Corneal DiseaseNCT04267991
Corneal Densitometry Changes With Adenoviral SEI
An observational study of Corneal Disease, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Disease
- What is being tested?
- Tacrolimus ointment and phototherapeutic keratectomy
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Apr 2018to 15 Apr 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 60 patients with adenoviral SEI
Who may be able to join
- adenoviral SEI
Who cannot join
- Other corneal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates
Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.
Read the detailed description
first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.
- Conditions
- Corneal Disease
- Being tested
- Tacrolimus ointment, phototherapeutic keratectomy
- Keywords
- adenoviral, infiltrates, PTK, tacrolimus
- Medical subject headings
- Corneal Diseases, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
Also called Protopic ointment
Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.
phototherapeutic keratectomyProcedure or surgery
Patients underwent transepithelial PTK for subepithelial infiltrates.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months. Receives: Drug: Tacrolimus ointment | |
| Phototherapeutic Keratectomy | Patients underwent transepithelial PTK for subepithelial infiltrates. Receives: Procedure: phototherapeutic keratectomy | |
| Control | patients received only artificial tears eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of corneal densitometry
Sub epithelial infiltrates was examined with the densitometry programme of the Pentacam (Fa. Oculus,Weimar, Germany)
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 posted13 Feb 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion15 Apr 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 Corneal DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
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 R ELHAMAKY, Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267991
- Sponsor's protocol ID
- Hamaky5
- Status last verified
- May 2020
- First submitted
- 11 Feb 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Elhamaky TR. Pentacam corneal densitometry-guided treatment of adenoviral corneal subepithelial infiltrates: a comparative study between transepithelial phototherapeutic keratectomy and topical tacrolimus. Int Ophthalmol. 2021 Jan;41(1):67-77. doi: 10.1007/s10792-020-01553-8. Epub 2020 Aug 27.
PubMed 32852646
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Densitometry Changes With Adenoviral Keratoconjunctivitis Sub Epithelial Infiltrates
- ClinicalTrials.gov ID
- NCT04267991
- Acronym / sponsor ID
- Hamaky5
- Conditions
- Corneal Disease
- Keywords
- adenoviral, infiltrates, PTK, tacrolimus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 13 Feb 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.
Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.
Detailed description
first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | – | Drug: Tacrolimus ointmentPatients were treated with 0.03 % tacrolimus ointment twice daily for 6 months. |
| Phototherapeutic Keratectomy | – | Procedure: phototherapeutic keratectomyPatients underwent transepithelial PTK for subepithelial infiltrates. |
| Control | – | –patients received only artificial tears eyedrop |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 60 patients with adenoviral SEI
Key inclusion criteria (1 listed)
- adenoviral SEI
Key exclusion criteria (1 listed)
- Other corneal diseases
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 |
|---|---|---|
| Tacrolimus ointmentAlso: Protopic ointmentPatients were treated with 0.03 % tacrolimus ointment twice daily for 6 months. | Drug | Tacrolimus |
| phototherapeutic keratectomyPatients underwent transepithelial PTK for subepithelial infiltrates. | Procedure or surgery | Phototherapeutic Keratectomy |
Primary outcome
changes of corneal densitometry
Time frame: 6 months
Sub epithelial infiltrates was examined with the densitometry programme of the Pentacam (Fa. Oculus,Weimar, Germany)
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 29 May 2020.
- Derived from this study: PubMed 32852646Elhamaky TR. Pentacam corneal densitometry-guided treatment of adenoviral corneal subepithelial infiltrates: a comparative study between transepithelial phototherapeutic keratectomy and topical tacrolimus. Int Ophthalmol. 2021 Jan;41(1):67-77. doi: 10.1007/s10792-020-01553-8. Epub 2020 Aug 27.
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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.
TAREK R ELHAMAKY principal investigator
Benha university faculty of medicine
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 Corneal Disease, 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 1 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 29 May 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 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?
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?
changes of corneal densitometry (time frame: 6 months). 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 NCT04267991, 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 29 May 2020.