Factors Affecting Prognosis of Open Globe Injuries

December 15, 2022 updated by: Mohamed Ali Natag Riad, Assiut University

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 :-

  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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient more than 6 years presented with open globe injury

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors affecting prognosis of open globe injuries in Assiut university hospitals
Time Frame: 1 year
Final visual acuity in Snellen chart
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kamel Soliman, Prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 19, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Open globe injuries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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