KeratoconusNCT03450213
Astigmatism in Keratoconus Patients
A study testing Pentacam in people with Keratoconus, run by Assiut University.
Trial summary
Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Pentacam
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with keratoconus using the following criteria:
- Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening .
Who cannot join
- Unwillingness to participate in the study .
- Corneal scarring.
- Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration .
- Previous ocular surgery.
About this study
Official title: Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls
Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.
Read the detailed description
Keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.Pentacam used diagnose \& detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography.
In the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian.
The aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .
- Conditions
- Keratoconus
- Being tested
- Pentacam
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentacamDevice
Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Patients with keratoconus | Active comparator | Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex. Receives: Device: Pentacam |
| Normal people at the same age and sex | Placebo comparator | Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex. Receives: Device: Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between astigmatism in patients with keratoconus and normal people.
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450213
- Sponsor's protocol ID
- Keratoconus
- Status last verified
- Oct 2018
- First submitted
- 23 Feb 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
PubMed 9493273
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls
- ClinicalTrials.gov ID
- NCT03450213
- Acronym / sponsor ID
- Keratoconus
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 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
- 1 Mar 2018 (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 bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.
Detailed description
Keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.Pentacam used diagnose \& detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography.
In the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian.
The aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with keratoconus | Active comparator | Device: PentacamPentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex. |
| Normal people at the same age and sex | Placebo comparator | Device: PentacamPentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with keratoconus using the following criteria:
- Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening .
Key exclusion criteria (4 listed)
- Unwillingness to participate in the study .
- Corneal scarring.
- Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration .
- Previous ocular surgery.
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 |
|---|---|---|
| PentacamPentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism. | Device | Normal people at the same age and sex, Patients with keratoconus |
Primary outcome
Comparison between astigmatism in patients with keratoconus and normal people.
Time frame: Two years
Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 9493273Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
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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?
A study testing Pentacam in people with 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 4 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 Oct 2018. 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. Some participants in this study may receive a placebo. 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?
Comparison between astigmatism in patients with keratoconus and normal people. (time frame: Two years). 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 NCT03450213, 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 Oct 2018.