Factors Affecting Prognosis of Open Globe Injuries

NCT ID: NCT05663814

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

: 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 :-

1. For healing.
2. Suture status.
3. Detailed slit lamp and fundus examination.
4. UCVA
5. BCVA
6. Investigations including:- B scan if hazy media OCT if clear media
7. 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Open Globe Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age + 6
2. Laceration, incised injury ,Penetrating and perforating injuries
3. Rupture globe

Exclusion Criteria

1. age less than 6
2. patients unwilling to participate in study
3. patients with disorganized globes
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ali Natag Riad

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kamel Soliman, Prof

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Natag

Role: CONTACT

Phone: 00201115872699

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36007553 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Open globe injuries

Identifier Type: -

Identifier Source: org_study_id