KeratoconusNCT04092426
Prevelance of Keratoconus
An observational study of Keratoconus, run by Assiut University.
Trial summary
Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keratoconus
- What is being tested?
- opthalmologic examination
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with keratoconus in people attending refractive surgery
Who may be able to join
- persons attending refractive surgery centers in Asssiut.
- patients found to have keratoconus are included , based on history , clinical examination and corneal topography
Who cannot join
- patients not attending those refractive surgery centers.
- patients attending these centers but not diagnosed to be keratoconus .
- Pregnancy or breastfeeding
About this study
Official title: Prevelance of Keratoconus in Individuals Attending Refreactive Surgery Centers in Assiut
Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Patients who are at an advanced stage of ectasia are often led to corneal transplant or other treatments, which essentially aim at correcting the refractive error and not in treating the ectasia. The top of the protruding cone that corneal configuration may be close to the visual axis or below and nasal of that. The disease manifests during adolescence, followed by slow progressive course, although it is possible to stabilize anytime. In 85% of cases both eyes are affected, but the severity of the attack can present significant asymmetry.
Read the detailed description
Often in keratoconus a positive family history is present. Prevelance of keratoconus varies greatly worldwide.The reported prevalence of keratoconus varies widely depending upon the geographic location, diagnostic criteria used, and the cohort of patients selected. Environmental factors may contribute to the wide variation in prevalence.
the Middle East have higher prevalence than locations with cooler climates and less sunshine
- Conditions
- Keratoconus
- Being tested
- opthalmologic examination
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opthalmologic examinationOther
opthalmologic examination : Refraction Best corrected visual acuity Intraocular pressure Slit lamp examination
| Study group | Role | What they receive |
|---|---|---|
| patients with keratoconus | patients with keratoconus attending refractive surgery centers in Assiut will be subjected to the following :-
1. Full history and clinical evaluation.
2. collection of individual data ( residency , occupation , special habbit , chronic illness )
3. Analysis of results to assess prevelance of keratoconus and its distribution geographically in Assiut Receives: Other: opthalmologic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of keratoconus in different areas in assiut
Number of keratoconus cases detected areas in indivduals attending refractive surgery centers in Assiut
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 posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
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 KeratoconusStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam hamdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092426
- Sponsor's protocol ID
- keratoconus in assiut
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonas JB, Nangia V, Matin A, Kulkarni M, Bhojwani K. Prevalence and associations of keratoconus in rural maharashtra in central India: the central India eye and medical study. Am J Ophthalmol. 2009 Nov;148(5):760-5. doi: 10.1016/j.ajo.2009.06.024. Epub 2009 Aug 11.
PubMed 19674732
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Keratoconus in Individuals Attending Refreactive Surgery Centers in Assiut
- ClinicalTrials.gov ID
- NCT04092426
- Acronym / sponsor ID
- keratoconus in assiut
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 17 Sep 2019 (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.
Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Patients who are at an advanced stage of ectasia are often led to corneal transplant or other treatments, which essentially aim at correcting the refractive error and not in treating the ectasia. The top of the protruding cone that corneal configuration may be close to the visual axis or below and nasal of that. The disease manifests during adolescence, followed by slow progressive course, although it is possible to stabilize anytime. In 85% of cases both eyes are affected, but the severity of the attack can present significant asymmetry.
Detailed description
Often in keratoconus a positive family history is present. Prevelance of keratoconus varies greatly worldwide.The reported prevalence of keratoconus varies widely depending upon the geographic location, diagnostic criteria used, and the cohort of patients selected. Environmental factors may contribute to the wide variation in prevalence.
the Middle East have higher prevalence than locations with cooler climates and less sunshine
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with keratoconus | – | Other: opthalmologic examinationpatients with keratoconus attending refractive surgery centers in Assiut will be subjected to the following :- 1. Full history and clinical evaluation. 2. collection of individual data ( residency , occupation , special habbit , chronic illness ) 3. Analysis of results to assess prevelance of keratoconus and its distribution geographically in Assiut |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with keratoconus in people attending refractive surgery
Key inclusion criteria (2 listed)
- persons attending refractive surgery centers in Asssiut.
- patients found to have keratoconus are included , based on history , clinical examination and corneal topography
Key exclusion criteria (3 listed)
- patients not attending those refractive surgery centers.
- patients attending these centers but not diagnosed to be keratoconus .
- Pregnancy or breastfeeding
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 |
|---|---|---|
| opthalmologic examinationopthalmologic examination : Refraction Best corrected visual acuity Intraocular pressure Slit lamp examination | Other | patients with keratoconus |
Primary outcome
Prevalence of keratoconus in different areas in assiut
Time frame: one year
Number of keratoconus cases detected areas in indivduals attending refractive surgery centers in Assiut
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 19674732Jonas JB, Nangia V, Matin A, Kulkarni M, Bhojwani K. Prevalence and associations of keratoconus in rural maharashtra in central India: the central India eye and medical study. Am J Ophthalmol. 2009 Nov;148(5):760-5. doi: 10.1016/j.ajo.2009.06.024. Epub 2009 Aug 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Prevalence of keratoconus in different areas in assiut (time frame: one year). 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 NCT04092426, 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 17 Sep 2019.