Fungal RetinitisNCT04947592
SD-OCT Guided Treatment of Fungal Chorioretinitis
An observational study of Fungal Retinitis, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Retinitis
- What is being tested?
- Fluconazole 150 mg
- How many people
- 10 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Jan 2020to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: at least 18 years old patient with fungal chorioretinitis
Who may be able to join
- fungal chorioretinitis
Who cannot join
- vitritis
- other macular lesion
- macular scar
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK R ELHAMAKY, MD
About this study
Official title: Outcome of SD-OCT Guided Oral Anti-fungal Treatment of Fungal Chorioretinitis
Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment
Read the detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days
- Conditions
- Fungal Retinitis
- Being tested
- Fluconazole 150 mg
- Keywords
- fungal, chorioretinitis, OCT
- Medical subject headings
- Chorioretinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole 150 mgDrug
fluconazole 150 MG once daily for 14 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
Measured: 6 months
Secondary outcomes (1)
optical coherence tomography (OCT) foveal thickness
change in foveal thickness measured in micrometer
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 posted1 Jul 2021
- Study start15 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal RetinitisStudies of the same condition, open and under way.
- More trials run by Benha 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-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
- Investigators
- TAREK ELHAMAKY, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947592
- Sponsor's protocol ID
- Hamaky13
- Status last verified
- Dec 2021
- First submitted
- 24 Jun 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of SD-OCT Guided Oral Anti-fungal Treatment of Fungal Chorioretinitis
- ClinicalTrials.gov ID
- NCT04947592
- Acronym / sponsor ID
- Hamaky13
- Conditions
- Fungal Retinitis
- Keywords
- fungal, chorioretinitis, OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 1 Jul 2021 (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.
Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment
Detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 18 years old patient with fungal chorioretinitis
Key inclusion criteria (1 listed)
- fungal chorioretinitis
Key exclusion criteria (3 listed)
- vitritis
- other macular lesion
- macular scar
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 |
|---|---|---|
| Fluconazole 150 mgfluconazole 150 MG once daily for 14 days | Drug | – |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 6 months
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
1 secondary outcome
optical coherence tomography (OCT) foveal thickness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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.
TAREK ELHAMAKY principal investigator
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 Fungal Retinitis, run by Benha University at 1 site in United Arab Emirates.
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 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 15 Dec 2021. 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 United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAREK R ELHAMAKY, MD (0503207889, thamaky@ibnnafees.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) (time frame: 6 months). 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 15 Dec 2021.