Traumatic CataractNCT04630509
Epidemiology and Outcome of Pediatric Traumatic Cataract
An observational study of Traumatic Cataract, run by Assiut University at 1 site in Egypt.
Trial summary
this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Traumatic Cataract
- What is being tested?
- traumatic cataract extraction
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Aug 2020
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children admitted for traumatic cataract surgery at Assiut university hospital
Who may be able to join
- All children who have undergone traumatic cataract surgery at Assiut university over 1 year period.
Who cannot join
- children with posterior segment injury.
- children who did not complete at least 6 months of postoperative follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study
this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.
Read the detailed description
Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation.
Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome.
Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.
- Conditions
- Traumatic Cataract
- Being tested
- traumatic cataract extraction
- Keywords
- pediatric ocular trauma, Posterior chamber intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traumatic cataract extractionProcedure or surgery
Irrigation/aspiration of traumatic cataract in children with posterior chamber intraocular lens implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications
Measured: 6 months
Mechanism of injury
Blunt or penetrating eye injury
Measured: 6 months
Visual outcome
Visual acuity according to Snellen chart and LogMAR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2020
- Study completion31 Aug 2020
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 Traumatic CataractStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed M. A. Kedwany, Assiut University
- Investigators
- Salma Kedwany, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630509
- Sponsor's protocol ID
- Pediatric traumatic cataract
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to report the demographics and outcomes of pediatric traumatic cataract in upper Egypt
Publications
Kedwany SM, Saleh MGA, Tohamy D, Mostafa MM. Outcome of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study. Clin Ophthalmol. 2021 Apr 16;15:1583-1589. doi: 10.2147/OPTH.S282080. eCollection 2021.
PubMed 33888974
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study
- ClinicalTrials.gov ID
- NCT04630509
- Acronym / sponsor ID
- Pediatric traumatic cataract
- Conditions
- Traumatic Cataract
- Keywords
- pediatric ocular trauma, Posterior chamber intraocular lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Nov 2020 (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.
this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.
Detailed description
Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation.
Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome.
Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children admitted for traumatic cataract surgery at Assiut university hospital
Key inclusion criteria (1 listed)
- All children who have undergone traumatic cataract surgery at Assiut university over 1 year period.
Key exclusion criteria (2 listed)
- children with posterior segment injury.
- children who did not complete at least 6 months of postoperative follow-up.
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 |
|---|---|---|
| traumatic cataract extractionIrrigation/aspiration of traumatic cataract in children with posterior chamber intraocular lens implantation | Procedure or surgery | – |
Primary outcome
Demographics
Time frame: 6 months
Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications
Mechanism of injury
Time frame: 6 months
Blunt or penetrating eye injury
Visual outcome
Time frame: 6 months
Visual acuity according to Snellen chart and LogMAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 33888974Kedwany SM, Saleh MGA, Tohamy D, Mostafa MM. Outcome of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study. Clin Ophthalmol. 2021 Apr 16;15:1583-1589. doi: 10.2147/OPTH.S282080. eCollection 2021.
- Individual participant dataSharing planned: No. to report the demographics and outcomes of pediatric traumatic cataract in upper Egypt
Related trials for Traumatic Cataract
Active, not recruitingObservational study
Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
Traumatic Cataract
RecruitingObservational study
Shanghai Pediatric Cataract Study
Pediatric Cataract, Congenital Cataract
RecruitingObservational study
The Cohort Study of Pediatric Cataract
Pediatric Cataract
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.
Salma Kedwany, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Cataract, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demographics (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04630509, 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 16 Nov 2020.