or civil) , time of injury , mode of trauma, exact mechanism of injury ) Examination at baseline to determine location and extent of injury. Associated injuries e.g. cataract ,hyphema . Assessment for other life threatening injuries. Exclusion of IOFB. The presenting visual acuity should be recorded in injuried and uninjuried eye. Fundus examination if possible. The pupils should be examined for RAPD (in blunt trauma searching post traumatic optic neuropathy) Slit lamp examination at presentation to detect extent of damage. {type of wound ( corneal ,scleral ,or corneoscleral ) , prolapsed uveal tissue presence of hyphema ,sublaxated or dislocated lens ,prolapsed vitreous } Investigations done before repair (e.g. CT orbit ) Time of primary repair should be recorded. Follow up visits at 1 day, 1 week, 1 month, 3 months for :-
- For healing.
- Suture status.
- Detailed slit lamp and fundus examination.
- UCVA
- BCVA
- Investigations including:- B scan if hazy media OCT if clear media
- Refraction if possible Post operative complications and 2ry interventions
Aim of study :
predict the final visual outcome of open globe injuries. Assess most common modes of trauma in open globe injuries. Assess postoperative complications and secondary intervention
Detailed description
Open globe injury (OGI) is defined as a full-thickness wound of the eyewall. Its global incidence rate is 3.5 per 100,000 persons per year , but the rates vary between countries and populations depending on the socio-economic status, education, and lifestyle. These injuries result in poor visual outcome and cause severe ocular morbidity and blindness. Unexpected and sudden occurrence of the injury may cause a psychosocial problem, permanent changes in quality of life, career and plans of the sufferers. These problems also affect not only the patients, but also all their family members.
Despite the improvement in instrumentation and ocular surgery techniques, and increased awareness of occupational safety, OGI patients still exhibit poor visual prognosis. And sometimes, they can not perceive the seriousness of the injury. Therefore, the estimation of visual prognosis is very beneficial in managing the expectation of patients and establishing a treatment strategy. Many factors, such as the type of injury, mechanism of injury, the location of the wound, and posterior segment involvement, have been suggested to influence the visual prognosis in OGI.
Ocular penetrating and perforating injuries (commonly referred to as open globe injuries) can result in severe vision loss or loss of the eye. Penetrating injuries by definition penetrate into the eye but not through and through--there is no exit wound. Perforating injuries have both entrance and exit wounds. Typically, to constitute one of these injuries, a full-thickness rupture of the cornea and/or sclera must be present. Open globe rupture, in contrast, refers to blunt injury of the eye causing globe collapse. This typically occurs at the limbus and near the equator behind the recti muscles insertions, where the sclera is thinnest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient more than 6 years presented with open globe injury
Key inclusion criteria (3 listed)
- Age + 6
- Laceration, incised injury ,Penetrating and perforating injuries
- Rupture globe
Key exclusion criteria (3 listed)
- age less than 6
- patients unwilling to participate in study
- patients with disorganized globes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors affecting prognosis of open globe injuries in Assiut university hospitals
Time frame: 1 year
Final visual acuity in Snellen chart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 36007553Zhou Y, Chang P, Abdelmalik B, Mayer Z, Shah A, Steigleman WA. Prognosis of Open Globe Injuries at a Tertiary Referral Center: The Modified Florida Ocular Trauma Score. Am J Ophthalmol. 2022 Dec;244:152-165. doi: 10.1016/j.ajo.2022.08.015. Epub 2022 Aug 23.
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.
Kamel Soliman, Prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Open Globe Injury, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Natag (00201115872699, Mohammedali.natag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors affecting prognosis of open globe injuries in Assiut university hospitals (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663814, which also lists 1 linked publication.
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 23 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.