EndophthalmitisNCT05249413
Early Vitrectomy for Endophthalmitis After Cataract Surgery
An observational study of Endophthalmitis and Cataract, run by Benha University at 1 site in Egypt.
Trial summary
Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan… Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Endophthalmitis, Cataract, Vitreous Detachment
- What is being tested?
- Early 23-gauge pars-plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2015to 15 Jan 2022
- 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that were diagnosed as acute post-operative endophthalmitis at ophthalmology department, Benha University Hospital, EGYPT.
Who may be able to join
- Acute onset endophthalmitis within 6 weeks after primary cataract surgeries.
- Patients had undergone early pars-plana vitrectomy within 48 hours of their confirmed diagnosis.
Who cannot join
- Patients were diagnosed as endogenous or chronic endophthalmitis.
- Patients with a previous history of rupture globe surgery or trauma.
- Patients who didn't complete the follow up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Early Vitrectomy for Endophthalmitis After Cataract Surgery in Delta Population, Egypt, 2015-2020.
Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan ultrasonography.
Read the detailed description
There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be preserved for cases with only light perception. The advances in posterior segment machines and small gauge cannulas decrease the incidence of intra-operative complications and encourage for early intervention in cases with endophthalmitis after primary cataract surgery.
- Conditions
- Endophthalmitis, Cataract, Vitreous Detachment, Retinal Detachment
- Being tested
- Early 23-gauge pars-plana vitrectomy
- Keywords
- endophthalmitis, cataract, vitrectomy, retinal detachment
- Medical subject headings
- Endophthalmitis, Cataract, Vitreous Detachment, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early 23-gauge pars-plana vitrectomyProcedure or surgery
pars-plana vitrectomy for management of acute post-operative endophthalmitis.
| Study group | Role | What they receive |
|---|---|---|
| Endophthalmitis after primary cataract surgery. | Cases diagnosed as acute post-operative endophthalmitis after primary cataract surgery. Receives: Procedure: Early 23-gauge pars-plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Changes in visual acuity from baseline and after early vitrectomy operation.
Measured: Baseline and 3 months after intervention.
Secondary outcomes (1)
Other prognostic factors
Other factors that may influence the final visual outcome in cases with endophthalmitis as (intraocular tamponade, posterior vitreous detachment, systemic condition and virulence of causative organism)
Measured: Baseline and 3 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start2 Jan 2015
- Primary completion30 Dec 2020
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Abdelshafy, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249413
- Sponsor's protocol ID
- RC-14-2-02
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Vitrectomy for Endophthalmitis After Cataract Surgery in Delta Population, Egypt, 2015-2020.
- ClinicalTrials.gov ID
- NCT05249413
- Acronym / sponsor ID
- RC-14-2-02
- Conditions
- Endophthalmitis, Cataract, Vitreous Detachment, Retinal Detachment
- Keywords
- endophthalmitis, cataract, vitrectomy, retinal detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 21 Feb 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.
Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan ultrasonography.
Detailed description
There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be preserved for cases with only light perception. The advances in posterior segment machines and small gauge cannulas decrease the incidence of intra-operative complications and encourage for early intervention in cases with endophthalmitis after primary cataract surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endophthalmitis after primary cataract surgery. | – | Procedure: Early 23-gauge pars-plana vitrectomyCases diagnosed as acute post-operative endophthalmitis after primary cataract surgery. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that were diagnosed as acute post-operative endophthalmitis at ophthalmology department, Benha University Hospital, EGYPT.
Key inclusion criteria (2 listed)
- Acute onset endophthalmitis within 6 weeks after primary cataract surgeries.
- Patients had undergone early pars-plana vitrectomy within 48 hours of their confirmed diagnosis.
Key exclusion criteria (3 listed)
- Patients were diagnosed as endogenous or chronic endophthalmitis.
- Patients with a previous history of rupture globe surgery or trauma.
- Patients who didn't complete the follow up period.
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 |
|---|---|---|
| Early 23-gauge pars-plana vitrectomypars-plana vitrectomy for management of acute post-operative endophthalmitis. | Procedure or surgery | Endophthalmitis after primary cataract surgery. |
Primary outcome
Best-corrected visual acuity
Time frame: Baseline and 3 months after intervention.
Changes in visual acuity from baseline and after early vitrectomy operation.
1 secondary outcome
Other prognostic factors
Time frame: Baseline and 3 months after intervention.
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 21 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A Abdelshafy, MD study chair
Benha 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 Endophthalmitis and Cataract, run by Benha 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 2 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: finished, as of the sponsor's last update on 21 Feb 2022. 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?
Best-corrected visual acuity (time frame: Baseline and 3 months after intervention.). 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 21 Feb 2022.