Corneal EctasiaNCT06348368
Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder
An observational study of Corneal Ectasia, run by Sohag University at 1 site in Egypt.
Trial summary
Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- Pentacam and autorefractometry
- How many people
- 4,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Feb 2024
- 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 7 to 18 years
- All sexes
- Child, Adult
Study population: Children live in upper Egypt with high cylinder and no corneal scar.
Who may be able to join
- Upper Egypt children with high cylinder(refractive errorr).
Who cannot join
- Children below age of 7 years old (uncooperative), patients above age of 18 years old.Patients with corneal scars
Trial locations and contacts
1 site in 1 country.
About this study
Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study
Read the detailed description
Astigmatism is defined as, a refractive condition in which refractive light fails to form a focus on the retina, it accounts for about 13% of refractive errors. It is frequent and correctable cause of visual impairment in children whether associated with spherical errors or not.
Astigmatism, is the refractive error of the highest clinical importance, being associated with reduced visual acuity with subsequent development of refractive amblyopia.
High cylinder in children belong to areas of hot and dry climates, makes exclusion of keratoconus is mandatory. Population in the African continent, the Mediterranean countries, Central and South America, and the Indian subcontinent usually have the habit of eye rubbing because of bothering symptoms of dryness, itching, atopy, allergy and vernal keratoconjunctivitis, which is the severe form of allergic conjunctivitis.
Eye rubbing causes thinning of keratocyte and increases the prevalence of keratoconus.
Keratoconus in children (diagnosed before the age of eighteenth) is less common but more aggressive than that of the adults, due to the dynamic nature of the young cornea. Few studies in the literature reported the prevalence and incidence of keratoconus in children.
Pentacam is an advanced instrument with a rotating Scheimpflug camera for scanning the anterior and posterior corneal surfaces. Its measurements of the corneal thickness and posterior elevation have been proved to be of high reproducibility and repeatability.
- Conditions
- Corneal Ectasia
- Being tested
- Pentacam and autorefractometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam and autorefractometryOther
Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (control group) | Children with normal Pentacam and with no refractive errors Receives: Other: Pentacam and autorefractometry | |
| Group 2 (children with high cylinder and no corneal topographic abnormalities) | Children with high cylinder without corneal topographic ectasia. Receives: Other: Pentacam and autorefractometry | |
| Group 3 (Children with high cylinder and corneal ectatic changes). | Children with high cylinder and corneal ectatic changes Receives: Other: Pentacam and autorefractometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values anterior and posterior corneal elevation values by pentacam.
Corneal topgraphic changes in children with high cylinder in upper Egypt
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2023
- Primary completion30 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
- Investigators
- Elshimaa A.Mateen, Principal investigator, Assistant professor of ophthalmology, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348368
- Sponsor's protocol ID
- Soh-Med-23-01-29
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder
- ClinicalTrials.gov ID
- NCT06348368
- Acronym / sponsor ID
- Soh-Med-23-01-29
- Conditions
- Corneal Ectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Apr 2024 (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.
Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study
Detailed description
Astigmatism is defined as, a refractive condition in which refractive light fails to form a focus on the retina, it accounts for about 13% of refractive errors. It is frequent and correctable cause of visual impairment in children whether associated with spherical errors or not.
Astigmatism, is the refractive error of the highest clinical importance, being associated with reduced visual acuity with subsequent development of refractive amblyopia.
High cylinder in children belong to areas of hot and dry climates, makes exclusion of keratoconus is mandatory. Population in the African continent, the Mediterranean countries, Central and South America, and the Indian subcontinent usually have the habit of eye rubbing because of bothering symptoms of dryness, itching, atopy, allergy and vernal keratoconjunctivitis, which is the severe form of allergic conjunctivitis.
Eye rubbing causes thinning of keratocyte and increases the prevalence of keratoconus.
Keratoconus in children (diagnosed before the age of eighteenth) is less common but more aggressive than that of the adults, due to the dynamic nature of the young cornea. Few studies in the literature reported the prevalence and incidence of keratoconus in children.
Pentacam is an advanced instrument with a rotating Scheimpflug camera for scanning the anterior and posterior corneal surfaces. Its measurements of the corneal thickness and posterior elevation have been proved to be of high reproducibility and repeatability.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control group) | – | Other: Pentacam and autorefractometryChildren with normal Pentacam and with no refractive errors |
| Group 2 (children with high cylinder and no corneal topographic abnormalities) | – | Other: Pentacam and autorefractometryChildren with high cylinder without corneal topographic ectasia. |
| Group 3 (Children with high cylinder and corneal ectatic changes). | – | Other: Pentacam and autorefractometryChildren with high cylinder and corneal ectatic changes |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children live in upper Egypt with high cylinder and no corneal scar.
Key inclusion criteria (1 listed)
- Upper Egypt children with high cylinder(refractive errorr).
Key exclusion criteria (1 listed)
- Children below age of 7 years old (uncooperative), patients above age of 18 years old.Patients with corneal scars
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 |
|---|---|---|
| Pentacam and autorefractometryPentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children | Other | Group 1 (control group), Group 2 (children with high cylinder and no corneal topographic abnormalities), Group 3 (Children with high cylinder and corneal ectatic changes). |
Primary outcome
Values anterior and posterior corneal elevation values by pentacam.
Time frame: one year
Corneal topgraphic changes in children with high cylinder in upper Egypt
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 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Corneal Ectasia
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Corneal Elastography and Patient Specific Modeling
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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.
Elshimaa A.Mateen principal investigator
Assistant professor of ophthalmology, Sohag 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 Corneal Ectasia, run by Sohag 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 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 9 Apr 2024. 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?
Values anterior and posterior corneal elevation values by pentacam. (time frame: one year). 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 9 Apr 2024.